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  • Job reference: RMS0162998

Quality Assurance (QA) Associate

  • Sector: Oil & Gas
  • Location: Billingham
  • Job type: Contract
  • Date posted: 30/12/2015
  • Time left:
    d h m s
    (06/01/16)
This vacancy has now expired.
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:
JOB PURPOSE

To operate, administer, maintain, develop and continuously improve the routine systems operated by the QA Department for example Document Control and Issue, Change Control, Investigations and Corrective & Preventative Actions (CAPA), Materials Assurance, Auditing, Qualification and Validation, Manufacturing and QC documentation review and Training.

KEY TECHNIQUES
• Principles and application of Good Manufacturing Practice (GMP)
• Team work, flexibility and good interpersonal skills
• Auditing
• Coaching
• Sound judgement in Quality issues

PRINCIPAL ACCOUNTABILITIES

1. Administer, maintain, and continuously improve any assigned QA systems, which may include, Document Control and Issue, Change Control, Events Deviations & Non
Conformances, CAPA’s, Qualification and Validation, Materials Assurance, Auditing and Training.
2. Operate core QA events
3. Document writing and review processes as instructed by QA Management.
4. Ensure self has no overdue training, or site actions.
5. Train staff in own and other areas as required in specific tasks related to job role.
6. Ensure local work processes are continuously improved and any efficiency gains are captured in work instructions or guidance notes.
7. Continuously improve the Safety, Health, and Environmental impacts of local work process operated by self and team.
8. Represent own work on quality records (Change controls, Batch Manufacturing Record, validation documentation etc.) in customer audits as required
9. Where appropriately trained be able to deputise for and carry out the duties of nominated QA personnel of similar grade.

SPECIAL FEATURES


1. Minimum of one A level in a science based subjects or similar qualification or equivalent competence demonstrated by experience.
2. Must be able to work effectively and accurately when balancing conflicting priorities or handling large amounts of information, data or documentation.
3. Be able to identify when escalation to management is required with regard to conflicts in work or problems are identified.
4. Must be a flexible, self starting team player, able to work with minimum supervision, who possesses good organisational, time management and interpersonal skills and is
able to deliver high quality and accurate work.
5 Support the team in the delivery of all Business Programmes as required.
6 Build and maintain good working relationships with relevant departments and personnel as required. Ensure that all relevant documentation is made available.
7 Responsible for the review of data to support customers regulatory submissions.
8 Support QA manager in development and maintenance of systems within the QA department.
9 Actively participate in continuous improvement.
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