Performs required analysis for the Pharmaceutical Development Services (PDS) Analytical Development ensuring that all Pharma Services Group (PSG) Standard Operating Procedures (SOP), current Good Manufacturing Practices, current Good Laboratory Practices (GLP) and corporate quality standards are achieved.
- Performs testing and assays in accordance to approved methods and SOPs
- Performs all duties in strict compliance to all quality systems (SOPs, Good Manufacturing Practices)
- Documents all experimental data in accordance with Good Manufacturing Practices and SOPs
- Assists in method validation as directed by AD Supervisor
- Recognizes and reports out of specification (OOS) results or deviations to Supervisor immediately
- Assists in trouble shooting and investigations as required by AD Supervisor
- Complies with all Environmental Health & Safety (EH&S) requirements and participate in EH&S training
- Other duties as required.
- May be essential to perform alternating or rotating shift work (as required).
- B.Sc. in Chemistry, or related science, with hands-on experience in chromatographic and spectroscopic analytical instruments.
- Two years experience in pharmaceutical analytical development.
- Good understanding of basic chemistry, chromatography (eg High Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), thin-layer chromatography (TLC) and spectroscopic technologies (e.g. Ultraviolet (UV), Infrared (IR).
- Good problem solving skills and logical approach to solving scientific problems.
- Interest in improving skills and knowledge in pharmaceutical development. Excellent written and oral communication skills.
- Proficiency with the English language.
- Legibility in documentation as per Good Manufacturing Practices requirement.
- Possesses analytical thinking skills which are applied to solving a complex scientific problems
- An awareness of regulatory requirements in the pharmaceutical industry. Works well in a team environment and cooperates with other members of the team to find a solution.