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QA /Regulatory Affairs (pharmaceutical)

South West   •  Competitive  •  Permanent, Full time


This is an opportunity to work for a well establish company in the Southampton area. The position involves assisting technical team and taking responsibility 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

Successful candidate will have BSc in Microbiology, Biochemistry or related discipline with 2-4 years’ experience as a QA /Regulatory affairs scientist in a pharmaceutical/ medical devices manufacturing or similar 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 position offers an excellent salary and above all, the ability to work with a highly successful team.

Candidates must have excellent communication skills as they will be expected to liaise with staff at all levels.

To apply for this position, candidates must be eligible to live and work in the UK

Key Skills: GMP, QA, HACP, CAPA, Management, Compliance, Auditing, Regulatory Affairs


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

  • Agency: ST Recruitment
  • Contact: Sam
  • Phone: 01737 241823
  • Reference: BWS20-
  • Posted: 16th April 2019
  • Expires: 14th May 2019

ST Recruitment

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