Title: Supply Quality Officer
The Supply Quality Officer will be responsible for supervising external sites and materials that are used on site. The role holder will ensure that external site activities are meeting the product QTA/Marketing Application. The Supply Quality Officer will also certify that the materials used on site meet the GMP requirements.
Responsibilities (include but not limited to):
- Main Quality point of contact related to product at external site.
- Manage external sites contractual obligations in relation to the following: Quality Agreement, specifications, quality, safety, and regulatory requirements.
- Review completed production batch records, deviations, master batch records, change controls, audits/inspection responses.
- Understand and interpret GMP regulations concerning manufacturing and testing activities at external site and use of materials.
- Supply quality oversight of the manufacturing, testing and release of products at the external site.
- Write and drive actionable inspection of readiness plans.
- Identify and alleviate risk at the external site.
- Monitor and communicate site performance in relation to quality metrics through periodic and operating reviews.
- Work alongside Quality team and cross functional team to evaluate supplier performance.
- Facilitate review of supplier changes.
- Support maintenance of Approved Supplier List
- Escalate risks or barriers to management. Navigate Continuous Improvements.
Qualifications and Experience:
- Bachelor/Master's degree in science.
- A team player
- Compliance with all policies, procedures, ethical standards, and processes.
- Collaborate with all departments and external suppliers to resolve any issues.
- Ability to manage multiples projects simultaneously.
- Strong technical writing skills
- Excellent organisation and time management skills.
- Ability to collaborate effectively with both internal and external stakeholders.
- Excellent written, verbal communication and interpersonal skills.
- Capacity to work in a fast-paced environment.
Kelly Services are acting as an Employment Agency in relation to this role. Should you choose to apply, your information will be processed in accordance with Kelly's Privacy Statement. For information regarding data protection at Kelly, please visit the Kelly website and have a look into the Privacy Statement.
As an Equal Opportunities employer we welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age.