DR ANTHONY MELVIN CRASTO,WorldDrugTracker, helping millions, A 90 % paralysed man in action for you, I am suffering from transverse mylitis and bound to a wheel chair,With death on the horizon, This will not stop me, Gods call only..........
DR ANTHONY MELVIN CRASTO Ph.D ( ICT, Mumbai) , INDIA 29Yrs Exp. in the feld of Organic Chemistry,Working for GLENMARK PHARMA at Navi Mumbai, INDIA. Serving chemists around the world. Helping them with websites on Chemistry.Million hits on google, world acclamation from industry, academia, drug authorities for websites, blogs and educational contributio
n

Wednesday 14 October 2015

Khyati khanna

khyati khanna

Khyati khanna

Assistant Manager- Intellectual Property Management

Dr. Reddy's Laboratories
LINKS

Khyati Khanna - Google+

  

 

Experience




Research Scientist

Hikal Ltd, Pune
February 2015 – May 2015 (4 months)



Research Associate

Jubilant Life Sciences Ltd
June 2011 – June 2014 (3 years 1 month)Noida Area, India



Analytical Chemist

Bureau Veritas Consumer Products Services
September 2010 – May 2011 (9 months)



Trainee

Jubilant Organosys Ltd
January 2010 – June 2010 (6 months)
done internship in jubilant organosys



Education




Banasthali Vidyapith

M.Sc in Pharmaceutical Chemistry, Pharmaceutical Chemistry
2008 – 2010



WIPO

DL-101, Certificate Course On Basic of Intellectual Property Rights






National Academy of Legal Studies and Research (NALSAR University Of Law)



Map of nalsar university of law








Shameerpet, Hyderabad, 
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Elizabeth Quijano


Elizabeth Quijano, ASQ CQA/CBA

Elizabeth Quijano, ASQ CQA/CBA

Quality Compliance Professional/ Certified Quality/Biomedical Auditor (ASQ-CQA/CBA)/GMP Trainer/B.Sc. Biochemistry

 

E-mail: lizquijano@live.com
Tel: 416-843-0611

  

Summary

Process driven Quality compliance professional with 11 years demonstrated experience in GMP compliance strategy, set-up, and implementation related to the manufacturing, importation (MRA and non-MRA) and distribution of pharmaceuticals, biologics, medical devices and natural health products. Extensive knowledge in Current Good Manufacturing Practices (cGMP) for biologics, pharmaceuticals and natural health products, USFDA CFR 210-211, USFDA 820, ICH, Medical Device Regulation, ISO 13485 and ISO 9001, Good Distribution Practices, and Good Pharmacovigilance Practice (GVP).
Certification: Certified Quality Auditor (ASQ)
: Certified Biomedical Auditor (ASQ)
Education: B.Sc. Biochemistry
Specialties:
• Regulatory inspection
• Regulatory communication
• Establishment/Site Licensing
• GMP audit
• GMP training
• Product Release (i.e. BGTD Lot Release, Special Access Programme)
• Product Testing (i.e. Stability, Confirmatory, Identity)
• Quality Management System (i.e. Deviation, Corrective/Preventative Action (CAPA) and Out of Specification (OOS) Investigation, Change Control, Complaint and Adverse Reaction)
• Quality Agreements
• GMP Compliance (i.e. Validation, Annual Product Review, Batch Record Review, Alternate Sample Retention, Unique ID Certification)
• GMP records (i.e. Standard Operating Procedure, protocol, reports, checklist)
• Logistics GMP (i.e. Transportation Studies)
 Liz Quijano

Liz Quijano

@ElizabethQuijan

Experience



Quality Compliance Professional, ASQ Certified

Compliance strategy, set-up, and implementation to pharmaceutical and medical device industry
2015 – Present (less than a year)Canada
Manage activities related to company's compliance to GMP or Medical Device Regulation. This will include GMP audit, Training, Change Control, CAPA, Complaint and Adverse Event, RECALL,
Annual compliance (i.e. Stability and Confirmatory testing, Annual Product Quality Review, Batch Record Review, Annual Validation Summary Reports) ,develop GMP records (i.e Quality Agreement, Standard Operating Procedures) and product release. Host regulatory inspections.
Continuously improve the overall quality system. Track quality assurance metrics for the organization. Manage relationship with vendors and regulatory authorities. Manage all activities specific to Establishment/Site Licensing.


