Compliance Specialist
3 months ago
The compliance specialist performs the Annual Product Quality Review (APQR) as per client requirements and all applicable regulations.
He supports the planning, execution and follow up of regulatory and client inspections at the site, and supports the compliance audit team for the planning and follow-up of internal and external audits.
In addition, the specialist maintains the risk management program for the site. Finally, he does the Quality Assurance approval of many specific documents.
**Major responsibilities**:
- Obtains and analyses all data, including release and stability, related to each product over the specified covered period, as per the APQR schedule and client requirements; Assesses product related investigations, reports related changes, and performs all other required verifications as per client requirements and regulations; Suggests recommendations or corrective actions, when required; Prepares and maintains the APQR schedule;
- Supports the preparation of client and regulatory inspections (set up of rooms, review of hot topics, documentation review, action follow-up, etc.); Plays an important role during the audit, in the front room, back room, strategy room or else; Supports the action plan elaboration, reviews provided evidences and ensures CAPA closure as per specified timelines; Can support the compliance auditors as co-auditors during internal/external audits;
- Reviews and performs the quality assurance approval of specific documents (ex.: Stability protocols or reports, MPTP, Control Strategy, QRM, etc.);
- Maintains the risk management program and data integrity plan. Trains, teaches and helps to develop site employees to improve the understanding of risk management; Supports the execution, reviews and approves risk assessments and data integrity assessments; Ensures the execution and completion of actions from the annual data integrity plan;
- Supports the other compliance team activities (annual deviation review, supplier quality program, walkthroughs, etc.); Helps to develop tools to help monitor or improve the site compliance;
- Adheres to all applicable company procedures and policies (Finance, Health & Safety, HR, Information Technology, etc.) and any other regulatory requirements related to the Pharmaceutical Industry (GMP, etc.).
**Your profile**:
- Bachelor in science;
3 to 5 years in the pharmaceutical industry with quality experience;
Demonstrated experience with regulatory agencies including Health Canada, FDA, EMA and other Health Authority agencies. Strong understanding cGMP regulations in manufacturing, testing and packaging of drugs;
- Strong technical skills and ability to solve problems;
- Flexibility and ability to manage multiple priorities;
- Attention to detail; good teamwork skills.
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