PALLAV PARIKH
Hillsborough,NJ
Summary
Dedicated and result oriented professional with 14 years of pharmaceutical experience with a proven expertise in ensuring compliance with regulatory standards, optimizing validation processes, driving quality improvements, and implementing robust quality systems to ensure the quality and safety of pharmaceutical products. Having working experience in vast variety of pharmaceutical formulations enables me with through industrial expertise and versatility for robust quality system and validation programs including Process Validation, Cleaning Validation, Equipment Qualification, Computer System Validation, Hold Time Studies, Media Fills, and Smoke Studies. Effective communicator and collaborator, adept at building strong relationships with internal stakeholders and regulatory authorities. Passionate about driving excellence in pharmaceutical QA and validation practices to deliver safe and effective products to patients worldwide.
Overview
15
15
years of professional experience
1
1
Certification
Work History
Director QA Validation
Imprimis Rx
09.2022 - Current
- Established robust and achievable validation programs to ensure the site meets current US regulatory expectations and is aligned with current industry best practices including integration of appropriate risk-based strategies.
- Established and maintaining the site Master Validation Plan (MVP) to describe approaches for required validation programs including facility, products, equipment, cleaning processes and computer systems.
- Established and managing validation projects by aligning, coordinating, and supervising prioritization of activities according to business plan and immediate needs and successfully validated 9 New Product Launches (NPLs) in last 12 months.
- Established Aseptic Process Qualification (Media Fills) program to assess performance of aseptic manufacturing processes.
- Established Smoke Studies program to ensure unidirectional airflow in manufacturing clean rooms.
- Review and approve validation deliverables (IQ, OQ, PQ, PV, CV, UAT, CSV, risk assessments, reports, etc.) ensuring alignment with validation strategies outlined in Master Validation Plan and relevant site procedures.
- Provide input and support Deviations, CAPAs and Change Controls to ensure that equipment, processes, and systems remain in validated state.
- Successfully validated and implemented Quality Management System software (Veeva) and Electronic Batch Records (Master Control).
- Serve as subject matter expert (SME) for Validation during client audits and regulatory inspections.
- Conduct internal and external audits to ensure compliance with regulatory requirements.
- Designed robust Annual Product Quality Review (APQR) program for continued process monitoring and improvements and support Operational Excellence.
- Established and maintained strong relationship with vendors, ensuring qualification of critical systems and equipment.
- Increased company revenue by streamlining processes and implementing cost-saving measures.
- Provide leadership and management for validation staff through structural process of goal setting, performance appraisal, and individual development.
- Developed high-performing teams by providing mentorship, guidance, and opportunities for professional growth.
Senior Manager QA Validation
Novel Laboratories (d/b/a Lupin Somerset)
11.2013 - 09.2022
- Developed and maintained Validation Master Plan to outline principals involved in qualification of product processes, qualification of equipment, and provide written program for routine monitoring and maintenance of qualified product processes, systems, and equipment.
- Developed and implemented Validation SOPs per company standards and regulatory requirements.
- Reviewed and approved Validation Protocols and Reports for Process Validation, Packaging Validation, Cleaning Validation, Facility Qualification and Equipment Qualification.
- Reviewed and approved Master Batch Records, Tech Transfer Reports during Process Qualification stage to ensure compliance with internal procedures and regulatory requirements.
- Evaluated and approved discrepancies related to Validation Protocols ensuring proper documentation and investigation of incidents and identification of corrective actions.
- Established Product Hold Times, Clean Hold Time (CHT), Dirty Hold Time (HDT) and Campaign Lengths for commercial products and equipment.
- Conducted impact assessment on Maximum Allowable Carryover (MAC) limits of existing commercial products in response to changes including introduction of new product or changes in existing products.
- Supported internal and external audits.
- Performed Continued Process Verification and Process Capability Evaluations as part of Annual Product Quality Review (APQR) to achieve ongoing assurance that product processes remains in a state of control.
- Led team for projects including qualification of Purified Water System, Compressed Air Units, Air Handling Units, and design qualification of manufacturing facility for oral solids and liquid dosage forms.
- Achieved operational excellence by streamlining processes and implementing best practices.
- Improved team performance by providing comprehensive training and fostering a collaborative work environment.
QA Supervisor
Nostrum Laboratories
02.2012 - 10.2013
- Improved overall efficiency of QA department through strategic planning and resource allocation.
- Supervised responsibilities for Manufacturing QA activities including raw material sampling, line clearances, In-process sampling, In-process checks, retain sample activity label control, batch record review and controlled document issuance.
- Reviewed ARFs, COAs and other critical documentation and perform disposition for raw materials, packaging components, labeling materials, and finished products.
- Reviewed Deviations, Investigations, Product Complaints, Validation Protocols and Stability Protocols.
- Prepared and assisted in developing new and revision of existing SOPs for manufacturing and QA department.
- Reviewed work orders, preventive maintenance, and calibration documents for compliance perspective.
QA Associate
Gemini Pharmaceuticals
05.2011 - 02.2012
- Established and maintained a robust Compliance Program for manufacturing area to ensure compliance to cGMP standards, company policies and SOP standards.
- Performed line clearances, In-process sampling, In-process checks during manufacturing processes to ensure product quality and consistency throughout the run.
- Reviewed Master Production Record and Master Packaging Records for executed batches.
- Reviewed and evaluated Change controls, Deviations, and Investigations to comply with quality and regulatory standards.
- Handled retained sample program for Finished Products and Raw Materials.
QA Inspector
Amneal Pharmaceuticals
09.2009 - 05.2011
- Performed line clearances, In-process checks, In-process sampling, and AQL for manufacturing operations to ensure product quality.
- Performed sampling of raw material, packaging components and labeling components as part of release process.
- Performed swab sampling for chemical residue and microbial residue for cleaning validation.
- Prepared new SOPs & revised existing QA SOPs to current practices and regulatory requirements.
- Prepared Annual Product Quality Reviews (APQRs).
Education
Master of Science in Pharmaceutical Manufacturing -
Stevens Institute of Technology
Hoboken, NJ12.2009
Bachelor of Pharmacy -
Rajiv Gandhi University
Karnataka, India12.2006
Skills
- Leadership and Team Management
- Problem-solving and Decision-making
- Budget Control
- Business Planning
- Project Coordination
- Quality Systems
- Risk-Based Validation
Certification
- Six Sigma Green Belt- BMGI
Six Sigma Green Belt Project- Process improvement for dissolution optimization and improve product yield to optimize manufacturing cost for Extended-release tablet product.
Six Sigma Green Belt Project- Developed a tool to auto calculate Maximum Allowable Carryover (MAC) limit for commercial molecules.
Timeline
Director QA Validation
Imprimis Rx
09.2022 - Current
Senior Manager QA Validation
Novel Laboratories (d/b/a Lupin Somerset)
11.2013 - 09.2022
QA Supervisor
Nostrum Laboratories
02.2012 - 10.2013
QA Associate
Gemini Pharmaceuticals
05.2011 - 02.2012
QA Inspector
Amneal Pharmaceuticals
09.2009 - 05.2011
Master of Science in Pharmaceutical Manufacturing -
Stevens Institute of Technology
Bachelor of Pharmacy -
Rajiv Gandhi University
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