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QA / Regulatory Affairs Officer

South West   •  Competitive  •  Permanent, Full time


Description:

This is an opportunity to work for a well establish company near the Swindon area.

The QA / Regulatory Affairs Officer is responsible for activities related to product release, Quality Investigations, Auditing, Change Control, Customer Complaints, CAPA and Raw Materials, Component Release and Regulatory affairs.

Duties:

  • Improve Quality Systems and the speed and efficiency of the processes for delivering technical information.
  • Responsible for a compliant internal and external audit system and timely completion of audits.
  • Ensure effective coordination, risk assessments and implementation of change controls and focusing on continuous Improvement.
  • Review and proactively assist in process capability studies and statistical techniques, as necessary.
  • Ensure all company rules, regulations, HACCP plans, Quality Plan, procedure sheets and work instructions are implemented in full with particular reference to the following:- Supplier Approval; Raw Material Approval; Labelling; Equipment Calibration; Customer Complaint Analysis and Management, etc.

Qualifications:

The successful candidate will have BSc in Chemistry, Biochemistry or related discipline with several years’ experience as a QA /Regulatory affairs scientist in a pharmaceutical/ medical devices manufacturing or related industries.

Proven track record of working in a GMP/GLP environment and able to demonstrate knowledge of document control systems and auditing processes and MHRA, FDA regulations.

The successful candidate will have:

Strong verbal & written communication skills and also, good understanding of quality in a business context.

Good presentation technique and able to work to deadlines & attention to detail.

Skills: Good knowledge and/ or experience of both ISO 13485 and European medical device requirements

All applicants must be eligible to live and work in the UK.


You must be eligible to work in the UK. Learn more

  • Agency: ST Recruitment
  • Contact: Sam
  • Phone: 01737 241823
  • Reference: BRF-20
  • Updated: 21st December 2020
  • Expires: 11th February 2021

ST Recruitment

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