Senior Executive-QA

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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

Engineering Assurance professional with 5–6 years of experience in ensuring compliance, reliability, and performance of engineering systems in regulated environments. Experienced in conducting internal audits, vendor qualification, equipment qualification (IQ/OQ/PQ), and ensuring adherence to GMP, SOPs, and regulatory standards.

Skilled in deviation handling, CAPA implementation, risk assessment, and documentation review to maintain quality and operational excellence. Proven ability to collaborate with cross-functional teams, support inspections, and drive continuous improvement initiatives. Strong knowledge of engineering controls, utilities, and validation practices with a focus on compliance and data integrity. Key Responsibilities:

• Ensure compliance of engineering systems with GMP, regulatory guidelines, and company SOPs.
• Perform and support equipment qualification activities (IQ, OQ, PQ) and requalification.
• Review and approve engineering documents such as URS, DQ, protocols, reports, and SOPs.
• Conduct internal audits and support external/customer/regulatory audits.
• Handle deviations, change controls, and CAPA related to engineering systems.
• Perform risk assessments (FMEA/Risk-based approach) for equipment and utilities.
• Ensure proper maintenance and calibration of equipment and critical instruments.
• Monitor and review utility systems (HVAC, water systems, compressed air, etc.) for compliance.
• Ensure data integrity and proper documentation practices in all engineering records.
• Coordinate with cross-functional teams (QA, Production, QC, Warehouse) for compliance activities.
• Support vendor qualification and evaluation of engineering service providers.
• Drive continuous improvement initiatives in engineering and compliance systems.

Key Skills & Competencies

• Strong knowledge of GMP, GDP, and regulatory requirements (USFDA, EU GMP, WHO).
• Hands-on experience in qualification and validation activities.
• Good understanding of utilities and facility systems.
• Expertise in deviation investigation and CAPA management.
• Strong documentation and audit handling skills.
• Problem-solving and analytical thinking.
• Effective communication and teamwork abilities.

Master of Science (MSc)