Senior Executive-QA

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Division
Piramal Pharma Solutions
Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia.
This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation.
Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide.
For more details, please visit : www.piramalpharmasolutions.com
Job Title
Senior Executive-QA
Job Description
To plan, execute, monitor, and maintain the Cleaning Validation Program for manufacturing equipment, ensuring compliance with current GMP requirements, regulatory expectations, company procedures, and Data Integrity principles.
Required Work Experience: 3-5 Years
Prepare and review Cleaning Validation Master Plans, protocols, reports, and risk assessments.
Support lifecycle management of cleaning processes through periodic verification.
Prepare and execute validation studies including initial qualification, revalidation, and cleaning verification.
Perform the Risk Assessment should evaluate potential product-to-product and product-to-cleaning agent carryover risks.
Plan and oversee swab and rinse sampling activities.
Ensure sampling is performed as per approved procedures and protocols.
Verify sampling locations and recovery study applicability.
Coordinate sample submission and testing with the Quality Control laboratory.
Technical Competencies
Cleaning Validation lifecycle approach.
Swab and rinse sampling techniques.
PDE/HBEL calculations and MACO determination.
Risk assessment tools (FMEA, DIRA, HACCP).
Validation documentation and GMP requirements.
Statistical evaluation and trend analysis.
Data Integrity principles (ALCOA+).
Knowledge of regulatory guidelines including USFDA, EU GMP Annex 15, PIC/S, and Schedule M.