Incoming Quality Control Supervisor
- Employer
- Manpower Ireland
- Location
- Dublin, Clondalkin
- Salary
- bonus, health insurance, pension
- Closing date
- 26 May 2022
View more
- 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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