This Job Description defines the core role for tasked with maintaining regulatory compliance under ICH Quality Guidelines. The position uniquely bridges the technical requirements of stability testing with operational quality controls. The role spans technical accountability across research and development (R&D;) workflows and active commercial manufacturing scale operations.
Key Responsibilities Covered in the Documentation :
- Stability Protocols (ICH Q1A - Q1F): Designing and managing stability protocols using advanced matrixing and bracketing techniques for both exploratory R&D; and final commercial batches, optimizing storage criteria (temperature/humidity matrices), tracking testing intervals, and evaluating shelf-life trends.
- Document Control: Managing the life cycle of Standard Operating Procedures (SOPs), Batch Records, and analytical protocols under secure, audit-ready archiving frameworks adhering to ALCOA+ data integrity principles.
- Instrument Calibration:
Details ownership of the Master Calibration Schedule, managing analytical hardware qualifications (DQ/IQ/OQ/PQ) for systems like HPLC and GC, and handling Out-of-Calibration (OOC) lifecycle investigations. Perform routine internal and external calibrations on core pharmaceutical laboratory instrumentation using primary, certified reference standards.
We're Looking For:
Strong analytical and problem-solving skills
Good understanding of pharmaceutical analytical techniques
Excellent written and verbal communication skills in English
Ability to communicate with the USA team on day-to-day work activities
Good communication and documentation skills
Eagerness to learn, collaborate, and work in a research driven workplace
Positive attitude with a willingness to take ownership and work effectively in a team