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Alembic Pharmaceuticals
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Executive/ Sr. Executive - Quality Assurance - APQR - Injectable Site

Executive/ Sr. Executive - Quality Assurance - APQR - Injectable Site

Alembic Pharmaceuticals

5 - 8 years

4 - 8 Lacs

vadodara

Posted:3 weeks ago| Platform:

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Skills Required

qa apqr sterile injectables

Work Mode

Work from Office

Job Type

Full Time

Job Description

Role & responsibilities

APQR Preparation & Management:

Collect, compile, and analyze data from various departments (Production, QC, QA, Warehouse, etc.) for APQR.
Ensure timely preparation and completion of APQRs for all marketed products.
Review trends in product quality, deviations, complaints, OOS/OOT results, and change controls.

Compliance & Documentation:

Ensure APQRs are prepared in accordance with GMP guidelines (e.g., USFDA, & EU).
Maintain accurate and complete documentation of APQRs and related records.
Coordinate with regulatory affairs for submission of annual reports when required.

Cross-Functional Coordination:

Liaise with Production, QC, QA, and other departments to gather necessary data.
Facilitate meetings to discuss APQR findings and recommend corrective/preventive actions.

Continuous Improvement:

Identify trends and areas for improvement based on APQR findings.
Support implementation of CAPAs and monitor their effectiveness.

Audit & Inspection Support:

Provide APQRs during internal and external audits.
Address audit observations related to APQRs and ensure timely closure.

Qualifications & Experience:

Masters degree in Pharmacy, Chemistry, or related field.
Minimum 57 years of experience in pharmaceutical quality assurance or documentation.
Strong understanding of GMP, regulatory guidelines, and quality systems.

Skills Required:

Excellent analytical and documentation skills.
Proficiency in MS Excel, Word, and data management systems.
Strong communication and coordination abilities.
Attention to detail and ability to meet deadlines.

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