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  • 2 weeks ago

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Quality Assurance Manager

Dalton Pharma Services is a leading provider of integrated pharmaceutical discovery, development and manufacturing services to the biotechnology and pharmaceutical industries. We develop and manufacture innovative new products on a contract basis for our customers that bring enhanced therapeutic value and impact the lives of the patients that use them. Our customers range from the largest global pharmaceutical companies in the world to the smallest startup company. Dalton offers industry leading expertise in chemical synthesis, API production, formulation development and the manufacturing of sterile injectable products, all supported by extensive in-house analytical and quality teams.

The Quality Assurance Manager, reporting to the Director of Quality, will be responsible for managing all quality activities at Dalton to ensure cGMP regulations and internal processes are followed, ensure that incoming materials and products are release as per specifications... and to provide guidance and support to facilities, manufacturing, and analytical/microbiology laboratories.

The successful candidate should meet the following qualifications and requirements.

Experience Required
• Ensure GMP operations follow regulations and best practices by performing spot checks and aseptic training on Annex 1: Manufacture of Sterile Medicinal Products guidelines are implemented and followed.
• Extensive experience in managing and conducting and/or reviewing deviation investigations, developing and/or assessing CAPAs and implementing them via a change control program.
• Direct experience hosting and supporting client and regulatory audits (Health Canada, FDA and EU). Facilitating the responses to the observations arising from these audits and managing the follow up and closure of the corrective actions.
• Oversight of the issuance of batch records, worksheets, logbooks, labels and other documents to the manufacturing floor.
• Leading a team of QA professionals in the timely review of documents for incoming materials and components, in-process testing and finished products.
• Perform review and issuance of CoA for finished products.
• Support the review and approval of operational Standard Operating Procedures (SOPs) and associated change controls.
• Perform risk assessments to support operations and in particular, as they relate to sterility assurance.
• Review and approve validation protocols.
• Attend production planning meetings and provide status updates.
• Interface with clients to discuss and resolve quality issues as per the approved Quality Agreements.
• Revise and implement new policies and procedures to align with changing regulations (Health Canada, FDA, EU)
• Establishing a strong QA presence in the organization by working closely with the other functional teams to demonstrate a proactive approach to first time quality.
• Managing a team of professional(s) including performance management, succession planning (coach and develop employees) and distribution of workload.

Qualifications and Skills
• A minimum Bachelor’s university degree in a science discipline. Preference will be given to candidates with a Microbiology Degree, or at minimum, with university microbiology courses as part of the degree requirements.
• Experience working in an aseptic manufacturing environment is a MUST.
• 5+ years of experience as a Quality Manager, responsible for leading a team of Quality personnel and ensuring compliance within a pharmaceutical cGMP facility.
• 10+ years of practical and progressive experience in a Quality related role in the pharmaceutical industry, with exposure to quality systems, analytical laboratory, microbiology laboratory and manufacturing of sterile products for commercial and clinical use.
• Additional training in aseptic/sterile manufacturing, like PDA, is a definite asset.
• Thorough knowledge of GMP, GLP, FDA, HPFBI regulations and guidance’s, combined with the ability to adopt best practices by responding quickly to a changing regulatory environment.
• Excellent organizational skills and multi-tasking ability.
• Excellent leadership, communication (written and verbal) and influencing skills.
• Demonstrated ability to work in a team environment and build high-performing teams.
• Proficient in the use of Microsoft software and Trackwise.

We offer a competitive salary plus potential bonus, benefits as well as an excellent opportunity to build your career with a well-established company with a corporate culture based on excellence.

While we appreciate all applications received, only those selected for an interview will be contacted

Job Types: Full-time, Permanent

Pay: $90,000.00-$95,000.00 per year

• Casual dress
• Dental care
• Disability insurance
• Employee assistance program
• Extended health care
• Flexible schedule
• Life insurance
• On-site parking
• RRSP match
• Tuition reimbursement
• Vision care
• Wellness program

Flexible Language Requirement:
• French not required

• 8 hour shift

Application question(s):
• Do you live in the Toronto Area? GTA

• Bachelor's Degree (preferred)

• • Quality Auditor Certification and audit: 7 years (preferred)
• quality assurance: 10 years (preferred)
• Canadian GMPs, FDA GMPs: 10 years (preferred)
• supervision/management position: 5 years (required)

Work Location: In person


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