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Quality Assurance Specialist
2 months ago
Piramal Pharma Solutions is seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality and integrity of our products.
Key Responsibilities- Batch Disposition and Stability Activities: Perform batch disposition and stability activities in a proactive and timely manner, including Quality Control testing and reporting of raw materials, in-process products, bulk drug substance, final products, and stability products to GMP and in accordance with Annex 11 Computerised Systems and 21 CFR part 11 Good Documentation Practices for Electronic Data.
- Stability Study Programme Activities: Perform stability study programme activities, storage of in-process and final products samples, and retention sample management.
- Equipment Management: System owners of QC equipment, assisting in equipment periodic reviews, monitoring, and maintaining calibration status of equipment within the Quality Control department.
- Deviation and Investigation Management: Ownership and accountability of deviations, investigations, and laboratory investigations, and timely completion of these documents.
- Documentation and SOPs: Preparation and update of SOPs, instructions, and protocols, and other Quality Control documentation.
- Data Integrity: Checking and reviewing of data in compliance with Data Integrity requirements.
- Audit Readiness: Actively contribute to department and site audit readiness requirements, including any continuous improvement initiatives.
- Equipment Calibration: Calibration of equipment and instruments used to perform QC testing, and informing relevant personnel in a timely manner of any failure of calibration.
- Quality Control Information Systems: Maintain Quality Control information systems.
- Regulatory Knowledge: Maintain a technical ability, knowledge, and understanding of relevant regulatory requirements for GMP, safety, and environmental policies required to perform the role as a QC Analyst.
- Problem-Solving and Investigation: Assist in investigation of quality incidents and other problem-solving forums, and complete QMS documentation in a timely manner.
- Scientific and Technical Meetings: Attend internal and external scientific and technical meetings and conferences where appropriate.
- Equipment Maintenance: Carry out general maintenance and housekeeping of equipment and laboratories.
Experience within a QC laboratory working to GMP within a recognized quality system.
Ability to organize work within a busy laboratory with experience of writing and working to SOP documentation.
Knowledge of GMP guidelines and regulatory bodies.
