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Fastnet – The Talent Group

QA Specialist

Fastnet – The Talent Group

  • Cork
  • See description
  • Temporary full-time
  • Updated 03/01/2018
  • Therese Keohane
this job is expired
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Description

Contract QA Specialist required for Cork based API facility

 

Reporting to tech transfer QO Lead, the QA specialist will be responsible for all QA activities associated with the technical transfer of a number of new processes. These will include (but not limited to): Purchased material qualification, equipment C+Q support, documentation GMP review, QC, etc.

Responsibility:
* Product release including incorporation of Lean/Agile principles to ensure efficient documentation review, batch approval/release and labelling.
* Review and approval of quality related documentation including: master batch records, cleaning records, SOPs, change controls, LIRs, and quality actions ensuring adherence to cGMPs, regulatory filing and site procedures
* Ensure production equipment is inspected during cleaning and conduct swabbing, if required
* Be an active member of process teams with a focus on ensuring quality and cGMP compliance, effective deviation investigations and continuous improvement in all aspects of operations
* Lead and/or participate in X-Matrix projects
* Lead the compilation and approval of Annual Product Reviews as per Site Schedule.
* Lead/participate in internal audits to ensure that site maintains high standards and strong quality systems
* Preparation for and take part in external regulatory and corporate quality audits, as required.
* Provide training, support and advice to colleagues on-site to facilitate cGMP improvement and best practice.
* Support other Quality Systems, as required, including supplier management/qualification; equipment, process and cleaning validation and Site Quality Review Team.


Requirements
* BSc in Chemistry or equivalent.
* Thorough working knowledge of GMP's and regulatory expectations for manufacturing of APIs.
* Minimum of 1 year of experience working in Quality Assurance in the pharmaceutical manufacturing industry, across the main areas of responsibility of the role.
* The ideal candidate will be a self starter with the ability to work on their own initiative and within teams.
* Strong communication and organizational skills are important.
* Excellent ability to deliver results, with strong interpersonal and influencing skills.
* Ability to build relationships internally and externally.

Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.

Fastnet - The Talent Group
'Not Just Placers.........Partners'

The Life Science Specialists

Ref: JO-1712-63088_1513677627
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Fastnet – The Talent Group

Fastnet – The Talent Group

 

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