Description
QUALITY CONTROL ANALYST
12 months
Amersham
The Quality Control Analyst Position is responsible for carrying out tasks related to raw material, utility, in process, release and stability testing of radiopharmaceutical products as required by Good Manufacturing Practice (GMP).
Duties include (but are not limited to):
- Carry out routine testing of raw materials, drug substances, intermediates and finished products, stability samples in accordance with written procedures & regulatory requirements.
- Ensure correct data entry to electronic product release electronic system.
- Review results generated by other analysts for compliance with requirements.
- Maintain laboratories to a high housekeeping standard.
- Participate in the validation of analytical test methods as required.
- Ensure that laboratory equipment is well maintained and calibrations are carried out at the designated frequencies.
- Write and maintain necessary documentation (test protocols, SOPs, instrumentation manuals and checkout sheets, method transfer reports, OOS reports, etc.) according to the existing SOPs and cGMP standards.
- Maintain current knowledge of industry standards and regulatory requirements for products developed or manufactured by the company, validation techniques/approaches and systems utilised at the company.
- Initiating OOS or Out of Trend Investigations, executing root cause analysis & documenting investigations in accordance with SOP Requirements.
The ideal candidate would possess:
- Bachelor of Science Degree in Chemistry.
- experience in pharmaceutical industry, working in a quality control laboratory.
- Working knowledge of Quality Control testing techniques, (HPLC, UV, Wet Chemistry)
- Experience working in a team environment, adaptability, self-motivation, and a positive attitude.
- Ability to write clear technical documentation.
- Excellent verbal and written communication skills
- Strong computer, scientific, and organisational skills
- Ability to learn new techniques performs multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies.
Desirable
- Chemistry Laboratory and analytical knowledge in a pharmaceutical environment working with radioactive products.