QA Manufacturing Compliance Specialist
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| Job Type | Fixed Term |
| Area | Sligo |
| Sector | QualityOperations & Manufacturing |
| Start Date | |
| Advertiser | Ashling Guthrie |
| Job Ref | 3007 |
| Job Views | 1259 |
- Description
- Team Horizon is seeking a QA Manufacturing Compliance Specialist for our Client, who are a globally recognised pharmaceutical company. This role is an initial 12-month contract based at their state-of-the-art biologics manufacturing facility.
Why you should apply:
Join a company whose goal is to help patients live healthier lives and are proud to be a Great Place to Work.
Be part of a diverse and dynamic team where you will have the opportunity to work with experienced leader in a globally recognised biotech company.
What you will be doing:
Ensure that products and aseptic process simulations manufactured meet the requirements of the end users, regulatory authorities and of the company.
Providing quality and compliance oversight and assistance to the Operations function of the company to manufacture products in compliance with all site policies and procedures.
Provide quality oversight during the aseptic processing of products, including aseptic intervention observation.
Leading and assisting in investigations arising out of product or manufacturing processes non-compliance.
Review of completed Batch Records.
Drive continuous improvements and simplify site processes and procedure, specifically relating to the Operations function to ensure compliance is maintained at all times.
Completion of Line Clearance, incoming material and product quality checks as required.
What you need to apply:
Bachelor’s Degree, preferably in Science or Microbiology, or equivalent related work experience is required.
3+ years of Biopharmaceutical experience in a sterile aseptic environment.
Knowledge of regulations and standards for pharmaceuticals (e.g. CFR, EU GMP).
Ability to evaluate quality, production and support areas for compliance to GMPs. SOPs, etc.
Ability to identify and investigate problems and help to resolve them.
