Quality Assurance Officer

Role Objective:

To manage and execute IPQA activities while ensuring full compliance with cGMP requirements.

Desired Candidate Profile:

• Bachelors degree in Pharmacy / Science
• Relevant experience in IPQA / Quality Assurance within pharmaceutical or medical device manufacturing.
• Good in communication, analytical and coordination skills

Role Requirement:

• To perform the daily IPQA related activity and line clearance related activity..
• To monitor the plant critical areas like clean room (Manufacturing / Filling), Packing, labelling, OBD verification, water system, utility supply area etc. for the GMP compliance.
• To ensure the End to End Control in Manufacturing, packing and material storage activity
• To prepare and review GMP documents such as SOPs, protocol and other relevant documents.
• To review the executed batch manufacturing / packing records and review of COA & analytical data.
• Handling of Control sample management and review of stability sample management procedure and its compliance.
• To involved in process validation and cleaning validation activity.
• To review the Change control, CAPA, Deviation, Market compliant details and involve in investigation.
• Handling and review of non-conformance and its compliance procedure in consultation with respective department head.
• Conduct training to IPQA and production personnel for the IPQA activities
• To ensure the all QA and plant procedure compliance.
• To review the Documents like Master BMR / BPR / MFC / QC Specification (RM, PM, FP) / STP / other external party document / stability study report / APQR etc.
• To participate in the internal / external audit and give compliance for the audit observation.
• To ensure compliance of GMP as per ISO13485, WHO and CMDCAS standards.

Functional Skills:

• In-Process Quality Assurance (IPQA) operations and line clearance activities
• Strong knowledge of cGMP compliance in manufacturing, filling, packing, and storage areas
• Review and control of Batch Manufacturing Records (BMR) and Batch Packing Records (BPR)
• Process validation and cleaning validation support
• Training and coordination with production and IPQA teams

Behavioral Skills Required:

• Strong attention to detail and compliance-driven mindset
• Analytical and investigative skills for deviations and root-cause analysis
• Effective communication skills for cross-functional coordination
• Accountability and ownership of quality and compliance activities
• Problem-solving orientation with preventive approach

Biotech is an Equal Opportunity Organisation promoting diversity while ensuring no discrimination on any ground including gender, race, religion, age, sexual orientation, disability, etc.