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Quality Assurance Compliance Specialist
Industry specialist
Owen Clancy
Recruitment Consultant
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Contract
We are currently recruiting for a Quality Assurance Compliance Specialist to join our clients Biologics site. The QA Specialist will be responsible for ensuring all manufactured products meet regulatory and company standards, with a focus on aseptic processes and compliance. Key duties include providing quality oversight during manufacturing, reviewing and auditing batch records, supporting investigations of non-compliance, and maintaining product status and quality documentation.
Responsibilities
Requirements
For a confidential conversation about the role contact Owen Clancy at +353 86 060 2922 or oclancy@sterlingengineeringeu.com
By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose
Responsibilities
- 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.
- 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
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.
For a confidential conversation about the role contact Owen Clancy at +353 86 060 2922 or oclancy@sterlingengineeringeu.com
By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose