QC Manager

QC Manager- Galway- Pharmaceuticals

This is an opportunity to be part of a dynamic team within the quality function. Our client are looking for individuals to provide technical expertise to assist in the analytical testing on finished product & raw materials using the correct procedures in order to comply with GMP, Health and Safety, SOP’s and environmental and regulatory requirements while ensuring they meet  customer’s needs and to provide support as required to the Head of Quality.

Summary:
• Ensure that all testing is conducted in accordance with current EU and US regulatory requirements. Data integrity is of paramount importance and must comply with current guidelines.
• Ensure completion of testing to allow for timely release of raw materials for use in manufacture and finished product for release to the market.
• Maintenance of the QC stability testing program.
• Ensure timely review and approval of laboratory results, protocols and reports.
• Provide technical guidance in the event of equipment failure, calibration failure, out of specification results and any other issues as appropriate. Ensure all laboratory equipment is maintained and calibrated.
• Perform detailed root cause investigations into out of specification results or any analytical errors that occur in the laboratory
• Ensure timely completion of method transfer activities in accordance with relevant procedures.
• Ensure method development and validation is conducted in accordance with the relevant regulatory procedures and in adherence with the agreed timeframe.
• Ensure adherence to all relevant Standard Operating Procedures (SOP’s), Calibration and Operation Instructions (COI’s) and existing test methods with reference to pharmacopoeia’s, specifications, regulations and industry standards.
• Scheduling of analysis, prioritising work across the company
• Any other duties assigned by the Head of Quality

Qualifications/ Education Requirements:
 

• 3rd level qualification – Bachelor’s degree in a science-based discipline.
• Minimum of 5 years in a pharmaceutical’s environment.
• Strong computer skills in MS Office
• Experience working within a pharmaceutical cGLP Environment; with knowledge of EU GMP and US FDA Guidelines

For further information or a more detailed job description please contact me:
Fiona Fitzsimons
061363318