Validation Support Specialist

4 months ago

Chapeltown, United Kingdom Consult Search Full time

**Validation Support Specialist - Steriles**

**Remote working with site visits to Sheffield**

**Initial 6 months contract - part time/ad hoc basis**

**Day Rate Dependent on experience**

**Scope**:
My client is a global leading provider and manufacturer of healthcare solutions. Due to upcoming changes in legislation and growth of the team, they have an immediate start contract opportunity within the QA team to join them on an initial 6-9 month contract.

Working within the Aseptic Unit Quality Department you will provide support for all aspects of process validation and qualification. You will work across Production, Quality and Regulatory departments to ensure that the unit remains compliant against the latest MHRA regulations relating to validation.

**Responsibilities**:

- Act as lead for co-ordination of validation activities relating to recent updated regulatory guidelines for the Aseptic Cleanroom suite
- Performing review and appraisals of existing validation documentation
- Generation of protocols
- Support and advise the Validation Technician as required

**About You**:
The following qualifications and experience are essential:

- Working knowledge of formal validation and qualification processes
- Ability to generate technical protocols and reports to a high standard suitable for regulatory scrutiny
- Recent knowledge of working within a GMP environment
- Knowledge of cleanroom aseptic manufacturing,
- Able to work alone on own initiative and as part of a team as required

It would be highly preferred to be familiar with MHRA Audits and ICH Annex 1. Unit qualification within a cleanroom (such as smoke studies and airflows) would also be highly advantageous.

IndScientific123

**Job Types**: Temporary contract, Freelance
Contract length: 6 months

**Benefits**:

- Work from home

Schedule:

- Monday to Friday

Work Location: Hybrid remote in Chapeltown

Reference ID: 1608SK

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