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Validation Specialist

Validation Specialist

Job number: 27001229

  • Wrexham Branch
  • Permanent, Full Time
  • £55,000 per annum
  • + 33 days holiday (including bank holidays), Free parking, Professional development opportunities, Salary Sacrifice, Excellent Pension

Validation Specialist

Up to £55,000 per annum

Additional benefits:

• Stable employment in the current climate

• Excellent contributory pension

• 33 days holiday

• Salary sacrifice scheme

• Professional development opportunities

Permanent opportunity in Wrexham (Consultancy basis is available if preferred)

The Role:

We are delighted to be supporting a global manufacturer with their recruitment of a Validation Specialist. In this role you will be responsible for leading the execution and documentation of all validation activities surrounding sterile product manufacturing.

Responsibilities:

• Be responsible for the generation of accurate protocols and reports and ensuring that all work is performed within production time constraints.

• Act as Lead in the execution and documentation of a variety of validation activities.

• Be responsible for a variety of validation projects across departments - production, engineering, quality, and warehouse.

• Develop and write validation documentation, policies and procedures.

• Be responsible for writing and maintaining the computerised systems validation master plan and maintaining the site computerised systems inventory.

• Perform gap analysis of site data integrity against current standards and guidance.

• Support regulatory, corporate and internal audits by providing subject matter expertise in CSV, present audited validation packages and aid in the feedback to and resolution of regulatory observations.

• Work within the guidelines of cGMP and GAMP5.

The Candidate:

The successfully appointed Validation Specialist will have the following skills and abilities:

• Hold a Degree (or equivalent) in a Scientific or Engineering discipline.

• Extensive knowledge of cGMP and GAMP5.

• A background working in a similar role as a Validation Specialist (CSV)

• Demonstrable experience of pharmaceutical equipment and validation requirements.

• Demonstrable experience writing procedures in a manufacturing environment in line with GAMP5.

• Technical authorship skills to develop validation documentation, policies and procedures.

• High levels of numerical and analytical skills.

• Strong organisational and communication skills.

• Excellent attention to detail and good interpersonal skills.

• Good problem solving and solution providing ability.

• TrackWise software experience would be advantageous but not essential as full training will be provided.

The Package:

• Up to £55,000 per annum

• 33 days holiday

• 8.30am - 4.30pm Monday to Friday (with 30 minute lunch break)

• Excellent contributory pension

• Salary sacrifice scheme

• Professional development opportunities

The Company:

Our client is a successful manufacturing business operating in a specialist sector. The Validation Specialist is a job opportunity that has been brought to the market due to increased workload offering stable employment in today's current climate. The company prides itself in its positive work place culture as well as its reputation for learning and development.

Key skills or similar Job titles:

Test & Validation Manager, CSV Engineer, Scientific, Validation Engineer, CSV, Computer Systems Specialist

To Apply

This vacancy is advertised by Travail Employment Group who are acting as an Employment Agency.

Once you click to apply for this job your application will be immediately received by Travail Employment Group. If your application is successful a consultant will be in contact with you within the next 7 days. If you do not hear within the next 7 days you have not been successful on this occasion and unless otherwise advised, Travail will keep your details on file and contact you with future relevant opportunities.

All candidates registering with Travail Employment Group will need to provide proof of identity, and evidence of any experience, training and qualifications our client considers necessary for this position.

Travail Employment Group is acting as an Employment Agency in relation to this vacancy.


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