Associate, Quality Assurance and Regulatory Affairs
The Associate, QA and RA position is responsible to enforce the quality system to ensure compliance with cGMP, GLP and other applicable regulations and industry standards at Diteba. This position involves decision-making and team coordination tasks.
Position Responsibilities:
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To enforce Diteba's quality system and encourage continuous improvement at Diteba to ensure compliance with GMP, GLP and other applicable regulations and industry standards within the organization.
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Conduct self-inspections within Diteba and vendor qualification evaluation. Identify quality deficiencies and advise on procedures, processes, and compliance issues. Follow up remaining quality and regulatory issues to ensure CAPA completion.
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Coordinate and hos regulatory agency inspections and client audits. Follow up according to audit reports to ensure CAPA's are completed in a timely manner.
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Review and prepare protocols, reports, SOP's, change controls, OOS/UR/OOT investigations and deviation investigation reports with minimum supervision. Consult regarding changes to existing production processes and the impact to product quality and stability.
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Review raw data generated by the analytical development laboratory, analytical reports and Certificated of Analyses. Ensure SOP’s, test methods, protocols and applicable SOP’s have been adhered to during the testing. Verify the integrity and traceability of all data generated and reported.
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Notify direct managers regarding omissions, incomplete testing results or other irregularities.
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Review instrument qualification data package.
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Attend teleconference meetings with the clients. Coordinate with external and internal clients to ensure timely completion of tasks.
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Documentation control and archiving activities. Manage training curriculum, coordinate training and maintain training records.
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Department administration coordination.
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Other tasks as assigned
Qualifications:
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Minimum B.Sc. degree in Chemistry, Biochemistry and other relevant life science fields. At least one year experience in the pharmaceutical industry, preferably in a Quality Assurance or Regulatory Affairs function.
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Fully comprehend Standard Operating Procedures (SOP) and current Good Manufacturing Practices (GMP/cGMP) and Good Laboratory Practices (GLP). Understand pharmaceutical manufacturing processes and concepts, analytical methodology, instrumentation qualification and pharmacopeias (USP, BP, EP, JP) as they pertain to analytical and bioanalytical investigations.
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Proficiency in computers such as Microsoft Word and Excel.
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Excellent interpersonal skills and written and oral communication skills are required.
If you are interested in submitting a resume to Diteba for this position, please send it to:
Human Resources
Diteba Research Laboratories Inc.
1620 Tech Avenue, Unit 3
Mississauga, ON, L4W 5P4
Canada
Email: info@diteba.com