Quality Assurance Executive

Job Title: Quality Assurance Officer / Executive

Department: Quality Assurance

Industry: Pharmaceutical

Job Purpose

To ensure that pharmaceutical products are manufactured, tested, and released in compliance with cGMP, regulatory requirements, and company quality standards, ensuring product safety, efficacy, and quality.

Key Responsibilities

1. Quality Systems & Compliance

Ensure compliance with cGMP, GLP, GDP, and regulatory guidelines (WHO, USFDA, EMA, MHRA, ICH).

Maintain and implement Quality Management Systems (QMS).

Participate in internal, external, and regulatory audits and manage audit responses.

Monitor and implement CAPA for deviations, complaints, and audit findings.

2. Documentation & SOP Management

Review, approve, and control SOPs, policies, protocols, and records.

Ensure data integrity and proper documentation practices (ALCOA+).

Maintain document control and archival systems.

3. Batch Release & Review

Review Batch Manufacturing Records (BMRs) and Batch Packaging Records (BPRs).

Ensure compliance before batch release or rejection.

Coordinate with Production, QC, and Regulatory teams for batch disposition.

4. Deviation, Change Control & Risk Management

Investigate deviations, OOS, OOT, and non-conformances.

Manage Change Control processes and assess impact on quality.

Conduct risk assessments (FMEA, risk analysis).

5. Validation & Qualification

Review and approve validation protocols and reports (process, cleaning, equipment, utility).

Ensure ongoing revalidation and periodic review of systems.

6. Training & Continuous Improvement

Conduct GMP training for employees.

Promote a culture of continuous improvement and quality awareness.

Support implementation of quality metrics and performance indicators.

Required Qualifications

Bachelor’s / Master’s degree in Pharmacy, Chemistry, Biotechnology, or related field.

1–6+ years of experience in Pharmaceutical Quality Assurance (depending on level).

• इस फुल टाइम मैन्युफैक्चरिंग Job में 6 - 24 महीने का अनुभव वाले उम्मीदवारों की जरुरत है।