- Professional
- Bureau à Digwal
The Senior Executive – QA (Engineering Assurance) will be responsible for executing and reviewing qualification lifecycle documents for GMP equipment, utilities, and facilities. The role includes oversight of URS, DQ, IQ, OQ, and PQ protocols, engineering change controls, risk assessments (FMEA), and periodic requalification activities. This position works closely with Engineering, Validation, Projects, and cross-functional QA teams to ensure timely qualification and regulatory readiness.
Key Responsibilities:
- QA review and approval of qualification protocols and reports (URS, DQ, IQ, OQ, PQ)
- Oversight on facility, utility, and equipment qualification activities
- QA support for engineering change controls and deviation handling
- Risk assessment and mitigation using tools like FMEA and HAZOP
- Periodic review and requalification planning
- Participation in internal/external audits and regulatory inspections
- Ensuring data integrity and documentation compliance across qualification records
Qualifications
- B.Tech / M.Tech / B.Pharm / M.Pharm / M.Sc. with specialization in Engineering, Life Sciences, or related field
- 5–8 years of relevant experience in QA Engineering or Qualification/Validation domain
- Strong knowledge of GMP regulations (USFDA, MHRA, EU) and qualification standards (ISPE, WHO, ICH Q9, Q10)
- Hands-on experience in equipment/facility qualification, HVAC, water systems, and cleanroom validations
- Excellent documentation review, risk assessment, and communication skills
About Company
Piramal Pharma Solutions (PPS) is a Contract Development and Manufacturing Organization (CDMO) offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our customers 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 such as the development and manufacture of highly potent APIs, antibody-drug conjugations, sterile fill/finish, peptide products & services, and potent solid oral drug products. PPS also offers development and manufacturing services for biologics including vaccines, gene therapies, and monoclonal antibodies, made possible through Piramal Pharma Limited’s investment in Yapan Bio Private Limited. Our track record as a trusted service provider with experience across varied technologies makes us a partner of choice for innovators and generic companies worldwide.
Company
In the three decades of its existence, Piramal Group has pursued a twin strategy of both organic and inorganic growth.
Driven by its core values, Piramal Group steadfastly pursues inclusive growth, while adhering to ethical and values-driven practices.
Equal employment opportunity
Piramal Group is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, ethnicity, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, genetics, or other applicable legally protected characteristics.
We base our employment decisions on merit considering qualifications, skills, performance, and achievements. We endeavor to ensure that all applicants and employees receive equal opportunity in personnel matters, including recruitment, selection, training, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions, including reasonable accommodation for qualified individuals with disabilities as well as individuals with needs related to their religious observance or practice.
