Company Profile:
Our client a leading biopharmaceutical company are hiring for a QA Compliance Specialist III for their state of the art manufacturing facility in Sligo on an initial 12-month contract. If interested in taking your next step into a Senior level QA role in a emerging pharma hub don't hesitate to reach out to myself today for more info or apply below.
Job Summary:
Ensure that all products leaving 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.
Key Responsibilities:
- 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
Essential Requirements
- Third level degree in a science, quality or engineering discipline.
- Ideally previous experience in a quality role
- 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. Cognitive Skills
- Requires a high level of attention to detail and mental concentration, to ensure accuracy and total compliance with procedures at all times.
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