Syed Taha
EDISON,New Jersey
Summary
Experienced in the Pharmaceutical/Biotechnology industries in the areas of CQV, QA-Val, Change Controls, CAPA Admin. Expertise in writing, reviewing, and approving SOP’s, Protocols, AER’s. Final Reports, Master Validation Plan for quality assurance support for validation activities as per company standards and regulatory regulations. Authored, reviewed, executed & wrote validation (IQ/OQ/PQ) protocols and TMVs for systems and processes. Functional Excellence leader driving QMS element, and Good Documentation practice, Data Integrity, and ALCOA principles. Experienced in continuous improvement and process improvement, complaints, supplier onsite audit findings. Extensive experience creating, updating, and reviewing procedures (SOPs), system life cycle documents, work instructions, policies, departmental forms and templates and performing regulatory gap analysis by following 21Part 11, GAMP 4 and GAMP 5 guidance. Proficient in reviewing qualification packages for completeness and accuracy, sound rationale, compliance with validation policies and procedures, and accurate data analysis. Experience in identifying regulatory/compliance issues involving new & existing computer systems and software involving, Strong experience and knowledge of GLP, GCP, GMP in pharmaceutical industry Assured that all validation documentation URS, FRS, SDS, IQ, OQ follow regulatory requirements. (21 CFR Part 210, 211). Specialized in automated testing using HP Quality Centre. Proficient in dealing with Standard Operating Procedures (SOP's), Test Plan, Track Wise modules for CAPA and Complaints Handling, Laboratory Management System (LIMS). Strong experience in equipment commissioning qualification (C&Q). Assisted in procedure development and maintenance, In centrifuges ,temperature humidity meters. Balances, freezers , refrigerators. Excellent written and communication skills with expertise in technical writing. Proficient in Office tools such as Microsoft, Word, Excel, PDF, DOORS, PowerPoint.
Overview
6
6
years of professional experience
Work History
Validation Engineer
Sun pharma (OHM Laboratory ) -NJ
05.2024 - 03.2026
- Design and developed Design Qualification (DQ) and Traceability matrix and tested URS against vendor supplied documents like FRS, SDS, and various manufacturing flowcharts and engineering drawings.
- Identified various gaps in URS, SDS and updated accordingly and created HDS document to close the gaps.
- Supported European vendors for performing onsite vendor Site Acceptance Testing (SAT) qualification.
- Tested URS against Functional Requirement Specification, System Design Specification and Hardware Design Specification to meet company and regulatory requirements.
- Generated three exceptional conditions (EC’s) for electrical insulation test prior to installation, equipment operation testing and GMP/Non-GMP HMI protocol messages/alarms based on criticality and safety.
- Coordinated with various departments including Packaging, QA, Operations and Facilities for various inputs for executing the equipment SAT/IQ/OQ/PQ and summary close out reports.
- Created memos to define strategy for conducting the SAT leveraging activities for critical alarms/messages on HMI.
- Identified safety measures and added pictograms/Labels along with facilities for hot surfaces and critical functions.
- Revised SOP to meet system audit trail functionality for administrators and non-administrators across the plant.
- Wrote summary reports for SAT and IQOQ for successfully closing the qualification and releasing the equipment back to the production for use.
- Performed Validation Assessment for new packaging Equipment’s.
- Performed Periodic Performance Verification for more than 400 Equipment’s in Facility.
- Performed and maintain serialization and aggregation systems in Optel, Pharmaproof, Line Master, including cameras, scanners, and laser printers.
- Performed serialization packaging line IQ/OQ/PQ validations.
- Identify, investigate, and troubleshoot deviations across multiple concurrent projects.
- Performed temperature Mapping , Area qualifications and warehouse.
- Developed calibration plans for newly installed equipment.
- Monitor and follow up on maintenance work orders to ensure proper completion and documentation.
- Installed and Qualified the Pure Water Systems
Validation Specialist / Engineer
Regeneron Pharmaceuticals – NY
01.2022 - 02.2024
- Wrote test plans and IOQ documents, flow diagrams to support validation engineering activities.
- Authoring, editing, reviewing, evaluating, and maintaining department cGMP, GXP, GDP which includes documentation: standard operating procedures, procedural quizzes, work instructions, standard engineering specifications, job aids and keeping up to date on industry standards and regulations by following GAMP 4 and GAMP 5 guidance.
