This role requires a Quality Assurance Specialist with experience in QA operations. The ideal candidate will have a degree in a scientific/technical discipline and a minimum of 3-5 years' experience in a quality, validation or compliance role within the biological and/or pharmaceutical industry.
Key Responsibilities:
* Batch Record Review & material release to ensure compliance with GMP requirements.
* Carries out tasks related to the administration of event management systems including Review & Approval of Event, Deviations, and Customer complaints.
* Carries out tasks related to the management of batch records design and approval.
* Carries out administration of the SAP Quality Management Module.
* Carries out tasks relating to the management of site change control systems.
* Compiles Annual Product Reviews.
* Supports all validation activities on site as described in the Site Validation Master Plan.
* Approves and compiles where appropriate validation protocols and reports (analytical, cleaning, computer, process, equipment, etc.).
* Supports system qualification and process validation activities.
* Reviews and approves SOPs/work instructions/forms from other departments on behalf of Quality Assurance
* Co-ordinates and assists in the preparation for regulatory and customer GMP inspections of the site.
* Participates in the introduction of new process or modified process steps, as part of a New Product Introduction Team (NPI)
* Perform GMP audits on-site and vendor facilities as required.
* Performs on the floor walkdowns regularly to ensure process and facilities are maintained to GMP standards.
* Carries out tasks related to the administration of site supplier approval process.
Requirements:
* Excellent interpersonal skills.
* Able to operate as part of a team is critical.
* Customer focus.
* Innovative.
* Excellent communication skills both written and verbal.
* Attention to detail.
* Good problem solving skills.
* Results and performance driven.
* Adaptable and flexible.
* Decision making.
About Us:
We are looking for a skilled Quality Assurance Specialist to join our team. If you have the necessary qualifications and experience, please submit your application.