Senior Executive-QA

Piramal Pharma Ltd; India; On-site; INR 850,000 - 1,250,000; Full time

Job summary

Piramal Pharma Solutions is seeking a Senior Executive-QA to plan, execute, monitor, and maintain the Cleaning Validation Program for manufacturing equipment in a GMP environment.

Responsibilities include preparing validation master plans, risk assessments, and coordinating sampling activities with QC. Requires 3–5 years of relevant experience and strong data integrity knowledge (ALCOA+). Regulatory awareness including USFDA/EU GMP is essential.

Qualifications

• 3–5 years of relevant work experience in QA/Cleaning Validation.
• Experience preparing and reviewing Cleaning Validation Master Plans, protocols, reports and risk assessments.
• Knowledge of regulatory guidelines including USFDA and EU GMP Annex 15.
• Strong data integrity and risk assessment skills (FMEA, DIRA, HACCP).

Responsibilities

• Plan, execute, monitor, and maintain the Cleaning Validation Program for manufacturing equipment in accordance with GMP.
• Prepare and review Cleaning Validation Master Plans, protocols, reports, and risk assessments.
• Support lifecycle management of cleaning processes through periodic verification.
• Coordinate sample submission and testing with the Quality Control laboratory.
• Plan and oversee swab and rinse sampling activities.
• Ensure sampling is performed per approved procedures and protocols.
• Verify sampling locations and recovery study applicability.

Skills

Cleaning Validation

Swab Sampling

Rinse Sampling

FMEA

DIRA

HACCP

ALCOA+ Data Integrity

GMP Compliance

Regulatory Guidelines

Job description

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.