Qualified Person

Location: 

Braunton, GB, EX33 2DL

Description Overview


 

We have an exciting opportunity for a Qualified Person to join the team based in Braunton, North Devon. This is really key role to support our business as we continue to progress and grow. 

The successful candidate will be required to work onsite 5 days per week. 

 

  • Demonstrate Quality leadership to the site and centralised functions, providing guidance and interpretation on cGMP.
  • Encourage collaborative/supportive working across functions.
  • Undertake QP certification, Technical Release, and Batch Release to Market.

Scope of the Role

  • Responsible for all batch release activities, ensuring they are completed within required timelines and in accordance with cGMP.
  •  Review and approval of quality documentation such as master batch records, audit reports, technical agreements, change control plans, customer complaints, qualification and validation protocols and reports.
  • Generation of QP Declarations.
  • Support client audits and regulatory inspections relating to Quality/Manufacturing activities.
  • Act as a Quality Department Subject Matter Expert by coaching/training personnel in the application and underlying rationale of GMP Principles
  • Build and maintain good working relationships with Operational teams and work with them to improve compliance and understanding.
  • Represent the department during audits and regulatory inspections
  • Approve deviations and ensure root cause is determined and robust corrective actions are identified.
  • Maintain up to date knowledge of the regulatory requirements for Quality/Manufacturing.
  • Support the co- ordination of recall simulations and recall activities.
  • Support internal and external escalation events and prepare associated risk assessment reports.
  • Undertake such other reasonable duties as may be required from time to time in order to support the Perrigo business.

 

Experience Required

  • Eligible to act as a Qualified Person in accordance with The Human Medicines Regulation 2012
  • Minimum of 10 years’ experience in a GMP industry.
  • Must be able to motivate others, self-manage, have excellent organisational and time management skills and respond appropriately to numerous requests and prioritise accordingly within tight deadlines.
  • Must be able to work flexibly in high pressure environments and be able to make defensible
  • decisions.
  • Experienced as a pharma quality professional with an in-depth understanding of a manufacturing site subject to a high degree of change.
  • Excellent interpersonal skills and experience of working with and influencing senior managers and customers.
  • Able to build and maintain effective relationships with key stakeholders across all areas of the business.
  • Effective communication skills – written and verbal – can convey information positively, succinctly, objectively.