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Validation Manager posted by Torque Consulting

Full-Time
Brighton, Brighton and Hove
£45,000 - £50,000 / year

Job Description

Validation Manager - 45-50k

Torque Consulting are currently seeking a Validation Manager to join a growing global client of ours based in West Sussex.

Our client requires a candidate that can :

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Develop and maintain validation policies, standards and procedures defining a risk-based approach to validation and operational compliance

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Generate and report metrics to monitor the performance of the validation system

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Maintain & disseminate current knowledge of regulatory requirements and industry best practice pertaining to validation

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Develop validation knowledge & skills throughout the company to ensure all personnel can fulfil their defined roles & responsibilities effectively

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Lead validation planning with cross functional teams to ensure that an appropriate risk-based approach is taken and then execute

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Essential

1.

Degree, equivalent qualification or equivalent experience in a science or engineering background.

*

• Experience in a validation role within a GMP regulated industry, to include

process/equipment/cleaning/sterilisation validation
• Experience with Quality System concepts, practices, and procedures (e.g. ISO:13485, CFR820)

Working knowledge of cGMP, FDA 21 CFR Part 820 QSR and ISO 13485 Medical Device Quality Management Systems.

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Experience of validation, quality and change control management within a medical device / GMP regulated industry.

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Experience of successfully presenting to FDA Inspectors, Notified Body auditors and other regulatory functions.

*

Familiarity with statistical sampling techniques.

2.

Desirable

• Degree, equivalent qualification or equivalent experience in a science or engineering background.
• Experience in a validation role within a GMP regulated industry, to include

process/equipment/cleaning/sterilisation validation
• Experience with Quality System concepts, practices, and procedures (e.g. ISO:13485, CFR820)

If you believe you are interested please apply below

Reference Number

212599789

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