Job Description
Key Roles and Responsibilities:
- Perform batch disposition and stability activities proactively and timely, including Quality Control testing and reporting of raw materials, in-process, bulk drug substances, final products, and stability products, in accordance with GMP, Annex 11 Computerised Systems, and 21 CFR Part 11.
- Follow documentation practices for electronic data.
- Conduct stability study program activities, manage storage of in-process and final product samples, and oversee retention samples.
- Manage QC equipment as system owners, assist with equipment reviews, and monitor calibration status within the Quality Control department.
- Own and be accountable for deviations, investigations, and laboratory investigations, ensuring timely completion of documentation.
- Prepare and update SOPs, instructions, protocols, and other QC documentation.
- Review data for compliance with Data Integrity requirements.
- Contribute to audit readiness and continuous improvement initiatives.
- Calibrate equipment and instruments used for QC testing, and notify relevant personnel of calibration failures.
- Maintain Quality Control information systems.
- Maintain technical knowledge of GMP, safety, and environmental policies relevant to the QC Analyst role.
- Assist in investigating quality incidents and complete QMS documentation promptly.
- Participate in scientific and technical meetings and conferences as appropriate.
- Perform general maintenance and housekeeping of laboratories and equipment.
- Provide coverage for other departments as required.
- Undertake any other duties as assigned by the QC Manager in line with company requirements.
Key Competencies:
- Attention to detail
- Reliability
- Effective communication
- Understanding of scientific and technical processes
Qualifications:
Essential Qualifications:
Degree in a Science discipline is desirable.
Essential Experience:
- Experience working in a GMP-compliant QC laboratory within a recognized quality system.
- Ability to organize work in a busy laboratory environment, with experience in writing and following SOPs.
- Knowledge of GMP guidelines and regulatory bodies.
About Us:
The Piramal Group has grown organically and inorganically over three decades, guided by core values of inclusive growth and ethical practices.
Equal Employment Opportunity:
Piramal Group is an equal opportunity employer, committed to non-discrimination and providing equal opportunities to all applicants and employees.
About The Team:
Piramal Pharma Solutions (PPS) is a CDMO offering end-to-end development and manufacturing solutions across the drug lifecycle, serving global clients with a wide range of services, including biologics, potent APIs, and sterile products.