Quality Control Analyst
3 weeks ago
**Position summary**
Initially, this position will focus on providing support to the QC Manager for the transition of all the chemical testing. As the transition is completed, this position will take on responsibility for chemical test operations including method validation and laboratory compliance.
**Responsibilities**
- Testing of raw materials (identity, purity, related substances test), in-process samples, bulk, and finished products to pharmacopeia/in-house standards.
- Work in line with the production schedule to test manufactured bulk and in-process check samples.
- Participate in tech transfer projects
- Write the tech transfer protocol and report
- Assist in managing the regulatory audits
- Update specifications and test records as required.
- Participate in additional product testing, such as stability samples as required.
- Ensure efficient, precise, and accurate reporting of test results in LIMS.
- Support laboratory-based projects.
- Maintain laboratory housekeeping.
- Participate in laboratory investigations for out of specification results, deviations, and non-conformances.
- Support analyst training as required.
- Maintain laboratory quality standards by ensuring a high standard of work conducted at all times.
- Assist with preparing, reviewing, and updating Standard Operating Procedures and Procedures and forms for Testing.
- Ensure equipment and facilities are maintained/prepared in accordance with approved procedures.
- Adhere to GMP and GLP principles.
- Adhere to all safety precautions.
**Education and experience**
- Bachelor’s degree in science or a relevant scientific discipline (Pharmaceutical Science, Chemistry, Biology, Biochemistry, Microbiology etc.).
- 3+ years of experience in the pharmaceutical/veterinary pharmaceutical, biotechnology, or related industry with notable exposure to GMP or in a regulated quality environment.
- Background in Pharmaceuticals will be extremely valued.
- Practical experience with a wet chemistry lab is highly regarded.
- Practical working experience with HPLC/UPLC, NIR, UV spectrophotometer, and auto titrator is essential and exposure to GCMS, AAS, and LC-MS will be an added advantage.
- Practical experience in chemical testing for immunological products
- Understanding of the USP, BP & EP pharmacopoeias.
- Knowledge of GMP and GLP and the regulatory environment.
- Understanding of QC Testing Requirements.
- The successful applicant will need to be Covid 19 X 2 vaccinated and be prepared to have tetanus vaccination due to workplace conditions.
- Given the role responsibilities the incumbent is required to work on site every day.
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