Planet Pharma is pleased to be recruiting for a QA Specialist to work for a leading organisation in the UK. This role is responsible for supporting the enrolment and maintenance of the global standards process, ensuring smooth implementation and management of critical documentation and quality systems. The successful candidate will play a key role in maintaining compliance, coordinating system implementation, and serving as a point of contact for stakeholders.
Key Responsibilities*
• To provide shoulder to shoulder review of documentation generated during manufacturing processes, development and laboratory processes.
• Advise areas of support on best practice for document completion, review and follow up actions/ escalate if required.
• Acting as a point of contact for general queries relating to Quality and escalating as required.
• Expand and utilize knowledge of quality procedures to identify and report non-conformances and resolve issues arising in the area via interaction with the relevant personnel.
• Utilize knowledge of GMP and quality processes within the functional areas to manage and escalate major and critical compliance issues through the site QMS processes e.g. deviations and CAPAs.
• To actively identify, suggest and participate in continuous improvement activities
• Mentor and coach business partners in cGMP practices to maintain and develop a cGMP environment.
• Maintain and promote a state of audit readiness.
• Actively suggest, initiate, participate and contribute to PQS process improvement initiatives and projects.
Qualifications
Education/Degree
Required* Bachelors of Science (or equivalent experience) Field of Study Biology or related field
Work Experience
Previous work experience in QA / GMP experience is useful though not essential
Additional Skills:
Risk based decision making
PQS experience
Accurate data entry skills, high attention to detail