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QA SPECIALIST - PROCESS SUPPORT

 

Company:

PHARM ENG LTD
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Job Reference Number

14563541

Client ID:

RI/PERFAD22
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Posted On:

Jan 30 2012

Location:

CARLOW
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Job Type:

Permanent

Salary:

EUR 55,000 - 60,000
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PharmEng requires a number of Quality Assurance Specialists on an hourly rate contract basis for one our client sites based in Carlow. The positions will be for 11 months initially.

  • Participate in Company process reviews as the Quality Assurance representative. Ensure that quality issues are identified, addressed and resolved before production commences.
  • Carry out the QA review and approval of postproduction process batch for validated steps prior to release of material by Quality. Provide positive feedback on re-occurring issues thus ensuring continuous improvement to the system. Carry out QA review and approval of the postproduction cleaning records for validation steps prior to release of material by Quality.
  • Provide support to deviation investigations and process performance monitoring on a daily basis.
  • Provide detailed knowledge of quality systems in place and ensure that root cause is identified and corrective actions as appropriate are completed. Identification of repeat a typicals or trends during the batch manufacturing process.
  • Attend cleaning meeting, review any cleaning investigations and ensure corrective actions are closed out. Review technical assessment and approve cleaning protocols.
  • Prepare & coordinate the review & approval of the Annual Product Review Schedule.
  • Prepare annual process reviews for intermediates and finished bulk products as determined by the Annual Product Review (APR) Schedule..
  • Review and verify Company documentation that may be used for submission to RAS-CMC or other requester(s) for regulatory submissions/filings. Assure the accuracy and integrity of all data and information through a timely review program.
  • Support the introduction of new products onto site in relation to Quality oversight, covering the end to end strategy.
  • Participate in the Product Core Team meetings and facilitate the Quality Sub Team meeting. Authors, reviews and participates in approvals of protocols and reports for technology transfer, method qualifications and method validation.
  • Performs quality reviews and approvals of engineering/validation/automation/utilities commissioning and qualification activities.
  • Act as lead auditor to support the internal GMP audit schedule including preparation & approval of the internal schedule and the external suppliers audit schedule.
  • Complete vendor audits as requested by the Divisional Audit group & aid in specific queries in relation to company related materials.
Education / Experience

  • 3-4 years experience working in a similar role within the pharmaceutical industry (biological background preferably)
  • Degree qualified (Science related field
Please send in your CV for the attention of Robert Carroll.