Quality Assurance Manager
Resume:
Jawaid Uppal
Res. Tel # 905-***-**** & Cell # 416-***-****.
e-mail: *******@*****.***
OBJECTIVE
To pursue a Process/Equipment/Cleaning Validation position as a charted chemist of Ontario, utilizing my broad spectrum of technical skills for Validation excellence in industry.
KEYWORDS
Consultant / Coordinator Validation, Project Management (PMP), Protocol writing,
Analytical Chemist, cGMP, GLP, SOP, WHMIS, QC, QA, SAP, LIMS, Technology-
transfer, Chemical and pharmaceutical manufacturing & testing, Waste reduction,
Environment improvement plan, Process improvement, Occupational health
and safety, Technical report writing, KT-Investigation and CAPA,TQM, Bachelor in Chemistry,ISO-9002,ISO-
14001,etc
ACCOMPLISHMENTS & PERSONAL SKILLS SUMMARY
•Writing validation protocols (IQ/OQ/PQ) for new equipment/process/ cleaning validations equipment / processes / as well as for periodic re-validations of existing equipment / processes and utilities.
•Development and Implementation of ISO-9002 and ISO-14001, Development of Environmental Improvement Plan for EPA.
•GMP: Experience of working as per cGMP, GLP & SOPs.
•Co-ordination: Proven team player with professional attitude.
•Knowledge of TPP, ICH, USP,HPFBI,FDA and validation guidelines
•Lead Investigator, KT- and SME-Validation
•Exceptional oral, written and presentation skills communication skills
•Computer & other skills: SAP-QM, PM and MM, Track-wise, Content 7 Microsoft Words, Excel, Project, Visio & Power Point.
WORK HISTORY
APOTEX INC.
Richmond hill, Ontario, CANADA 2002-till date
Coordinator, Validation (Cleaning, Process & Sterilization)
•Perform thorough Risk Assessment on a product by product basis to determine the validity and type of validation activities required.
•Creating Validation Master Plans and Validation Plans for:
a. Analytical Test Methods
b. Manufacturing and Packaging processes
c. Cleaning
•Prepares and/or reviews following documents:
-Risk assessment reports,
-Protocols
-Final Summary reports related to cleaning validation.
•In developing cleaning validation protocols, products and sampling locations are selected to represent worse case conditions and the sampling and testing criteria are designed for world-wide regulatory compliance (FDA, HPFBI, EC and ICH standards).
•Prepare reports required for Audits in a short notice ensuring in compliance with external regulatory (HPFBI, FDA) and QA requirements.
•Review and approve Installation Qualification (IQ) and Operational Qualification (OQ) documents relating to concurrent validation activities for product manufacturing, packaging and compounding.
•Provide critique on interim validation reports and prepare final validation summary reports.
•Compile and assess data, conduct statistical analysis for the risk assessment and validation summary reports, ensuring conclusions are based on validated parameters.
•Develop process hold time data for bulk products as well as equipment cleaning parameters (e.g. dirty hold times, campaign parameters, etc.) for filling, packaging and compounding departments.
•Prepare a presentable and defendable validation report for each product line for future internal and external audits
•Well developed technical writing and oral communication skills.
•Superb ability to negotiate and use collaborative skills to develop rapport with external stakeholders
•Ability to manage multiple projects and tasks concurrently and effectively and prioritize work and adapt to change, work independently to meet demanding objectives and tight deadlines.
•Updates the appropriate tracking systems, reviews lab results and summarizes data for validation reports.
•Participates in the execution of cleaning validation protocols including preparation of paperwork and sample bottles.
•Performs visual inspection, samples equipment and delivers samples to the laboratory as detailed in validation protocols and for cleanliness verification using LIMS.
•As a Lead Investigator, conduct investigations and suggest CAPA to solve the validation issues and suggests remedial and corrective actions, as required.
•Files and maintains all support records associated with the cleaning validation program. Evaluates, maintains and orders the necessary sampling supplies required for the validation program.
