- Experience Level
- Experienced (non-manager)
Truly global Pharmaceutical Company seeks an experienced QC Analyst.
About the role:
Undertake basic analytical testing and associated laboratory duties as necessary and assist the Laboratory Manager in ensuring safety in the laboratory and satisfactory quality standards in the materials manufactured.
Duties may include:
- Tests and analyses pharmaceutical drugs to determine their identity, purity and strength.
- Collects and record receipt of samples from various sources and prepare for analysis.
- Undertake the analysis of incoming samples and finished products to laid down specifications using conventional analytical techniques eg HPLC, GC
- Ensures that pharmaceutical products are stored properly.
- Liaises with other professionals regarding the development, manufacturing and testing of pharmaceutical products.
- Prepare analytical reagents/media/cultures for general laboratory use.
- Ensure that any waste materials are processed, recorded and disposed in accordance with cGLP, safety and environmental requirements.
- Ensure all activities are performed in compliance with customer and ICH procedures.
- Ensure that all instruments are calibrated and adequately maintained prior to use.
- Verifies laboratory data and ensures accurate primary records are kept, reports any anomalies or out of specification results to Section Leader.
- Maintains and supports the Stability program with respect to:
- Stability Reports
- Stability sampling programme
- New product introductions
- PCN requirements
- Reviews stability indicating methods.
- Generates stability reports suitable for inclusion in regulatory dossiers.
- Other reasonable tasks as required by a manager / team leader.
Skills and experience:
- Knowledge of analytical techniques HPLC/GC (including stability indicating methods) and ICH requirements essential.
- HNC/HND or Degree in relevant Science subject an advantage