Senior Quality Operations Lead

7 hours ago

Wellington, New Zealand This Is An It Support Group Full time

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 complement Zoetis site quality assurance programs.Develop a process to track and trend internal audit and inspection data and the creation of resultant action plans as necessary.Consolidate outcomes of BOH inspections, GQCA audits, self-inspections, regulatory letters, manufacturing alerts, and other relevant documents for the site, contractor, or supplier to identify trends 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 organizational skills.Presentation skills.Ability to work with regulators effectively to achieve business outcomes.Understanding of quality control testing.A proven ability to analyze, assess, and deliver results for a given issue.A demonstrated ability to work effectively and credibly with all levels of the manufacturing organization.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 vaccinated (2 doses) and be prepared to have a tetanus vaccination due to workplace conditions.This is an on-site role – 5 days per week, due to the operational nature of the work.Computer literacy in word processing, spreadsheet analysis, presentation software, and database software.Ability to navigate & operate virtual meetings on various platforms.
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