Quality Control Lab Manager

Recruiter
Randstad In-House Services
Location
North West London
Salary
£30k - £40k pa + Pensions and Paid Holidays
Posted
15 Feb 2017
Closes
15 Mar 2017
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
Work for Randstad

You are a self starter who likes to complete a hard day's work like it's a child's play. You are a go getter who knows what they want and will do anything to achieve their target and goals within set time. You consider yourself to be pro-active who foresees adversities rather than reacting to adversities. You enjoy working as part of a group and can survive if left on an island too. A quick thinker and a decision maker who has set or plans to set many good examples of work ethics. You are dedicated and makes you best out of the rest. You are the kind of person we are looking to hire.

The Client

My client is a renowed Pharmaceutical company in the world and in the pharma industry based in Park Royal area in North West London. They are currently looking to recruit a Quality Control Lab Manager on a Temporary Assisgnment of upto 6 Months.

The Job
As part of the Quality team the Quality Control Lab Manager will work closely with the Quality Assurance Manager to maintain an understanding of the microbiological risks to the Aseptic Manufacturing process, how to mitigate and control these risks and to implement studies to support and enable best practice in contamination control and aseptic processing. The Quality Control Lab Manager must be familiar with the regulatory requirements specific to the micro laboratory. Below is a brief of the job.

Lab Manager duties

- Make recommendations for new equipment and methodology
- Ensures all reagents and supplies are available when needed.
- Liaise with external supplier regarding laboratory equipment and consumables
- Requesting quotes and placing orders
- Prepare monthly quality reports regarding EM
- To provide organistional expertise in Microbiology
- To provide the following training to the production staff: Basic Microbiology, Cross contamination, Cleanroom behaviour and cleaning and Disinfection practice
- To lead site complaince and remedial activities in microbiologically related areas
- To ensure suitable risk based decision making occurs relevant to EM data and presence of certain organisms
- To ensure best practice is followed to reduce clean room contamination
- To perform routine Environmental Monitoring duties within the cleanrooms and manufacturing areas.
- To perfom routine micro identification testing
- To perform microbiological valiation testing
- To prepare technical documentation within the department.
- To carry out and manage projects in the department as required.
- To develop and validate relevant cleanroom and manufacturing procedures within the department as and when required.
- To review microbiological and cleanroom and manufacturing area data for accuracy, completeness and compliance with documented procedures.
- To communicate effectively and proactively with others on site and participating with departmental and site wide problem solving as required.
- To ensure that all work carried out and documentation complies with departmental procedures and GMP.

- Organize proficiency test (internal and external)
- Maintain laboratory microorganism library (ATCC strains and in-house isolates)
- Perform and train QC staff in aseptic technique, micro identification tests and media QC
- Evaluates existing systems and processes and develops corrective action plans for service/quality trends identified Initiates changes and monitors for improvement
- Organize QC testing in the laboratory and schedule validation testing in production

- Ensures that QC laboratory proactively respond to production need
- Track validations exercise in the production
- Reviewing and approving test reports
- Issuing Green Light for production

Education

Degree or equivalent in Microbiology (required)

Previous Experience

Experience of working in a microbiology environment/laboratory

Understanding of challenges encountered in clean room contamination control

Demonstrable ability to assess risk and make decision on patient safety based on environmental monitoring data and investigation findings

Previous experience within a Pharmaceutical environment preferred

Good Understanding of GMP (clearly demonstrated by core knowledge and examples)

**Only apply with your upto date CV and a cover letter, if you meet the all of the above requirement.