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  • Job reference: RMS0110089

Quality Assurance Officer

  • Sector: Engineering
  • Location: Billingham
  • Job type: Contract
  • Date posted: 06/06/2012
  • Time left:
    d h m s
    (13/06/12)
This vacancy has now expired.
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The Company:
One of the world's leading private biotechnology companies, developing and manufacturing innovative biotechnology-based medicines for human healthcare products, with a focus on microbial-derived biologics .

The Role:
REPORTS TO:
Vendor Assurance Manager

JOB PURPOSE
To operate, administer, maintain, develop and continuously improve the QA Vendor Assurance processes.

KEY TECHNIQUES
• Application of core QA procedures
• Proficient in the use of Microsoft Offices packages particularly Word, Excel & Access
• Team work, flexibility and good interpersonal skills

PRINCIPAL ACCOUNTABILITIES
1. Run, administer, maintain, and continuously improve the Vendor Assurance processes operated by QA.
2. Operate core QA events, deviation, non conformance, change control, and document writing and review processes as instructed by QA Management.
3. Ensure self has no overdue events, deviations, NCRs, training, change control, preventative or quality improvement actions.
4. Train staff in own and other areas as required in specific tasks related to job role.
5. Ensure local work processes are continuously improved and any efficiency gains are captured in work instructions or guidance notes.
6. Continuously improve the Safety, Health, and Environmental impacts of local work process operated by self.
7. Represent assigned QA systems and own work on quality records (Change controls, Batch Manufacturing Record, validation documentation etc.) in customer and regulatory audits.
8. Where appropriately trained be able to deputise for and carry out the duties of nominated QA personnel of similar or lower grade.

Essential Skills / Qualifications:
1. Minimum of one A level in a science based subjects or similar qualification or equivalent competence demonstrated by experience.
2. Minimum of 2 years work experience in a Good Manufacturing Practice (GMP) environment.
3. Expert in the administration of controlled spreadsheets.
4. Must be able to work effectively and accurately when balancing conflicting priorities or handling large amounts of information, data or documentation.
5. The job holder will be required to perform internal and external audits.
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