OverviewTherapure Biopharma Quality Assurance Specialist – Internal Audits Full Time in Mississauga, ON
Branch Mississauga ON CA
Quality Assurance Specialist – Internal Audits
Maintenance of audit data and files for internal audits performed, manage audit CAPA data base, trend and prepare Quality Metrix review slides….
Therapure Biopharma Inc. is an integrated biopharmaceutical company that provides contract manufacturing services for the client, development, manufacture, purification, and packaging of therapeutic proteins. The position is accountable to address QA activities as assigned by the Manager relating to clinical and commercial manufacturing and related issues which directly or indirectly impact product quality.
Education & Qualifications:
University degree or equivalent in Science and 3-5 years of previous QA experience. Training in microbiology and/or sterile manufacturing experience is an asset.
Track record of compliance achievements
Detailed knowledge of GMP guidelines, Health Canada, FDA, EMEA.
Duties & Responsibilities:MAJOR RESPONSIBILITIES:
- Perform internal audits of all areas identified in the internal audit schedule, to assess compliance with site policies/procedures, regulations and Global Policies and Procedures.
- Document audit observations in a detailed written report and provide compliance assessment for the area/system/process audited. Perform a risk classification of all observations (critical, minor or major)
- Maintenance of audit data and files for internal audits performed, manage audit CAPA data base, trend and prepare Quality Metrix review slides
- Host Customer and Regulatory audits, prepare responses to Customer and Regulatory audits for review and approval by Director, Quality Operations
- Ensure that all work is performed in full compliance with Good Manufacturing Practices, Good Laboratory Practices, Standard Operating Procedures, all regulatory requirements, and established safety standards.
- Work independently or in a team, either within QA or with various departments, to ensure that all work is completed in a timely fashion to meet the quality, compliance and business needs.
- Work closely with Operations department to assist them in implementing and maintaining effective, risk based GMP processes, procedures and documentation.
- Performs additional duties as required.
Skills & Competencies:
Demonstrated ability to apply the following behavioural competencies on the job:
Goal Orientation: Energetically focusing efforts on meeting a goal, mission or objective
Communication: Clear and succinct verbal and written communication skills
Flexibility: Agility in adapting to change and ability to work independently. Ability to work different shifts on a permanent or rotational basis and occasional travel may be required.
Interpersonal Skills: Effectively communicating, building rapport and relating well to all kinds of people
Decision Making: Utilizing effective processes to make quality-based decisions
To apply for this position, please send your CV and cover letter to [email protected] .
Employment Type: Full Time
Location: Mississauga, ON, CA
Posted on: 2015-01-24