Quality Control Supervisor

Recruiter
Grifols
Location
Dublin, Dublin West
Salary
Negotiable
Posted
26 Aug 2022
Closes
23 Sep 2022
Ref
QC Supv
Contact
Ann Marie Corcoran
Sector
Scientific
Job Type
Permanent
Hours
Full-time

Incoming Quality Control Supervisor

Incoming Quality Control Supervisor required for a new purification plant for the blood protein albumin at Grifols Worldwide Operations (GWWO).

This role offers a chance to work in a state of the art facility, in an innovative Biotechnology company with excellent career development opportunities and a clear and committed patient focus.

 

The successful candidate will be a demonstrated self-starter with a proactive, hands-on approach, possessing excellent interpersonal, decision-making, team work, and communication skills capable to deliver to tight and often multiple deadlines in a dynamic, challenging work environment.

 

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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