Senior QA Executive – Formulations

Job Title: Senior QA Executive – Formulations

Department: Quality Assurance
Location: Cherlapally,Hyderabad
Experience: 4–8 years (Formulation QA)
Qualification: B.Pharm / M.Pharm/Msc Chemistry
Industry: Pharmaceutical Formulations (Pellets)

Job Summary:

We are seeking a highly skilled and detail-oriented Senior Quality Assurance Executive with strong experience in pharmaceutical formulations. The candidate will be responsible for implementing, reviewing, and maintaining quality systems, documentation, and regulatory compliance activities, ensuring adherence to cGMP and international regulatory standards.

Key Responsibilities:1. Documentation & Compliance

• Preparation, review, and control of Standard Operating Procedures (SOPs), Specifications, and Master Formula Records (MFRs).
• Preparation and review of Certificate of Analysis (COA) and Method of Analysis (MOA) for raw materials, intermediates, and finished products.
• Preparation and maintenance of Validation Protocols and Reports (VQ/IQ/OQ/PQ) for equipment and utilities.
• Review and approval of batch manufacturing records (BMR/BPR) and ensuring GMP compliance.
• Preparation and review of water system reports (RO, Purified, and WFI), environmental monitoring records, and microbiological data.
• Preparation and submission of Drug Master File (DMF) and supporting technical documentation for regulatory submissions.
• Review and approval of change controls, deviations, OOS/OOT, CAPA, and risk assessments.

2. Validation & Qualification

• Support in process validation, cleaning validation, and equipment qualification.
• Preparation of validation master plan, protocols, and summary reports.
• Coordination with Engineering and Production teams for execution of validation activities.

3. Quality Systems & Audits

• Ensure compliance with GMP, GLP, GDP, and ISO standards.
• Participate in internal audits, vendor audits, and regulatory inspections (USFDA, MHRA, WHO, TGA, etc.).
• Review and monitor implementation of corrective and preventive actions (CAPA) post audits.
• Maintain and improve quality metrics and documentation control systems.

4. Training & Continuous Improvement

• Conduct periodic training on SOPs, cGMP, GDP, and documentation practices.
• Support continuous improvement initiatives in QA processes and quality systems.
• Liaise with cross-functional departments (Production, QC, Regulatory Affairs, Engineering, R&D).

Job Type: Full-time

Pay: ₹300,000.00 - ₹700,000.00 per year

Work Location: In person