RT Lane Recruitment
Job title:
QA Specialist
Company
RT Lane Recruitment
Job description
QA Specialist urgently required for a busy Pharmaceutical Manufacturing site in Cork. Experience of Batch Record review, Projects and Operations. This role would suit someone with at least 3 years experience gained within a Pharmaceutical Operations environment.Duties
- Batch Record Review & material release.
- Carries out tasks related to the management of batch records design and approval.
- Carries out administration of the SAP Quality Management Module.
- Carries out tasks relating to the management of site change control systems.
- Compiles Annual Product Reviews.
- Supports all validation activities on site as described in the Site Validation Master Plan.
- Approves and compiles where appropriate validation protocols and reports (analytical, cleaning, computer, process, equipment, etc.)
- Supports system qualification and process validation activities.
- Reviews and approves SOPs/work instructions/forms from other departments on behalf of Quality Assurance
- Co-ordinates and assists in the preparation for regulatory and customer GMP inspections of the site.
- Participates in the introduction of new process or modified process steps, as part of a New Product Introduction Team (NPI
- Perform GMP audits on-site and vendor facilities as required
- Performs on the floor walkdowns regularly to ensure process and facilities are maintained to GMP standards
- Carries out tasks related to the administration of site supplier approval process.
ESSENTIAL- Quality Assurance Specialist-QA Operations:
- Bachelors Degree in a scientific/technical discipline require
- A minimum of 3-5 years’ experience in a quality, validation or compliance role within the biological and/or pharmaceutical industry
- Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals.
Expected salary
Location
Ireland
Job date
Tue, 08 Oct 2024 23:12:15 GMT
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