•Work in a team environment with Operations/Supply Chain, Quality Assurance, Technical Transfer, Analytical Development, Microbiology, Product Development and Regulatory personnel.
AMSON PHARMACEUTICAL LTD, 1999-2002
Manager, Process and Equipment Validation,
•Performed all activities related to QA-Validation manager like documentation control, SOP and documents review for correctness and compliance.
•Creating Validation Master Plans and Validation Plans.
•Departmental update and metrics presentations to upper management.
•Departmental budgeting and annual review of staff.
•Conduct internal and external audits, GMP audits & vendor assessments.
•Approve process/equipment and cleaning validation, qualification and re-validation, assessments and protocols.
•Training of the staff and update their training records.
•Reviewed all stability reports and validation, regulatory documentation.
•Handle all OOS/OOT, CAPA and QMS systems, review of batch records, Annual Product reviews,
•Look after the engineering studies & validation protocols (IQ/OQ/PQ) for validations of equipment / processes / as well as for periodic re-validations of existing equipment / processes and utilities.
•Guide the team in maintaining project tracking systems, using good organizational skills and computer knowledge, to provide customers with current and reliable information regarding the validation status of facility and equipment.
•Experience validating CIP and SIP systems. And technical information related to pharmaceutical systems, utilities, and production equipment Detailed knowledge of industry standard (cGMP, USP, ISPE, etc.) process/equipment/cleaning validation requirements for pharmaceutical systems, utilities, and production equipment.
•Communicate effectively with all levels of the organization through various channels to create procedures, instructions, reports.
•Validation program updates to upper management with minimal supervision.
•Validation protocol review and approval.
•Evaluate and execute re-qualification and revalidation when there is significant change in either product or its manufacturing process and for ongoing validation maintenance.
•Managed the staff of up to 25.
WAH NOBEL ACETATES LTD, 1998-1999
Documentation reviewer & ISO-9002 coordinator
•Using project management skills managed different projects like ISO-14001 and environmental waste reduction.
•Minimizing waste, technical report writing.
•Conducted internal quality audits as per ISO-9002 & ISO-14001 norms.
Preventive maintenance & documentation as per ISO norms.
•Equipment calibration coordinator (ECC), managed a staff of up to 10.
EDUCATION
1 Bachelor of Science in Chemistry 1994-1998
Quaid-I-Azam University, Islamabad, Pakistan
2 PMP (working towards PMP-certification) 2010-till date
Humber College, Ontario, Canada
3 SAP-MM (material management)Certification 2010
Institute of Higher education, Scarborough, Ontario, Canada
4 Qualification & Validation of Pharmaceutical Process & Equipment
Certification 2008
Seneca College of Arts and Technology, Toronto, Ontario, Canada
5 Advanced Pharmaceutical Instrumentation (HPLC) Program 2004-5
Seneca College of Arts and Technology, Toronto. Ontario, Canada
6 Industrial Pharmaceutical Technology Program. 2004-5
Seneca College of Arts and Technology, Toronto. Ontario, Canada
AFFILIATIONS & CERTIFICATIONS
1 PSDM for Investigation & CAPA by KT-Kepner-Tregoe,
2 Japanese Management Tools for Workplace Improvement i.e. KAIZEN,
3 Quality Circles and 5S,
4 Total Quality Management Implementation (TQM),
5 Environmental Regulations for Industries, Water Treatment Operator Training,
6 Member of ACPO ,Charted Chemist of Ontario (C.Chem),
7 Member of CIC, Chemical Institute of Canada.
8 SAP-QM, MM and PM.
ADDITIONAL INFORMATION
-First Aid and CPR trained by St. John Ambulance,
-Volunteer in HABITAT for Humanity, Ontario.
-Volunteer work with Free Eye Donor’s Organization (EDO),
-Interest includes reading, traveling and sculpturing,
References will be furnished upon request.
Contact this candidate