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Job Details

Validation Specialist / Validation / Medical Devices / ISO 13485 / IQ / PQ / OQ

Company: X4 Group
Location: Kent
Reference: JL1411
Closing Date: 12 Dec 16
Type: Permanent
Salary (£): 40,000 - 60,000
Benefits:

Job Summary:

Job Title:  Validation Specialist Location:  KentSalary: £35,000 - £45,000 (Depending on Experience)I am currently working with a Medical Device company based in Kent who are looking for a Validation Specialist to join their Quality Assurance team.The ideal candidate will be an individual who is able to recommend and design IQ/OQ/PQ and validation strategies as well as develop, prepare and write the protocols for validation activities, IQ/OQ and performance qualification. ...

Requirements:

Job Title:  Validation Specialist


Location:  Kent

Salary: £35,000 - £45,000 (Depending on Experience)

I am currently working with a Medical Device company based in Kent who are looking for a Validation Specialist to join their Quality Assurance team.

The ideal candidate will be an individual who is able to recommend and design IQ/OQ/PQ and validation strategies as well as develop, prepare and write the protocols for validation activities, IQ/OQ and performance qualification. Initiate and co-ordinate validation studies throughout the facility. Interact with all levels of management and staff to manage and facilitate the validation process from inception to completion. Interface extensively with Production and Technical departments to support projects and problems requiring validation support. Monitor and support the execution of the protocols through training, facilitating and problem solving activities. Write validation final reports that present, summarize and offer conclusions on the validity of the activity based on the results of the analysis. Ensure accuracy and integrity of protocols, reports and documentation generated to meet regulatory authorities.

The ideal candidate will be educated to HNC level or equivalent in a scientific or engineering discipline.

The main experience and knowledge his role requires is:

  • Experience of application of validation in a biomedical setting
  • Experience of software validation would be desirable but not essential
  • Extensive knowledge of ISO9001 and ISO13485 with regards to validation
  • Prior experience of FDA CFR 21 Part 820 (Quality System Regulation) would be beneficial
  • Good knowledge of Excel and statistical packages

The main skills/ abilities and qualities required are:

  • Be able to interact with personnel at all levels within company and external contacts such as audits
  • Be able to troubleshoot
  • Good interpersonal and communication skills
  • Good verbal and written skills
  • Good attention to detail
  • Good problem solving skills

If this is something that you or someone you know, would be interested in and have the necessary qualifications, then apply online and give me a call on 0207 812 7700.

Key Skills: Validation Specialist / Validation / Medical Devices / ISO 13485 / IQ / PQ / OQ 

Apply for this job: Validation Specialist / Validation / Medical Devices / ISO 13485 / IQ / PQ / OQ

Contact Information:

Address:  Head Office
2nd Floor, Brettenham House
Lancaster Place,
London,
WC2E 7EN
England
Tel:  02078127700
Website:  Visit Our Web Site

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