- Revised SOP to meet system audit trail functionality for administrators and non-administrators across the plant.
- Wrote summary reports for SAT and IQ/OQ/PQ, IOQ for successfully closing the qualification and releasing the equipment back to the production for use.
- Identified safety measures and added pictograms/Labels along with facilities for hot surfaces and critical functions.
- Creating/Drawing samples of raw materials and finished products for validation testing and maintaining records according to regulations requirements from FDA- QSR 21 CFR 820, ISO 9001.
- Maintain knowledge on all industry trends for V&V process and development following 21 CFR Part (11, 210, 211, 820, 54), GAMP 5, Annex 11 and e-record/e-signature standards.
- Collaborate with the validation team and identify the turnover of validated systems and processes.
- Coordinate with various validation work tasks and prepare reports to submit to management to ensure quality issues are addressed and resolved prior to release.
- Coordinate with equipment vendors and assist in process fabrication and prepare appropriate reports for approvals.
- Prepare detailed reports or design statements based on results of validation and qualification tests or reviews of procedures and protocols.
- Coordinate the implementation or scheduling of validation testing with affected departments and personnel for monitoring validation test equipment.
Validation Engineer
Amgen, RI
08.2020 - 01.2022
- Supporting development of best demonstrated CQV practices within the validation department, based on current industry practices and regulatory guidelines.
- Prepared and implemented SOPs and Manufacturing Procedures for Sterilization plant for the preparation of Chromatography Skids, Buffer tanks, Buffer Transfer Lines, Column Packing, CIP/COP SOP’s, and Batch Records.
- Approved key deliverables in support of product launch, which includes component qualifications, design and product risk assessments, shelf-life validations, and sterilization validations.
- Preparing a Data Migration Summary Report stating the data migration activities taken place while loading the static data in the LIMS application. Performed gap analysis on all the existing computer systems and software applications against company SOP’s, FDA 21 CFR Part 210/211. Maintained CAPA procedure, initiated investigation of non-conformances through root cause analysis (RCA), evaluation of the effectiveness of process, and initiation of action as required improving effectiveness.
- Analyzed test scripts to be compliant with 21CFR Part 211 regulations, maintaining validation electronic records and following relevant SOPs.
- Supporting development of best demonstrated CQV practices within the validation department, based on current industry practices and regulatory guidelines.
- Prepared and implemented SOPs and Manufacturing Procedures for Sterilization plant for the preparation of Chromatography Skids, Buffer tanks, Buffer Transfer Lines, Column Packing, CIP/COP SOP’s, and Batch Records.
- Reported defects through Quality Center and assigned those reports to the developers. Developed Validation Master Plan (VMP) in accordance with FDA compliance standards.
- Developed IQ/OQ/PQ and MSA protocols by identifying inspection and test activities, special measuring and test equipment, appropriate statistical techniques, data collection methods, and sampling plans for establishing, controlling, and verifying process stability/capability.
- Involved in preparing compliance report about existing status of the cGMP, GCP and GLP.
- Reviewed validation (IQ/OQ/PQ/PPQ/TMV) and provided technical input to ensure validation reports were qualified to company.
- Worked on Data Migration, Periodic Review, Change Controls, and Change Reporting, GAP Analysis, and Risk analysis, FMEA and Remediation Process.
Education
Master of Science in Engineering Management -
Trine University
Angola, Indiana05-2024
Bachelors in Mechanical Engineering - undefined
Osmania University
06-2019
Skills
- Regulatory and Compliance; Risk Analysis and Process Remediation, 21 CFR 820, 21 CFR 211, ISO 13485, GxPs, GLP, GCLP, Root Cause Analysis, ISO11607, ISO 17025, ISO 14971, ISO 12207, GAMP 4-5 and ISO 17799, Document Control/DMR, DHR and QSR Procedures, CAPA Implementation and Resolution, Change Controls, NCMR
Timeline
Validation Engineer
Sun pharma (OHM Laboratory ) -NJ
05.2024 - 03.2026
Validation Specialist / Engineer
Regeneron Pharmaceuticals – NY
01.2022 - 02.2024
Validation Engineer
Amgen, RI
08.2020 - 01.2022
Bachelors in Mechanical Engineering - undefined
Osmania University
Master of Science in Engineering Management -
Trine University