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MSD Ireland

Aspectic QA Specialist Job

MSD Ireland

  • Carlow
  • Negotiable
  • Permanent full-time
  • Updated 01/02/2013
  • Merck
this job is expired
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Description

Aspectic QA Specialist Job

 

Aspectic QA Specialist-LAB000194

Description

The Aseptic Assurance Specialist (Senior Microbiologist) will carry out most of his/her duties in the EC Laboratory and the primary tasks and responsibilities of the position are as follows.

- Will report to the QA lead-IPT (Site Microbiologist)
- Act as Microbiology Subject Matter Expert for process simulations, risk assessments, microbiological method validations , biological indicators and aseptic assurance matters.
- Perform critical review of trend data, develop remediation plans, provide proactive guidance in ensuring microbiological control of the plant water and environmental monitoring systems including isolator technologies. Communication of trend results to site leadership and manufacturing personnel.
- Develop and deliver training on Aseptic Assurance
- Support the operations team on all aspects of aseptic manufacturing. Review and approval of validation documents
- Leading out of specification investigation
- Working as directed by QA Lead-IPT according to Company safety policies, cGMP and cGLP
- .Develop and support site environmental monitoring programs
- Develop and support site Process Simulation Programs

Qualifications

The successful applicant will possess the following knowledge, skills, qualifications and experience.

- A BSc in Microbiology or related subject
- At least 6 years experience working within a an Aseptic processing facility (IMB and FDA approved)
- Expertise in Aseptic Assurance and Process Simulations.
- A proven track record of effectively.working with a manufacturing sterile operations team to ensure best aseptic practices are implemented and improved.
- Ability to critically review analytical data. Possessing excellent attention to detail is a must.
- Ability to trouble shoot, identify microbiological issues and follow up with corrective actions.
- Experience of preparing for and participating in regulatory audits in particular IMB/FDA.

*LI-SW1

Job: Quality Operations

Job Title: Aspectic QA Specialist

Primary Location: EMEA-IE-Leinster-Carlow

Employee Status: Regular

Number of Openings: 1

External Job Board Posting: Ireland - IrishJobs.ie

To apply for this position please click here

Ref: LAB000194-en_US_1359158493
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MSD Ireland

MSD Ireland

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