Incoming Quality Control Supervisor

Employer
Manpower Ireland
Location
Dublin, Clondalkin
Salary
bonus, health insurance, pension
Closing date
26 May 2022

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Sector
Scientific
Job Type
Permanent
Hours
Full-time
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Incoming Quality Control Supervisor

RESPONSBILITIES

  • Supervise and coordinate IQC Specialists and Analysts' daily schedule to ensure material is tested and released within the defined timeframe
  • Ensure the correct sampling and testing of raw materials in GMP classified Grade C/D clean room and non-classified GMP environments as required
  • Subject matter expert (SME) for IQC GMP classified Grade C/D clean room sampling cabin and related operational, sampling and testing procedures
  • Ensure correct sampling and testing of packaging materials in non-classified GMP environment as required
  • Ensure all required testing of raw materials and packaging materials is performed as per procedures
  • Ensure adherence to production plans
  • Ensure environmental monitoring of Cleanroom environment complete in compliance with GMP requirements
  • Ensure cleaning activities for the Incoming Quality Control sampling cabin complete as required and liaison with the responsible contractor
  • Ensure all Laboratory equipment is operated, maintained, calibrated and qualified as required in line with site procedures
  • Completion of quality Raw Material Specification documents and Quality review of other GWWO documentation as applicable
  • Creation, review and update of area specific SOPs to ensure all aspects of compliance are adhered to
  • Training of new Incoming Quality Control personnel when appropriate with specific responsibility for GMP clean room related sampling and testing activities.
  • Complete and drive process/product/OOS and deviation investigations related to Incoming Quality Control
  • Complete and drive Corrective and Preventative actions related to Incoming Quality Control
  • Support supplier complaints as required
  • Maintain and monitor Incoming Quality Control metrics and KPIs
  • Liaise with QC Chemistry teams to ensure raw materials samples are available for further processing in QC Chemistry and Microbiology as per the timelines
  • Interaction with cross functional departments within GWWO and Grifols sister sites
  • Support site quality activities, including but not limited to: Annual Product quality reviews, recall activities, change control etc.
  • Represent the Incoming Quality Control department in any internal, corporate or regulatory audits as required
  • Initiate and implement improvements in IQC processes
  • Keep abreast of the latest developments from regulatory authorities in relation to Quality Compliance activities
  • Support any projects impacting the Incoming Quality Control department such as Method Transfers, Process Improvement or Harmonization projects
  • Participate in international project teams relating to IQC and wider quality activities where travel maybe required
  • Act as a delegate for activities performed by the IQC Assistant Manager for IQC activities

KNOWLEDGE AND SKILLS

  • SME for GMP clean rooms used for raw material sampling and testing
  • Sampling and testing of incoming raw materials in a GMP cleanroom environment
  • Experience with raw material testing equipment including NIR
  • Experience in sampling and testing of packaging materials
  • Excellent verbal and written communication skills in English
  • Strong technical writing skills
  • Strong interpersonal skills with the ability to interact with all levels of personnel in a professional manner
  • Ability to handle multiple projects and deadlines
  • Demonstrated problem solving skills
  • Demonstrated project management skills
  • Strong Decision-Making skills
  • Method Transfer and qualification knowledge
  • Equipment Qualification Experience
  • Competence in Microsoft packages; specifically, Word, Excel and Powerpoint
  • SAP experience desirable

QUALIFICATIONS

  • BSC or equivalent in chemistry, biochemistry, pharmaceutical science or related field
  • Minimum 1 year supervisory/management experience in a quality or manufacturing setting
  • Minimum 2 years working in GMP clean room raw material sampling environment
  • Minimum 2 years' experience in testing/reviewing/releasing of packaging components

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