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Job Details

Quality Control Lab Manager

Company: Hospira UK Ltd
Location: South Croydon
Reference: RH/QCLM/C/HOSP
Closing Date: 13 Mar 17
Type: Full Time
Salary (£): 40,000 - 60,000
Benefits: £30,000 - £45,000 per annum D.O.E. + Company benefits package

Job Summary:

About us Hospira, now a Pfizer company, is the world’s leading provider of injectable drugs and infusion technologies. Through its broad, integrated portfolio, Hospira is uniquely positioned to Advance Wellness™ by improving patient and caregiver safety while reducing healthcare costs. The company is headquartered in Lake Forest, Ill., and has approximately 14,000 employees. Learn more at www.hospira.com.

Requirements:

Quality Control Lab Manager

£30,000 - £45,000 per annum D.O.E. + Company benefits package

South Croydon, London

As the world leader in specialty generic injectable pharmaceuticals, Hospira, now a Pfizer company offers one of the broadest portfolios of generic acute-care and oncology injectables, as well as integrated infusion therapy and medication management solutions.

As part of the Quality team the Lab Manager will work closely with the Quality Assurance Manager to maintain an understanding of the microbiological risks to the 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.

The responsibilities of the Quality Control Lab Manager will include, but is not limited to:

  • Prepare monthly quality reports regarding EM
  • 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 responds to production needs
  • Track validation exercises in the production environment
  • Reviewing and approving test reports
  • To provide organisational 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 compliance 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 perform routine micro identification testing
  • To perform microbiological validation testing
  • To prepare technical documentation within the department.
  • 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.
  • Perform reviews of  production processes (to meet regulatory and customer requirements )
  • Drive corrective and preventive action implementation (where appropriate to job role)
  • Participation in preparation for audits
  • Communication of changes to quality standards (obtained from external sources)
  • Conduct (once trained) relevant internal audits as defined by the relevant schedules or as required
  • Own and support Change Controls (where appropriate to job role)
  • Provide support for validation activities (where appropriate to job role)

The Quality Control Lab Manager will have the below Skills / Experience:

  • Degree or equivalent in Microbiology
  • Experience of working in a microbiology environment/laboratory ideally within a Pharmaceutical setting
  • Lab management experience ideally with additional line/people management
  • Solid experience of Micro identification, API testing, plate reading & Environmental Monitoring
  • Good understanding of GMP
  • Previous experience within a Pharmaceutical environment preferred

To be considered for the Quality Control Lab Manager role, please click APPLY

 

Apply for this job: Quality Control Lab Manager

Contact Information:

Address:  Head Office
Horizon Honey Lane Hurley Maidenhead Bucks
SL6 6RJ
England
Tel:  +44 (0)1926 820 820
Fax:  +44 (0)1926 835 271
Website:  Visit Our Web Site

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