Website Apotex Inc
The Specialist, Systems Audit Support & IT Technical Compliance is responsible for providing IT compliance support for GMP systems during regulatory, internal corporate and customer inspections at Apotex Inc. In addition, this role will collaborate and support Apotex and the affiliate sites to ensure successful, compliant system implementations.
- In accordance with corporate established standards, perform IT Compliance audits of Apotex and affiliate sites, prepare reports and meet with management to review audit findings and, as necessary, assist in the investigation of audit findings to determine root cause and corrective/preventative actions.
- All other relevant duties as assigned.
- Develop and maintain effective relationships with key GIS SMEs at Apotex and affiliate sites, QA and other internal departments in order to ensure timely audits, communication, and resolutions to discovered deficiencies and/or concerns.
- Provide IT SME support and logistics support during inspections of Apotex sites by regulatory agencies and customers. Follow up and compile information to support response and commitments made in the response to inspection reports.
- Provide information/insight on regulatory requirements and stay abreast of changes in regulatory environment/trends.
- Works in a safe manner collaborating as a team member to achieve all outcomes.
- Provide technical and regulatory guidance to internal IT infrastructure and application implementers to ensure regulatory compliance of computerized systems. Provide input on the development of computer validation testing to demonstrate adherence to established regulatory and internal requirements.
- Participate in the development, implementation and maintenance of Enterprise Architecture standards for common GMP functions.
- Routinely examine published warning letters or observations given to other companies for IT compliance and challenge Apotex and affiliate sites against them.
- Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
- Examine IT practices against SOPs to determine if SOP are existent, adequate or requires update.
- 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.
- University or College degree in an Engineering or Science or Computer Science related program.
- Understanding of computerized systems as related to manufacturing, laboratory testing and clinical studies.
- Excellent verbal/writing skills in relation to providing written responses and actions towards an observation.
- Minimum 5 years experience in usage or implementation or validation of computerized systems in a regulated industry (eg: GMP)
- Knowledge of computerized systems architecture, data structure, security structure, network topology and software interactions.
- Familiarity with regulatory requirements of electronic records for US, Canadian, European and other countries regulatory agencies, including Electronic Records and
- Electronic Signature regulations like 21CFR Part11 and Annex11.
- Working knowledge of global guidance for data integrity.
- Minimum 2 years experience in implementing systems with emphasis on data integrity.
- Knowledge in validation or testing requirements to be able to develop criteria for challenging systems against requirements.
Company: Apotex Inc.
Job Category: Private
Vacancy Type: Full Time
Job Location: Peterborough, Ontario, CA
Application Deadline: N/A
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