Officer - Quality Assurance

Why This Role Matters

Quality Assurance is the foundation of pharmaceutical manufacturing. It ensures that every product released to the market meets defined quality standards, regulatory requirements, and patient safety expectations. A strong QA system minimizes compliance risks, prevents product recalls, and protects the company’s reputation.
At APDM Pharmaceuticals, the Officer / Sr. Officer – Quality Assurance plays a critical role in maintaining GMP compliance, reviewing production documentation, and supporting quality systems at the Sakodara, Gujarat facility. This position directly contributes to regulatory readiness, operational discipline, and continuous quality improvement across manufacturing operations.

Job Description

APDM Pharmaceuticals is seeking detail-oriented professionals for the role of Officer / Sr. Officer – Quality Assurance with 2 to 4 years of pharmaceutical experience. The selected candidate will handle shop-floor QA activities, batch record review, deviation management, and ensure adherence to established GMP systems.
This role requires strong documentation knowledge, investigation skills, and the ability to coordinate effectively with Production, QC, Engineering, and Warehouse teams. It offers structured growth within the Quality Assurance function.

Key Features of the Role

• Direct involvement in shop-floor IPQA monitoring
• Review and approval of Batch Manufacturing and Packaging Records
• Participation in deviation, CAPA, and change control systems
• Exposure to validation and qualification documentation
• Support during internal and regulatory audits
• Cross-functional coordination across departments
• Career progression within QA hierarchy

Responsibilities

• Perform line clearance before manufacturing and packaging operations
• Review Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR)
• Conduct in-process quality checks as per approved procedures
• Monitor GMP compliance on the production floor
• Handle deviations and support root cause investigations
• Initiate and track Corrective and Preventive Actions (CAPA)
• Manage change control documentation and impact assessments
• Coordinate sampling activities with QC department
• Ensure compliance with Good Documentation Practices (GDP)
• Participate in process validation and cleaning validation activities
• Assist during equipment and utility qualification documentation
• Support internal audits and regulatory inspections
• Ensure timely closure of quality events and documentation gaps

Required Qualifications

• 2 to 4 years of pharmaceutical Quality Assurance experience
• Exposure to IPQA or manufacturing QA functions
• Strong understanding of GMP and GDP requirements
• Experience in deviation and CAPA handling
• Knowledge of documentation control systems
• Basic understanding of regulatory compliance expectations

Educational Requirements

• B.Sc / M.Sc in Life Sciences or Chemistry
• B.Pharm / M.Pharm preferred
• Strong academic background in pharmaceutical sciences

Experience and Skills

• Hands-on experience in manufacturing QA or IPQA
• Strong documentation review capability
• Analytical skills for investigation and root cause analysis
• Knowledge of validation documentation practices
• Understanding of data integrity principles
• Good communication and coordination skills
• Ability to work in a team-oriented manufacturing environment
• Familiarity with ERP or Quality Management Systems preferred

Salary Insights

• Performance-based growth opportunities
• Exposure to regulated pharmaceutical manufacturing environment
• Clear progression pathway toward Assistant Manager – QA

Company Overview

APDM Pharmaceuticals is a growing pharmaceutical organization committed to delivering safe and high-quality healthcare products. Operating from its Sakodara, Gujarat manufacturing facility, the company emphasizes regulatory compliance, operational excellence, and continuous improvement across all departments.
The organization provides a professional and growth-oriented environment for individuals seeking long-term careers in pharmaceutical quality and manufacturing operations.

FAQs

Q: Is pharmaceutical QA experience mandatory?
Yes, 2 to 4 years of relevant QA experience is required.

Q: Will the role involve shop-floor monitoring?
Yes, regular IPQA and GMP compliance activities are part of the role.

Q: Is audit exposure required?
Audit participation is preferred but not mandatory.

Q: What determines Officer vs. Senior Officer level?
Experience depth, independent handling capability, and compliance exposure determine the designation.

Application Tips

• Mention dosage forms handled such as OSD or Injectable
• Highlight deviation, CAPA, and change control experience
• Include audit participation details
• Quantify batch record review experience
• Showcase shop-floor QA monitoring exposure clearly
• Present measurable compliance achievements in your resume