Continuing Education Professor

Humber College
2011 – Present (4 years)Ontario, Canada
Course:
Communication Techniques for Quality Assurance (2011-2012)
Topics:
Business Correspondence
How to write SOP
How to write informational, analytical and recommendation report
How to write positive, negative and persuasive message
Listening skills
Team Dynamics
How to deliver presentation
How to provide feedback


Senior Quality Lead

Unilever
2013 – 2015 (2 years)Toronto, Ontario, Canada
Managed all activities related to Unilever’s compliance to all applicable Health Canada regulation for the importation and distribution of DIN and NHP products. Ensure foreign sites, warehouse and laboratories are in compliance to Canadian GMP. Managed all activities specific to Establishment/Site Licensing application/amendment and renewal of Unilever Canada, foreign sites and warehouse.


QA Consultant

PharmEng Technology
2012 – 2013 (1 year)Ontario, Canada
Provided consulting services to pharmaceuticals, biologics, natural health products, cosmetics, disinfectants, active pharmaceutical ingredients and medical devices companies.
Projects:
Quality Control Officer
GMP Audit
GMP Training
Annual Product Quality Review Preparation
Development of Standard Operating Procedure (SOP)


Instructor

Academy of Applied Pharmaceutical Sciences
2012 – 2012 (less than a year)Ontario, Canada
Course: Good Manufacturing Practices (Level I)


Complaints Specialist

Agfa Healthcare
2011 – 2012 (1 year)Waterloo Ontario Canada
Reviewed complaints for appropriateness of root cause analysis, completion and effectiveness of Corrective and Preventative Action (CAPA) and compliance to all applicable regulations and current procedures.


QA Manager

Summit Veterinary Pharmacy Inc.
2010 – 2011 (1 year)Toronto, Ontario, Canada
Set up and implemented Quality Management Program


Quality Specialist

Baxter Healthcare
2006 – 2010 (4 years)Toronto, Ontario, Canada
Managed all activities related to product release and compliance of biologics, drug imports (MRA and non-MRA), medical devices, clinical trial products and Special Access Programme (SAP) products to GMP, Medical Device Regulations and Baxter Quality Management System. Oversee UPS-SCS compliance to GMP, Medical Device Regulations and Baxter Quality Management System.


QA Manager

Pax-All Manufacturing Inc.
2004 – 2006 (2 years)Toronto, Ontario, Canada
Managed all activities (i.e. release, development of specifications, deviation and CAPA, complaints, supplier non-conformances, in process testing, batch record review) related to Pax-All’s compliance to ISO 9001, Health Canada Good Manufacturing Practices and customer requirements for the manufacture of Category IV monograph and Natural Health Products.


Laboratory Technician

Pax-All Manufacturing Inc.
2003 – 2004 (1 year)Missssauga, Ontario, Canada
Provided support to the Quality Assurance Manager on the development of Quality Management System that met Health Canada and ISO 9001 certification.

Education



Humber College

Quality Management Program

Course Taken:
Quality Concepts
Quality Auditing
Six Sigma


Seneca College of Applied Arts and Technology

Certificate, Regulatory Affairs and Quality Operations

Course Taken:
Pharmaceutical Manufacturing and Formulation
Regulatory Affairs Level I and II

Volunteer Experience & Causes



Workshop Provider

American Society for Quality (ASQ)
November 2012Education
Title: Effective Business Correspondence
Scope:
This course focused on one of the most basic type of communication that happens in the workplace, business correspondence. In this course, participants learned the different types of correspondence common in the workplace and their uses, the process in writing correspondence, how to write correspondence that will obtain the maximum audience...more


Workshop Provider

American Society For Quality (ASQ)
May 2013Science and Technology
Seminar: Handling Regulatory Inspection In The Pharmaceutical Industry
Scope:
This interactive seminar focused on strategies for handling regulatory inspection in the pharmaceutical indsutry . In this seminar, participants got an overview of the audit process, how to prepare their facility and personnel for an audit, audit do’s and don’ts, and how to respond to audit questions.
This...more


Designation: Competent Communicator (CC), Advanced Leader Bronze (ALB)

Toastmasters International
2011 – Present (4 years)Education
o President, U-Toast Club, 2014-2015
o Vice President Education, U-Toast Club, 2013-2014
o President, Power Speaking Club, 2013
o Vice President, Public Relations, 2012
o Club International Speech Contest (1st Place), 2013
o Club Humorous Contest (1st Place), 2012
o Event Speaker at District 86 Speakers Bureau, 2012-2013

Honors & Awards

ISO 13485:2003 Lead Auditor (TPECS)

BSI
August 2015
Certification # 8282933-142427

Additional Honors & Awards

ASQ CQA (Certified Quality Auditor)
ASQ CBA (Certified Biomedical Auditor)






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Bina Patel

Bina Patel

Bina Patel

Global Manager, Quality Compliance & Audit System - Corporate at Apotex Inc.

