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Senior Quality Officer - Contractor

Salary:
43,015 P.A. ?
Location:
Tir-Y-Berth
Company:
Norgine

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MAIN PURPOSE:

To maintain, support and improve the Quality Management System at Hengoed, whilst maintaining compliance with regulations and standards for medicinal product and medical devices. To manage and perform internal and external audits for commercial products and processes and to review investigations related to product quality complaints. To support the QP in the execution of their legal and routine duties, and to maintain key quality documents in line with Global Quality objectives.

KEY DUTIES & RESPONSIBILITIES:

  • To provide leadership and direction aligned with M&S objectives and overall Norgine business strategy;
  • To manage the process, assist and facilitate the identification, assessment, investigation and reporting of quality incidents;
  • To manage the process, assist and facilitate the assessment and effectiveness of aspects of the QMS;
  • To provide advice and training on all quality related matters, including GMP, ISO standards, validation, and auditing;
  • To develop and maintain an overview of quality compliance through the effective use of key indicators;
  • To review and approve quality related documents for the site, including batch review in support of the certification process;
  • To support and facilitate internal and external inspections;
  • To report quality related KPI’s to the site and globally;
  • To lead, participate and support projects to enable continuous improvements;
  • To develop and prepare quality related documentation, including the SMF, GMP training, monthly and quarterly reports.

INDIVIDUAL REQUIREMENTS:

  • A degree or equivalent in a scientific subject is required.
  • A minimum of 5 years relevant experience in a Quality environment in the pharmaceutical industry.
  • In depth working knowledge of Quality Management Systems, cGMP, regulatory requirements and appropriate ISO standards is essential.
  • Project management and project leadership experience, well developed planning skills with ability to meet deadlines.
  • Excellent verbal and written communication skills, including the ability to communicate persuasively.
  • Able to demonstrate auditing experience, both internal and external.
  • Excellent teamwork within and across M&S and all other Business Units.
  • Ability to work and lead successfully in a matrix organisation.
  • Ability to influence and challenge.
  • Must be able to demonstrate strong communication skills at all levels, using different methods and techniques ranging from written reports to formal presentations.
  • Must be able to form and maintain relationships at all levels, within and external to the business, effectively conveying potential quality issues and offering constructive advice when needed.
  • Able to demonstrate clear thinking and sound decision making when advising on appropriate actions following a Quality Incident and agreeing necessary Corrective or Preventative actions.

BEHAVIOURS:

  • Must be able to demonstrate strong communication skills at all levels, using different methods and techniques ranging from written reports to formal presentations.
  • Must be able to form and maintain relationships at all levels, within and external to the business, effectively conveying potential quality issues and offering constructive advice when needed.
  • Able to demonstrate clear thinking and sound decision making when advising on appropriate actions following a Quality Incident and agreeing necessary Corrective or Preventative actions.


Requirements


  • A degree or equivalent in a science or engineering subject is required
  • A minimum of 5 years relevant experience in Quality environment in the pharmaceutical industry.
  • Line management experience.
  • Strong communication and supervisory skills are essential.
  • The ability to introduce, co-ordinate, complete and report on projects.
  • A high level of self-motivation is necessary.
  • Attention to detail
  • Able to rationally persuade
  • Influencing skills
  • Ability to perform audits, internally and externally

Benefits

£40 per hour contractor basis only. Anticipated end date 31st March 2020

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