QA Specialist

Job Description

We have an exciting opportunity for a QA Specialist to join an expanding team with a leading pharmaceutical company based in Cork.

You will need to have experience in a Quality background with experience in Batch Record review, FDA/EMEA regulatory regulations and experience in C&Q activities as you will be helping support the Quality Operations & Batch release team.

This role is a 12 month hourly rate contract with the rate depending on experience.

Requirements:

• Supports GMP activities from operational through to batch release.
• Ensure that compliance programs are completed in an efficient manner and are effectively maintained.
• Responsible for implementation of improvements and procedures of change control and deviation management.
• Oversee project activities such improvements within the batch release team, data integrity and system improvements.
• Participate in inspections and internal/external audits.
• Quality oversight of activities including C&Q activities and process validation through to commercial manufacturer.
• Participate in the execution of the QA Team duties.

Vital Experience:

• Bachelors Degree in a Scientific or Technical discipline required
• 3+ years experience in a quality or compliance role within the biological or pharmaceutical industry
• Knowledgeable of FDA/EMEA regulatory requirements
• Experience in C&Q and Process Validation

Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.

BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.