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Apply for this job
Details
QA Associate Specialist - Shift
Reference: | RK22685 | Location: |
Carlow |
Qualification: | Degree | Experience: | 4-5 Years |
Job Type: | Fixed Term Contract | Salary: | Not Disclosed |
May be suitable for:
QA Specialist
QA Associate Specialist - Shift
RK22685
Contract – 11 months
On site - Carlow
We’re currently recruiting for an exciting opportunity with a multinational Pharmaceutical organization based in Carlow. This is an excellent position for anyone who is looking to join a leading multinational at an exciting growth period.
Duties
- Responsible for ensuring manufacturing of drug products is in compliance with cGMP and associated regulatory requirements
- Responsible for reviewing and approving GMP documentation to support corporate compliance/regulatory expectations for manufacturing operations.
- Ensure that objectives are effectively achieved, consistent with company requirements to ensure compliance, safety and reliable supply to customers.
- Review and approval of batch documentation, SOPs, cleaning verification and validation data, training and other QMS documentation
- Liaise with the Quality Specialists/QP/QA Lead to resolve queries relating to batch manufacturing process.
- Provide quality oversight including training on all aspects of QMS and GMP and provide quality support for day to day operations
- Provide effective real time on the floor support for day to day manufacturing operations for example area clearances, batch record reviews, aseptic operations.
- Participate in Plant/Quality committees to help set the direction for plant wide GMP initiatives
Education & Experience
- Third Level Degree qualified in a Science/Technical or related discipline.
- GMP audit experience in pharmaceutical industry
- Relevant experience in a quality role, ideally in a pharmaceutical manufacturing environment.
- Knowledge of US and European cGMP guidelines, and other international regulatory requirements, as applicable to the site.
- Report, standards, policy writing skills required.
If interested in this posting please feel free to contact Rachel Kent at Life Science Recruitment for further information.
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Life Science Recruitment | Tel:+353 1 685 4848 | Fax: +353 (0)1 443 05 24 | Email: [email protected] | Copyright © 2021 Life Science Recruitment Ltd
This site uses cookies. More information on cookies can be found in our Privacy Policy | Terms of Use | Registered as a private limited company. No: 445328
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