Job Title: QA Specialist supporting Packaging and Engineering.
This role requires the experience and expertise in the quality support of multiple Packaging and Packaging Engineering activities while working on projects including the review and approval of associated validation documentation from the perspective of quality. The successful candidate will be required to exercise judgement to determine appropriate action with minimal supervision. Proficiency in the application of QA principals, concepts, industry practices and standards with specific emphasis on packaging, engineering and validation requirements.
Performs a wide variety of activities to ensure compliance with applicable regulatory requirements through quality support of Packaging and Engineering functions.
Works directly with Packaging and Engineering functions to ensure that inspections, statistical process control analyses and audits are conducted on a continuing basis as specified to enforce requirements and meet specifications.
Performs QA Review and approval on routine Packaging and Engineering documents including tech trial protocols and reports.
Involvement in investigations and corrective and preventive action (CAPA) recommendations related to packaged products.
Reviews and evaluates proposed changes, qualification and validation documentation as related to engineering and packaging.
Involvement with secondary packaging contract organisation, performing QA review and approval of associated documents, i.e. complaints, packaging instructions, change controls.
Participates in developing Standard Operating Procedures and writes and/or implements changes to controlled documents to ensure quality objectives are met.
Knowledge and Skills:
- Demonstrates proficiency in Good Manufacturing Practices (GMPs).
* Demonstrates proficiency in application of QA principles, concepts, industry practices and standards with specific emphasis on validation and packaging requirements.
* Previous experience with Change Management, Validation and Commissioning Documentation requirements is highly desirable.
* Demonstrates thorough knowledge of FDA / EMEA standards and quality systems, and the interface with other functions like packaging and engineering.
* Demonstrates strong knowledge of Six Sigma, Lean and root cause analysis tools used for identifying and correcting deviations.
Typical Education and Experience:
* 6+ years of relevant experience in a GMP environment related field and a BS or BA.
* 4+ years of relevant experience and a MS.
* Prior experience in pharmaceutical industry is preferred.
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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.