Quality Control, Quality Assurance & Microbiology
Quality Control is responsible for sample testing to fulfil the quality requirements of Health Canada, FDA and International Regulatory bodies. Quality Assurance ensures that production materials meet quality specifications and are compliant with regulatory guidelines through our planned and systematic quality systems. The primary purpose and mission of the department is to analyze the microbiological nature and make-up of substances, using a variety of modern microbiological techniques, methods and instrumentation for its customers in a highly efficient, cost effective and timely manner.
The Microbiology department is involved in work as diverse as microbiological analysis, quality control, environmental monitoring and trending, microbiological support activities for sterile manufacture, microbiological method development and validation as well as microbiological support for manufacturing process development as required.
We are always looking for new people to contribute to the company's growth. We offer a competitive salary and benefits and an excellent opportunity to build your career with a growing company. Thank you for your interest in working at Dalton Pharma. Please note that successful applicants will be notified by email within 2 weeks if they are selected for an interview. We do keep resumes on file. If we have an opening that better fits your career goals and experience, we will contact you.
Please forward your resume to:
Human Resources Department
Dalton Pharma Services Inc.
Email:
POSITIONS CURRENTLY AVAILABLE:
Quality Compliance Manager
The Quality Compliance Manager, reporting to the Director of Quality, will be responsible for managing all quality activities at Dalton to ensure compliance with cGMP regulations and internal processes, and to provide guidance and support to facilities, manufacturing, and the analytical/microbiology laboratories.
The successful candidate should meet the following qualifications and requirements.
Experience Required
- 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 leading the preparation of and hosting customer 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.
- Negotiating and approving quality agreements with clients to ensure quality standards and expectations are mutually agreed to and in line with the defined specification to assure quality and safety of the product. Ensuring quality agreements are maintained and up to date.
- Managing of the Vendor Qualification program, including: establishing and maintaining the vendor audit schedule, performing on-site and/or paper vendor audits, and evaluating vendor performance to determine approval and/or certification status.
- Providing oversight of Site Master Files, Annual Product Quality Reviews, Stability programs and Quality Metrics.
- Knowledge of the DEL application and amendment process, including foreign sites.
- Developing and revising Standard Operating Procedures (SOPs) in response to observations and to reflect new or transpiring regulatory changes in cGMP/GXP guidelines.
- 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, or equivalent, in a Science discipline. Preference will be given to candidates with courses in microbiology.
- 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 for commercial and clinical drugs.
- Experience working in an aseptic manufacturing environment is an 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.
Microbiology Manager
As the head of Microbiology team, the Microbiology Manager will be responsible for the overall operation of the department dynamic that plans and executes microbiology related tasks and activities according to project scope of work, deadlines and budget.
The successful candidate should meet the following qualifications and requirements.
Qualifications and Requirements:
- Working closely with internal teams and suppliers, the Manager, Microbiology will provide leadership in establishing and maintaining the corporate quality systems and standards.
- Strong understanding and sound interpretation of the Canadian GMPs, FDA GMPs and other related guidelines, Medical Device Regulations.
- Proven track record of leading a high performing Microbiology team, including scheduling team workloads, setting priorities and meeting deadlines.
- Strong Quality and risk-based approach decision making.
- M.Sc. in a Microbiology degree.
- At least 7 years working experience in Microbiology lab in a GMP environment, with minimum 5 years in supervision/management position.
- Strong verbal and written communication skills
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