Senior QAV Specialist
This vacancy has now expired
Dublin is a hive of activity for the Life Sciences Industry at present with global Life Sciences organisations investing heavily in new facilities here.
One of the large Bio-Pharmaceutical manufacturing sites requires a senior QAV Specialist to join them on a 12 month contract.
Flexibility to combine remote working with on-site activities.
Responsible for delivery of quality assurance activities at the company's Dublin location to ensure products are introduced and manufactured in accordance with cGMP, Corporate and Regulatory requirements.
The ideal candidate will have the following experience / be able to perform the following tasks:
- Strong knowledge of cGMP requirements for pharmaceutical manufacturing and/or packaging required.
- Experience of sterility assurance for drug products and in manufacturing processes for pharmaceutical products and processes strongly desirable.
- Direct experience of GMP management within a pharma/biopharma company is essential, and will include exposure to FDA, HPRA/EMA or other authorities of similar standing.
- Experience providing quality oversight of validation activities through the review and approval of validation documents for equipment, software and equipment qualifications, and others.
- Review / Approval of Validation Protocols and Reports (e.g. URS, Facility, Utility, IT Systems, Test Method, and Equipment validations) to ensure compliance with current regulatory expectations, EU, FDA and Corporate Standards and Internal Procedures
- Quality oversight on operations and technical services to review and approve Process descriptions, sampling plans, operational procedures, Master production batch records process validation and cleaning validation documents .
- Investigation and approval of deviations generated encountered during qualification/validation testing.
- Participation in the change control program and deviations for modifications to new and existing equipment.
- Implement, deploy and revise as applicable Quality Validation procedures.
- Provide support for deviation investigations, including root cause analysis, and corrective & preventative action (CAPAs) proposals and initiatives.
- Support audit readiness activities and regulatory agency and internal audits.
The candidate must have the rights to work in the location stated in the job advert.
Please note, Quanta part of QCS Staffing does not sponsor Visa applications.
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