Summary

Highly skilled Quality Assurance professional with 17-years of experience in the pharmaceutical/Nutraceutical industry. Extremely knowledgeable in overall Solid dosage manufacturing process ,Quality Assurance Compliance functions and Quality management system. Hosted FDA and Health Canada inspection. Experienced with Consent decree process handling. Possess the ability to interest and convince others when changes are required. Presentation and technology leading skills, results-oriented person. Tactful team player with excellent people skills. Highly adept at managing multiple priorities.Developed and implemented Incident investigation, CAPA, Change control ,External /internal audit, Stability, Annual product review and Customer complaints quality systems.Familiar with GMP ,Health Canada guideline, MHRA, EU, ICH, GCP ,GLP and 211 CFR .
Certified Quality Control Practitioner

Experience




Global Manager, Quality Compliance & Audit System- Corporate

Apotex Inc.
August 2014 – Present (1 year 3 months)150 Signet Road ,Toronto
Responsible for the development, implementation, maintenance and improvement of systems
supporting the Corporate Quality Audit function. Monitors adherence to the Quality Audit Schedule,
updating and reporting metrics and trends. Tracks execution of individual audits. Analyses data,
identifies risk and escalates concerns appropriately. Coordinates teams across boundaries. Supports and contributes to the Corporate Quality as required.
Manages requests for Due Diligence visits/audits and ensures requests are appropriately supported along with the Global Quality Audit Schedule.
Coordinates and assists, across boundaries, Managers, Senior Auditors and Auditors in the
planning and allocation of supplier audits according to the Global Quality Audit Schedule, tracking
and assuring adherence to the Schedule, and making efficient and effective use of resource.
Manages the Global Audit Schedule of Apotex sites, liaising and facilitating the audit timings and arrangements as required.
Tracks the execution of individual quality audits to assure compliance with Apotex SOPs and
Regulator expectations.
Responsible for suggesting/evaluating improvements to the audit system, making changes to the system, working with departments within and outside QA to improve quality as related to the
system, and training personnel on the system.
Works with the management to ensure the continuous development and improvement of supplier audit programs and systems.
Provide logistics support during inspections of regulatory agencies and customers, and provision of audit reports across boundaries.
Prepare, update and review proposed changes to SOPs, as required.
Ensure that all work is performed in full compliance with current Good Manufacturing Practices,
Standard Operating Procedures, all regulatory requirements, and established safety standards.



QA Compliance Manager

SUN PHARMA
January 2013 – July 2014 (1 year 7 months)Greater Detroit Area
Promoting quality achievement and performance improvement throughout the organization.
Manage the Quality Assurance Compliance specialists
Setting QA Compliance objectives and ensuring that targets are achieved.
Collating and analyzing of product performance data against defined parameters.
Review and Evaluate the Quality systems trending report.
Ensures the procedures are properly understood, carried out and evaluated and product modifications are investigated if necessary;
Provides the suggestion and needed changes for improvements to the process owner of SOP to ensure cGMP.
Driving the group to plan, formulate, and train on comprehensive quality procedures.
Incident investigation review and coordination.Facilitate Investigations and root cause analysis
Management of short and long-term corrective actions (CAPA).
Coordinate and Perform Internal audits
Compliance review of stability reports , OOS, OOT, and OOC.
Performs the compliance review of Instrument malfunction forms, Document change management form and Change control.
Coordinate the regulatory audits to ensure that guest auditors receive access to needed documentation and staff with minimal disturbance to ongoing operations.
Writing/revising and review of QA related SOPs.
Special projects as required.



