Production Compliance Lead

In this role you will work as part of a manufacturing operations team. Your prime responsibility will be for production compliance activities which provide support for production shift teams and dispensary with investigations, deviation management, change control, process monitoring and trending and CAPA. In addition, the role supports process and production optimisation through the operational excellence (OP-EX) programme.

 

Key responsibilities include:

  • Support to new change requests to ensure that pre-implementation actions listed are planned-in, performed and closed as required
  • Ensuring internal and external audit actions to support production teams are completed in a timely manner
  • Auditing of routine reviews and training files to ensure compliance
  • Ensuring the Process operation adheres to cGMP compliance and procedures
  • To perform and /or direct formal investigations of non-routine events or deviations raised through the plant quality systems. Write up and implement appropriate corrective actions
  • Responsibility for spreadsheet data input for process monitoring and trending
  • Identification of production optimisation activities and support of their implementation
  • Assisting with the scheduling of workload requirements and coordinating the work of internal and contract personnel
  • Providing resource for and supporting new product and process implementation at the CAPP facilityQualifications
  • Minimum educational qualifications: first degree in life science or chemical science or significant relevant industry experienceKnowledge or previous experience of cGMP compliance, deviation management, change control, process improvement programmes
  • Self-motivated, able to work without supervision
  • Team player with good communication skills
  • Good attention to detail especially in written word

 

Challenges

 The candidate will be challenged with supporting the compliance aspects of complex of state of the art automated manufacturing processes that run on a 24/7 operational basis. Being able to work in a cGMP compliant manner to strict guidelines and procedures is essential, and requires attention to detail and the discipline to follow written instructions and to record data correctly and accurately.

 

Albumedix

Albumedix helps biopharmaceutical companies improve patient outcomes with a range of albumin-based products and technologies that facilitate the development of superior biotherapeutics.

Albumedix develops albumin-based products and technologies for advanced drug and vaccine formulation, extended drug half-life and improved drug delivery. Our products and technologies are used in clinical and marketed drugs and out-licensed to pharmaceutical and biotech companies worldwide. With over 25 years’ experience in the biopharmaceutical industry, we have the scientific, technical and regulatory expertise needed to support companies in moving faster to market with superior biotherapeutics. We also use this expertise to strengthen our own drug pipeline. Albumedix is a global company and a fully owned subsidiary of Novozymes.

 

Deadline: October 20th

 

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