CPL, in conjunction with our client Pfizer, require a Quality Assurance Team Leader, to join the Quality Operations Team at Pfizer, Little Island, Cork.
The Little Island plant operates within API. Experience in API is ideal with management experience neccessary.
Your key responsibilities:
- Ensure all quality systems (Validation, internal audits, change control, Ancillary components, deviations and supplier management) are implemented/ executed in compliance with ICH Q7 and PQS
- Oversight of product manufacture, testing and release
- Approve GMP related documentation including batch records, validation protocols, procedures and specifications.
- Ensure that all manufacturing batch records are audited, that GMP issues raised are highlighted and addressed.
- Manage the non-conformance reporting system. Approve disposition of product for which non-conformance’s are reported. Propose and co-ordinate agreed corrective action measures to prevent re-occurrence of such problems.
- Ensure all customer complaints are investigated, appropriate corrective and preventative actions are identified to prevent re-occurrence and communicate the findings in writing to the customers.
- Ensure that there is a system in place to perform periodic audits and inspections of plant, equipment, records and procedures to ensure compliance with established standards of Good Manufacturing Practice. Report an all audits to relevant management personnel. Co-ordinate actions to eliminate and prevent unacceptable practices and procedures.
- Review and approve validation protocols for process validation.
- Ensure all Annual Product Reviews are completed on time
- Represent the facility and the Quality Assurance function in audits by external customers or regulatory authorities.
- Determine and organize resources required to implement Quality Assurance activities within the facility.
- BSc in Chemistry or related field/MSc, MBA or Ph.D. in Pharmaceutical related field preferable
- Experience of API manufacturing operations.
- 5+ years experience in Quality Assurance, Quality Control or a related compliance discipline
- This position calls for excellent technical, organisational, communication and leadership skills, and requires the Quality Assurance Team Leader to perform with confidence in what will be a consistently dynamic environment