Quality Assurance Specialist
1 month ago
Job Summary:
We are seeking a highly skilled Quality Control Analyst to join our team at Piramal Pharma Solutions. As a Quality Control Analyst, you will be responsible for executing defined and trained Quality Control department tests for the release of raw materials, in-process products, bulk drug substance, final products, and stability products according to defined procedures and protocols and in accordance with best cGMP work practices, Quality standards, and metrics.
Key Responsibilities:
- Perform batch disposition and stability activities in a proactive and timely manner, which includes Quality Control testing and reporting of raw materials, in-process, bulk drug substance, final products, and stability products to GMP and in accordance with Annex 11 Computerised Systems and 21CFR part 11 Good Documentation Practices for Electronic Data.
- Perform stability study programme activities, storage of in-process, and final products samples, and retention sample management.
- System owners of QC equipment, assisting in equipment periodic reviews, monitoring, and maintaining calibration status of equipment within the Quality Control department.
- Ownership and accountability of deviations, investigations, and laboratory investigations and timely completion of these documents.
- Preparation and update of SOPs, instructions, and protocols and other Quality Control documentation.
- Checking and reviewing of data in compliance with Data Integrity requirements.
- Actively contribute to department and site audit readiness requirements, including any continuous improvement initiatives.
- Calibration of equipment and instruments used to perform QC testing and informing relevant personnel in a timely manner of any failure of calibration.
- Maintain Quality Control information systems.
- Maintain a technical ability, knowledge, and understanding of relevant regulatory requirements for GMP, safety, and environmental policies required to perform the role as QC Analyst.
- Assist in investigation of quality incidents and other problem-solving forums and complete QMS documentation in a timely manner.
- Attend internal and external scientific and technical meetings and conferences where appropriate.
- Carry out general maintenance and housekeeping of equipment and laboratories.
Essential Experience:
Experience within a QC laboratory working to GMP within a recognised quality system.
Ability to organise work within a busy laboratory with experience of writing and working to SOP documentation.
Knowledge of GMP guidelines and regulatory bodies.
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