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:
MICROBIOLOGY MANAGER
The Microbiology Manager, reporting to the Director of Quality, will be responsible for day-to day management of the Microbiology Laboratory and all microbiology testing at Dalton to ensure compliance with cGMP regulations, following internal, client and compendial methodologies. The incumbent will provide guidance for method development and validation, propose and implement improvements, and perform investigations for product and environmental monitoring excursions, while coordinating and prioritizing the laboratory workload to meet client requirements and turn-around time.
The successful candidate should meet the following qualifications and requirements.
Experience Required- Strong knowledge of regulatory requirements (Health Canada, FDA and EU) for microbiology testing related to the manufacturing of sterile and non-sterile pharmaceutical products.
- Knowledge of the recently implemented Annex 1 and ability to perform a comprehensive gap analysis and implement actions to meet requirements.
- Experience writing microbiological Standard Operating Procedures, method/equipment qualification protocols and method transfers.
- Extensive experience performing testing for the enumeration and identification of microorganisms from raw materials, products, environment, and utilities.
- Extensive experience in conducting and/or reviewing microbial and/or endotoxin OOS investigations and the implementation of corrective actions and preventive actions (CAPAs) via change controls.
- Responsibility for a Microbiology Laboratory to ensure timely completion of raw materials, in process testing and Drug Substance/Product release.
- Performing routine record review and data analysis to identify trends. Update management on trends and implement corrective action plans when necessary.
- Representing the company as an SME during GMP regulatory inspections and client audits to address microbiology issues and develop solutions.
- Experience in coaching, mentoring, and training not only microbiologists but cross-functional team members in microbial principles and behavior in environmentally controlled clean rooms.
- Establishing a strong Microbiology presence in the organization by working closely with and assisting other teams to solve microbiology related issues.
- Managing a team of professional(s) including performance management, succession planning (coach and develop employees) and distribution of workload.
- A minimum Bachelor’s university degree in Microbiology. Preference will be given to candidates with an advanced degree.
- 5+ years of experience as a Microbiology Manager, responsible for leading a team of microbiologists within a biotechnology/pharmaceutical aseptic manufacturing environment facility.
- 10+ years of practical and progressive experience in a microbiology related role in the pharmaceutical industry for commercial and clinical drug products.
- Demonstrated experience in microbial and endotoxin testing of in-process & finished product, aseptic process simulations, environmental monitoring and testing of utilities (water, steam, etc).
- Thorough knowledge of GMP, FDA, Health Canada and EU 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.
Analytical Chemist II/Senior Analytical Chemist
We are seeking a skilled Analytical Chemist II/Senior Analytical Chemist with a B.Sc. or a M.Sc. in chemistry and 3+ years of experience using HPLC and GC in the pharmaceutical industry, you are logical and have excellent oral and written communication skills.
You will be required to conduct the following:- Working in a very fast paced environment by performing analytical testing of assigned materials or products within required deadlines.
- Use of analytical instruments to generate analytical data, instrumentation to include HPLC, FTIR, UV, Karl Fischer, pH meter, osmometer, and other analytical equipment as required.
- Participate in the development and validation of methods as required.
- Engage in Method Life cycle management for continuous improvement
- Working closely with others in the group to maintain laboratory equipment and procedures.
- Following all safety policies and maintaining a clean and orderly work area.
- Maintenance and upkeep of instrumentation.
- Maintenance of documentation, including lab notebooks, equipment logbooks and analytical data.
- Interpretation of analytical data.
- Provide analytical documentation support to Customer Service, Business Development and Product Development departments as required.
- Summarize and present data in a professional/technical manner.
- Write, implement and maintain SOP’s for the analytical laboratory.
- Perform all GLP/GMP activities in compliance with GLP/GMP guidelines & Dalton SOP’s.
- Actively participate in Laboratory investigations and support effective CAPA
- Any other duties which might arise during the course of a project
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