Job Description
Are you a quality-driven professional with a strong background in GMP compliance and operational excellence? Then this could be a great opportunity for you!
Our client is an international front runner in the pharmaceutical space, with decades of proven innovation across the globe. The are looking for an experienced Senior Quality Lead to be the sole person on site responsible to provide critical oversight and support for their manufacturing operations.
Key Responsibilities:
You will be working for a world-class leader in their field, and solely responsible for quality at your site. This includes leading all quality initiatives, setting standards and responsible for ensuring clean audits. A senior role with great responsibility. Being an international company and in a critical role there will be great exposure and opportunity for growth within the business globally. You will be part of a company with a greater purpose and where you can make a difference.
To apply directly you can email Natalie at natalie.lotter@enterprise.co.nz or contact Natalie for a confidential discussion on 04 568 0375.
Our client is an international front runner in the pharmaceutical space, with decades of proven innovation across the globe. The are looking for an experienced Senior Quality Lead to be the sole person on site responsible to provide critical oversight and support for their manufacturing operations.
Key Responsibilities:
- On-Floor Quality Support: Provide real-time quality assurance across manufacturing operations to uphold GMP standards.
- Batch Record Review & Approval: Ensure thorough review and approval of manufacturing and packaging batch records, maintaining oversight of quality investigations.
- Regulatory Compliance Management: Act as the primary contact for site compliance, including GMP certificate management and site readiness.
- Audit Preparation & Compliance Reporting: Report on site compliance, audit readiness, and track progress on audit findings in collaboration with global quality compliance functions.
- Leadership in Audits: Lead all internal, regulatory, and vendor audits for quality operations to foster a consistent and compliant operating environment.
- Continuous Improvement via Data Analysis: Develop and implement tracking and trending systems for audit and inspection data, ensuring timely corrective actions.
- CAPA Oversight & Inspection Results: Analyse inspections, GQCA audits, and other key documents, ensuring effective CAPA implementation.
- Change Control & Product Release Management: Oversee product release compliance and approve change control management processes to ensure regulatory standards.
- Environmental Monitoring & Documentation Oversight: Lead coordination of the site’s environmental monitoring program and manage the documentation system effectively.
- Customer Complaint Resolution: Conduct thorough assessments of customer complaints to ensure timely, effective resolution.
- BSC Degree is essential
- 5 years+ in quality assurance and quality management systems.
- Demonstrated experience in GMP compliance within manufacturing or quality operations. (pharmaceutical experience is preferred)
- Strong expertise in quality assurance, audit management, and regulatory compliance is essential
- Detail-oriented with advanced problem-solving skills and technical expertise.
- Excellent communication and leadership skills to work effectively with cross-functional teams.
You will be working for a world-class leader in their field, and solely responsible for quality at your site. This includes leading all quality initiatives, setting standards and responsible for ensuring clean audits. A senior role with great responsibility. Being an international company and in a critical role there will be great exposure and opportunity for growth within the business globally. You will be part of a company with a greater purpose and where you can make a difference.
To apply directly you can email Natalie at natalie.lotter@enterprise.co.nz or contact Natalie for a confidential discussion on 04 568 0375.