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.
Please forward your resume to:
Human Resources Department
Dalton Pharma Services Inc.
POSITIONS CURRENTLY AVAILABLE:
Senior Analytical Chemist
As a Senior Analytical Chemist with a M.Sc. or Ph.D. in chemistry and 7+ years’ experience using HPLC and GC in the pharmaceutical industry, you are logical and have excellent oral and written communication skills. You have great accuracy and precision in all testing that you conduct and interpretation of analytical data and technical report writing are your forté.
You will be required to conduct the following:
- Testing using a wide variety of equipment including HPLCs with UV, DAD, ELSD and electrochemical detectors, GCs (including capillary column and headspace) with FID and TCD detectors, Karl-Fischer, UV-vis, FTIR, oxygen headspace, Osmometer, automatic titrators, oxygen analyzers, pH meters
- Carry out wet chemistry analysis.
- Participation in development and validation programs.
- Develop various methods for determination of different chemical entities and their properties, such as small molecules, peptides, proteins, DNAs and RNAs.
Analytical Chemist, Research and Development
We are seeking a skilled Analytical Chemist, Research and Development with a M.Sc. or Ph.D. in Chemistry with 3+ years of experience with Method development and validation in Analytical R&D.
In this position you will be responsible for development and validation of analytical test methods for the product development. Key duties include design, development and validation of new analytical methods, protocols and reports write-up, draft specifications and other documents for regulatory submissions. Testing of R&D batches, raw materials and packaging components in accordance with GMP/GLP regulations may be required as needed. Work should be completed with little supervision/guidance in a timely manner.
To qualify for this position, the candidate must possess the qualifications:
- Complete all training assignments, SOPs and maintain personal training records
- Develop and validate new analytical methods with minimum supervision
- Execute and document all research work in accordance with current GMP/GLP regulations
- Maintain a clean laboratory environment and ensure that safety regulations are followed
- Interpret and compile analytical data, propose next steps on discussion with the Manager
- Prepare protocols, development and validation reports
- Participate in activities leading to product approval (i.e. deficiency letter responses for chemistry issues, investigations, etc., with specific tasks outlined by the Manager)
- Provide technical support and coaching to other R&D Analytical Chemists
- Participate in and/or lead for out-of-specs Investigations
- Complete Corrective and Preventative Actions (CAPA’s)
- Initiate and follow through with actions required to close Change Controls
- Research and prepare specifications for product and packaging material
- Attend project meetings and prepare project updates
- Participate in Internal, Customer and Regulatory Audits
Knowledge, Skills and Abilities:
- Superior theoretical and practical knowledge of organic, inorganic, physical and analytical chemistry including in-depth knowledge of gas and liquid chromatography, spectroscopy and other analytical techniques employed in the pharmaceutical development
- Familiarity with modern computer assisted analytical instrumentation methods as well as with older techniques (i.e. titration)
- Good understanding of GMPs and GLPs as well as with pertinent FDA and ICH guidelines
- Ability to communicate and operate effectively in a team environment
- Knowledge of applicable software
- Good organizational and Multi-tasking skills. Detail-oriented.
- Excellent written and verbal communication skills.
- Problem solving skills with significant degree of judgment based on prior experience, scientific knowledge and literature search. Problems include routine and non-routine tasks, such as chemistry related issues (i.e. understanding the degradation pathway of the active), instrumentation related problems (understanding symptoms of HPLC problems and eliminating/repairing them) and first review of out-of-spec investigations.
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