Quality Assurance Lead Investigator

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Hours: 37.5 hours per week

Salary: Competitive

Ref No: HRJOB9570

Business Unit: Pharma Services

Location: Loughborough, Leicestershire

Open To: Internal and external candidates

Please note this is a re-advertisement, if you have applied for this position within the past 6 months, we will be unable to accept your application at this time

About The Role

The role of the Lead Investigator is to oversee and manage the timely investigation of deviations and CAPA’s. The successful candidate must ensure that investigations are performed and documented, with appropriate root cause determination and to ensure that CAPA actions are identified and implemented in line with procedural and regulatory expectations.

In addition, Lead Investigator will be aligned with operational areas and must work closely with the senior manager of that area to communicate, educate and ensure continuous improvement within those areas.

The successful candidate will be part of a Lead Investigator team working closely with Quality Assurance to manage and support investigations in all business areas.

About You

To be successful in this role, we’re looking for you to have:

· Degree (or equivalent) Qualification

· Note: significant relevant work experience and knowledge will be considered in lieu of degree

· GCSE English and Mathematics or equivalent (Grade C or above)

· Industry experience within a Pharmaceutical GMP environment

· Analytical approach with demonstrable capability in the processing of high volume technical information

· Excellent written and verbal communication with effective presentation skills

· Proven ability to make confident decisions based upon sound justification

· Proven ability to manage multiple tasks simultaneously whilst maintaining a high level of accuracy in all work carried out

· Forthcoming with ideas / suggestions and continuous improvement initiatives

The following criteria would also be beneficial to your application, but is not essential:

· Root Cause Analysis Training (Lean Six Sigma Qualification, 8D Problem Solving etc.)

· Previous experience within a role involving investigation, data analysis and narrative report compilation is preferred

· Knowledge on Root Cause Analysis technique

· Previous technical writing experience preferred

· Previous experience in supporting audits (customer and/or regulatory)

Reward

For the successful candidate, we offer an attractive benefits package which includes a competitive salary, a flexible hybrid working model with a degree of home working, annual bonus, employer pension contributions, 34 days paid annual leave, healthcare benefits and much more.

To Apply: Apply online by submitting a CV that details how you meet the essential and desirable criteria

Closing Date: Friday 3 May 2024 at 1700 hours

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