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CQV engineer


  North East,   £55-60 p/h

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  Engineering    Contract

Vacancy Details

My client, a leading UK biopharma are looking qualification engineers for a number of CAPEX projects.  

Title: Qualification Engineer

Salary: £50- 60 p/h

Location: North East

 

Responsibilities:

• Support quality aspects of qualification and validation of equipment, facilities, and utilities associated with manufacturing/warehousing to ensure compliance with company policies, procedures and regulatory expectations.

• Develop and execute protocols for the execution of commissioning and qualification activities. (DQ, FATs, SATs, Installation Verification, Functional Testing, IQ and OQ)

• Will serve as the Quality SME for validation activities on the project including but not limited to: Utility and equipment performance qualification & Cleaning Validation.

• Provide Quality oversight for any temperature mapping studies, for example, standalone TCU’s, Warehouse temperature controlled storage, Site Stability rooms.

• Input to Standard Operating Procedures (SOPs)

• Serve as a quality resource for assessing validation requirements, non-conformance, impact assessments, root cause analysis and implementation of CAPA found during CQV activities.

Work closely with stakeholders and SME’s from site operations, quality operations, engineering to provide quality oversight throughout the qualification and validation lifecycle.

• Use of Quality Risk Management and Operational Excellence to promote continuous improvement. Qualifications and Experience

 

• This role requires a minimum of 8 year’s experience in Quality Assurance, Technical Operations or Engineering within the Biopharma / Pharmaceutical industry.

Must have at least 5 years of experience in commissioning, qualification, and validation activities in in a regulated environment.

• Experience working in regulated environment with exposure in the Regulations & guidance’s – GMP, CGMP, GAMP, 21 CFR Part 11

• Technical knowledge of validation/verification, quality systems and regulatory requirements

Looking but this isn’t the right position for you?

If you are interested in a new opportunity but your experience doesn't fit this role, please email your CV to or call 0203 589 9282 for a confidential discussion about potential opportunities.

 

NOT OF INTEREST TO YOU BUT KNOW SOMEONE IT WOULD BE?

Catalyst Life Sciences offer a generous referral scheme reward, whereby anyone who refers us to a successfully placed candidate is entitled to up to £250 worth of vouchers.

Joe.Lane

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