Assistant Manager,QA compliance

SUN PHARMA
April 2010 – January 2013 (2 years 10 months)Greater Detroit Area
• Maintain Quality system such incident, CAPA, Change Control
• Coordinate and lead product/process investigations.
• Participate in Internal audit
• Monitor compliance status within the manufacturing plant and distribution center.
• Tracking, trending and monitoring of quality system (Complaint, investigation incident, CAPA, change request)
• Prepare quality system trend reports by collecting, analyzing and summarizing data and trends
• Provides reports to senior management as requested, tracks and reports on quality and performance indicators
Direct supervision of QA compliance specialists
Responsible for issuance of QA documents and/or review of the various document types submitted to the compliance function.
Manage multiple projects
• Creation of Standard operating procedure
Department Training Coordinator (QA)
• Developing Training Module of Quality department
• Developing Employees qualification Matrix as per their job description
• Sets performance objectives and regularly evaluates employee performance to ensure they are meeting both current and future needs
• Scheduling and performing department orientation
• Conducting training of Quality system SOP Incident Investigation
• Perform QA oversight of manufacturing area, such as reviewing cleaning log book, line clearance, and room clearance.
• Backup QA Supervisor as needed
• Review third party investigation report and Review Corrective action report and Initiated corrective action plan
• Worked with Consultants/FDA on Seize inventory release



Senior Quality Assurance Engineer

Caraco Pharmaceutical Laboratories ( Sunpharma)
October 2008 – April 2010 (1 year 7 months)Greater Detroit Area
• Major responsibility is to enhance and ensure consistent application of quality standards, systems and processes in the manufacturing process.
• Investigates all manufacturing issue and Quality incident, non conformance and prepare the investigation report and recommend the corrective action to prevent re occurrence.
• Monitor and follow up on all incidents.
• Ensure the facility in Compliance to cGMP standards



QA Assoiciates

Accucaps Industries Ltd.
June 2008 – September 2008 (4 months)
• Investigates all manufacturing issue and Quality incident non conformances
• Perform line clearance checks
• Perform Visual defects AQL inspections,
• Perform Daily Compliance audits
• Perform In process auditing on all documents communicating results and escalating serious incidents.




QA auditor

Gelcell
May 2005 – May 2008 (3 years 1 month)Windsor, ON
POSITION: QA Auditor
• Ensuring manufacturing, packaging, labeling & holding operations are performed in a manner that prevents adulteration or mislabeling of any product/ raw materials and finished products meet specifications for identity, purity, quality, strength and composition prior to release of Final product.
• Conduct Self-inspections for Facility, equipment, Laboratory to ensure facility in CGMP standard and recommend system to improve production efficiency and quality for continuous improvement
• Investigate issues ,quality and respond to customer complaints .Monitor and follow up on deviation and proposes and approve corrective actions to compliance with regulations and quality
• Issue Rework & Reclaim Documentation.Perform AQL inspection on Finish product.
• Responsible for conducting GMP training for all new employees, existing employees and assuring a high level of GMP competence within the facility and Maintain employee training records.




QA Manager

Suntrition Inc.
May 2001 – May 2005 (4 years 1 month)Windsor , ON
Responsible for biological and chemical evaluation of raw materials, intermediate products, final product, packaging and production facilities. Includes writing and establishing specifications, preparing the certificate of analysis for finished product.
Responsible for all activities involving quality assurance and compliance. This includes audits / inspections, checks and tests for quality control for the manufacture of products.
Participates in research and development activities. This includes development of new formulations, evaluation of chemical and physical properties of active ingredients and excipients.
Participates in quoting, purchase order scheduling and purchasing. Analyses changes or new issues in materials and supply to reduce costs and improve quality. Source the raw materials. Adjusts inventory and forecasts for purchasing. Creates formula as per customer request or suggests methods for better quality.
Technical advisor for Production, Quality and Sales. Technical resource for customers, addresses customer technical needs to ensure customer satisfaction.
Preparation of documents and arrange shipping method for product.
R&D and Process developments
Develop methods to improve production efficiency and quality. Advise Technical Support to Product Development. Recommend better excipents for compressing of tablets and filling of Encapsulation with maintaining the budget and quality. Preparing Master Ingredient sheet for Proposed Product’s of Customer Quotation

Education





APOTEX, CANADA





Apotex Inc.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Canada | Map
Telephone: 1-800-268-4623
Facsimile: 1-800-609-9444
Order Desk : 1-877-4-APOTEX (Toll Free in North America)
General Inquiries: Email

Map of Signet Dr, Toronto, ON, Canada







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