Senior Quality Operations Lead
1 month ago
Based in Wellington, New Zealand you will manage compliance, product release and minor regulatory activities on site.
**Key responsibilities.**
- Provide in plant/on floor support and guidance for GMP product quality assurance and compliance for Manufacturing Operations.
- Review and approve executed manufacturing and packaging batch records.
- Provide manufacturing and packaging operations Quality oversight.
- Review and approval of manufacturing and lab investigations and CAPAs.
- Responsible contact for site license registration process including transitional facility compliance and management of GMP certificates.
- Provide feedback to site and quality global compliance auditing function on states of site compliance, inspection readiness, and progress against previous audit findings.
- Consolidate site audit data for tracking/trending for compliance communications to GMS and global quality compliance & auditing function.
- Lead the QO internal or external regulatory audits and vendor audits.
- Provide technical expertise as requested and conduct business interactions in ways that reinforce and compliment Zoetis site quality assurance programs.
- Develop a process to track and trend internal audit and inspection data and the creation resultant action plans as necessary.
- Consolidate outcome of BOH inspections, GQCA audits, self-inspections, regulatory letters, manufacturing alerts and other relevant documents for the site, contractor or supplier to identify trend and ensure CAPA plan is implemented.
- Ensure regulatory compliance through change control management approvals.
- Ensure product release in compliance with registration file including raw material and printed material release.
- Coordination and oversight of the site environmental monitoring program.
- Management of the site documentation system.
- Complete assessments of customer complaints.
**Education and experience**
- Science Degree or equivalent qualification and experience in Quality Assurance and Quality Management Systems.
- Proven Organisation skills
- Presentation skills
- Ability to work with regulators effectively to achieve business outcomes
- Understanding of quality control testing
- A proven ability to analyse, assess and deliver results for a given issue
- A demonstrated ability to work effectively and credibly with all levels of the manufacturing organisation
- A sound understanding of GMP as well as corporate and regulatory quality standards
- An understanding of large scale manufacturing
- The successful applicant will need to be Covid 19 X 2 vaccinated and be prepared to have tetanus vaccination due to workplace conditions.
- This is an On-Site role - 5 days per week, due to operational nature of the work.
- Computer literacy in word processing, spreadsheet analysis, presentation software and database software
- Ability to navigate & operate virtual meetings in various platforms
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