Quality Assurance (QA) Compliance Specialist
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| Job Type | Contractor |
| Area | Sligo, Ireland |
| Sector | Quality |
| Start Date | |
| Advertiser | Ashling Guthrie |
| Job Ref | 1003648 |
| Job Views | 671 |
- Description
Team Horizon is seeking a Quality Assurance (QA) Compliance Specialist for a leading pharma company in Sligo.
Why you should apply:
- Our client has developed a stand-out culture of innovation, inclusion and development, and consistently features as a great place to work.
- They put their people first and live their diversity and inclusion values embracing all perspectives.
What you will be doing:
- Ensure that all products leaving the site meet the standards required for marketed and investigational drug products.
- 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.
- Leading / Assisting in investigations arising out of product or manufacturing processes non-compliance.
- Review/Audit of completed Batch Records.
- Review of Manufacturing Logs as required.
- Completion of quality review of operations documentation (SOPs, JSTMs, Risk Assessments)
- Completion of Incoming Raw Material checks, including product status maintenance (as required).
- Provide Stability Program Support, e.g. sample pulls, weekly checks, protocol generation (as required).
- Administration of Quality Logs, e.g. QA Hold, Sample Request.
- Lead operations floor daily walk around of manufacturing areas.
- Drive continuous improvements and simplify site processes and procedure, specifically relating to the Operations function to ensure compliance is maintained at all times.
- Other support as deemed necessary
What you need to apply:
- A minimum of three years’ experience in a quality/operations role in a highly regulated GMP environment.
- Experience in biologics manufacturing is highly desirable.
- Experience in aseptic processing gained within either a quality or operations role is highly desirable.
- A strong knowledge of regulatory requirements is required.
- Requires a high level of attention to detail and mental concentration, to ensure accuracy and total compliance with procedures at all times.
- Requires proven problem-solving skills and the ability to adapt to new requirements.
