Are you a responsible, experienced QC Manager with a strong pharmaceutical background, hoping to make a difference and ensure microbiology QC excellence?
Our Western Canada client excels in producing very specialized healthcare and bio-protection products, meeting the demanding needs of the marketplace. Your input would be much appreciated.
ROLE AND RESPONSIBILITIES:
- All activities of the QC laboratory - staffing, testing of raw materials, products
- (R&D, in-process or release stage), environmental samples.
- SME on all nonclinical and clinical (GLP or GMP compliant) microbiological testing
- at all stages up to licensure.
- OOS. OOT, facility environmental and batch specific monitoring / testing.
- Hiring, training entire QC Microbiology staff, including analysts and contractors,
- allocating ample resources to projects.
- Create a system that will ensure continuous improvement.
- Meet required EHS standards.
- Ensure SQIPP ( Safety, Quality, Identity, Purity, or Potency) standards met.
- Review and approve unit procedures relating to testing, sampling, or related operations.
- Technical data for regulatory submissions; take part in audits and CAPA; validations.
- B.Sc. Microbiology or related plus 5 to 7 years' QC experience.
- Inclusive knowledge of GMPs and GLPs, and regulatory affairs.
- Management background, able to create and lead effective, cohesive team of scientists.
- Proven technical writer and communicator, able to analyze data and interpret results.
- leading to excellent, workable, sound study protocols and reports.
- Excellent leadership and interpersonal skills, able to lead teams and problem-solve effectively.
Reference ID: 2785
Job Type: Full-time
- Company events
- Dental care
- Extended health care
- On-site parking
- Paid time off
- Vision care
as required by Province
- How many years of lab management experience do you have?
- Do you require relocation?
- Are you familiar with GMP and GLP?
- Bachelor's Degree (required)
- Quality Control: 5 years (preferred)