This is a Fixed term Contract for 10 Months
Duties and Responsibilities
The duties include the following. Other duties may be requested from time to time depending on the needs of the business or the Department Manager (or designee).
- Manages the day-to-day QA responsibilities within Production.
- Primary point of contact for quality assurance and production personnel regarding product quality and compliance issues.
- Responsible for the Issuance, reconciliation and release of batch records to Production based on production plan.
- Responsible for the QA activities for the release of product to inventory.
- Collaborate with cross-functional teams to ensure quality throughout the process from incoming inspection to the release of product to the customer.
- Liaise with Production coordinators, Production Planner and Warehouse supervisor to resolve issues relating to the production and/or shipments.
- Responsible for ensuring production are compliant with requirements and standards
- Escalate issues to QA Manager where necessary
- Quality lead for production NC’s and CAPA’s, facilitates root cause investigations.
- Trained internal auditor an advantage
- Preparation of monthly metric on a rotation basis.
- Responsible for the investigation of customer complaints related to the production process.
- Responsible for Continuous improvement for the QA department.
- Implementation of lean initiatives
- Other duties as assigned by the Quality Unit Manager
Qualifications (Education, Certification, Experience)
- Bachelor’s Degree in a Science Related Discipline preferred
- Trained internal auditor is an advantage
- 1 – 2 years’ experience in a regulated environment required
- 1 - 2 years’ experience in a similar role required
- Previous GMP experience required
Competency Assessment
- Good knowledge of current regulatory requirements
- Working knowledge of ISO 9001:2015 is requried, EXCiPACT and IPEC regulations an advantage.
- Experience working with a paper-based quality management system is an advantage.
- Strong attention to detail, focused on delivery of a Quality product.
- Good organizational skills with the ability to prioritize, demonstrate agility and adjust well to changes.
- Strong interpersonal and communication skills, ability to maintain a positive, Quality focused relation with internal and external stakeholders.
- Strong problem solving and conflict resolution skills
- Demonstrate Company core values of agility, collaboration, commitment, discipline, honesty, innovation, integrity, open to change, respect and responsible in all activities :