To provide Quality Control SuppoMAIN RESPONSIBILITIESGraduate role specific:
• FP team project & Testing Support
• Running Team Boards & Metrics
• Consumables management support
Roles and Responsibilities:
- Carry out routine analysis on Finished Product samples ensuring compliance with cGLP/cGMP and that turnaround times are met. The testing carried out includes but is not limited to: HPLC, Osmolality, Organic Iodine, Inorganic Iodine, Thin Layer Chromatography, Free aromatic amines, pH, RI, Trom’s, EDTA, Technical tests, Extractable volume.
- Assisting in the maintenance of the stability program
- Actively involved in Investigations
- Logging of samples in LIMS
- Entering results on LIMS, checking results are within specification and also task approval.
- Always ensure compliance with EHS, actively participate in EHS activities and 5s.
- Perform routine instrument calibration checks at appropriate times.
- Preparation and control of Standard Operating Procedures and always ensuring compliance with cGMP guidelines.
- Completion of Documentation for Batch Release process.
- Assisting in the provision of trends
- Assist in audits.
- Generation/ reporting of Key performance indicators for the group.
- Ensure compliance with current pharmacopoeias and all regulatory/company guidelines.
- Interaction with other departments e.g., QA, BU, Sterility assurance etc.
- Keep colleagues informed of current issues and developments as appropriate.
- Carry out additional duties as deemed necessary by your PTL/Senior Analyst PRINCIPAL QUALIFICATIONS:
- A third level Science Qualification
- SkillsREQUIRED: Good communications skills, excellent time management skills, flexibility and agility will be required. Openness to change. Proven ability to work on own initiative and deliver expectations. DESIRED WORK EXPERIENCE: Pharmaceutical experience in a GMP regulated laboratory environment.