Senior Officer, QA (BEC)-ARPL-BCA AR
Senior Officer, QA (BEC)-ARPL-BCA AR
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Job Description
About Apotex Inc.
Apotex is a Canadian-based global health company. We improve everyday access to affordable innovative medicines and health products for millions of people worldwide with a broad portfolio of generic biosimilar innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto with regional offices globally including in the United States Mexico and India we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions.
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Job Summary
Responsible for monitoring auditing and assuring the quality of operational aspects of the Facility according to established Standard Operating Procedures (SOP) Good Clinical Practices (GCP) Good Laboratory Practices (GLP) best practices and regulatory requirements with support of auditors & other senior members.
Job Responsibilities
- Ensures that assigned work is performed in accordance with GCP GLP SOPs regulatory requirements best practices and established safety standards as applicable.
- Performs audits (both project and non-project related) to assure the compliance to GCP/ GLP SOPs regulatory requirements of the following departments wherever applicable; Bio analytical Operations Clinical Operations Department Pharmacokinetic Unit Quality Assurance Unit and Other general divisional operations.
- Conducts in process surveillance (both project and non-project related) to assure ongoing compliance of the Bio analytical Operations/Clinical Operations/others Department as applicable.
- Prepares QA audit reports for all the above audits/surveillances performed.
- Conducts appropriate follow-up and take to completion any unresolved issues as a result of audit findings.
- Performs audit / review of software validation packages and IQ/OQ documents for systems used within the facility.
- Assists in the formal training of new and existing QA staff members to both QA and facility audit and procedures.
- Revise implements and maintains records of standards Operating procedures and additional relevant documents for the facility.
- Assists in Internal Audits whenever required.
- Reports to QA Management with respect to the operational status and disposition of all matters relating to the operations in the QA unit.
- Performs all work in accordance with all established regulatory and compliance and safety requirements.
- Works in a safe manner collaborating as a team member to achieve all outcomes.
- Demonstrate Behaviours that exhibit our organizational Values: Collaboration Courage Perseverance and Passion.
- Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program Global Quality policies and procedures Safety and Environment policies and HR policies.
- All other relevant duties as assigned.
Job Requirements
- Education
- Minimum Bachelor Degree holder in Science or Pharmacy.
- Knowledge Skills and Abilities
- Knowledgle on current Guidelines like ICH Guidlines GCP and GLP for BA/BE studies
- Technical skills on LIMS EP and Analyst software.
- Ability to perform audits in accordance to GDP GLP and GCP and other requlatory requirements.
- Experience
- Minimum 2-4 years Experience in Regulated Industry.
At Apotex we are committed to fostering a welcoming and accessible work environment where all everyone feels valued respected and supported to succeed.
We offer accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing please advise us if you require an accommodation.
Required Experience:
Senior IC
Employment Type
Full Time
