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Senior Executive-QA

Senior Executive-QA

Piramal Finance

5 - 8 years

7 - 10 Lacs

Medak Telangana

Posted:1 day ago| Platform:

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Skills Required

document review risk assessment gmp regulations qa engineering pq capa equipment qualification oq usfda data validation quality control ipqa documentation iq change control qc quality assurance qms mhra external audit inspection

Work Mode

Work from Office

Job Type

Full Time

Job Description

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

Responsibilities 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

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Piramal Finance

Financial Services

Mumbai

250+ Employees

223 Jobs

Key People

Ajay Piramal

Chairman
Shreyas Tiwari

CEO
Swati Piramal

Vice Chairperson

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Senior Executive-QA