QA Manufacturing Compliance Specialist
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| Job Type | Contractor |
| Area | Sligo, Ireland |
| Sector | QualityOperations & ManufacturingEHS |
| Start Date | |
| Advertiser | Mary King |
| Job Ref | 1003129 |
| Job Views | 319 |
- Description
- Team Horizon is seeking a QA Manufacturing Compliance Specialist for our client based in Sligo. In this role the specialist will be responsible for ensuring that all products leaving the site meet the standards required for marketed and investigational drug products.
Why you should apply:
This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.
Our client is developing the capability to produce all its medicines, helping to ensure continuity of supply of our medicines as they expand internationally.
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 on site 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 / 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 Line Clearance activities.
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).
Finished product status maintenance, including labelling 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.
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.
Requires innovative thinking, where new and untested solutions are proposed, demonstrated and implemented on a regular basis.
Must be results driven striving to meet all targets and metric standards as set by site/department and division leaders.
