This position is responsible for monitoring and performing various GMP QA related activities for Sun Pharma Canada business. The position is full time permanent position and will report to Senior Manager, QA. The primary responsibilities include product release and management of master documents from suppliers, SOP management through EDMS, Deviation, Change Controls, CAPA Management, and coordinating Annual Confirmatory Testing with Canadian Laboratory.
Principal Duties and Responsibilities:
- Request and maintain supplier master documents for products released in Canada.
- Perform incoming product inspection, download temperature data and review incoming product receiving documents.
- Initiate and review change controls for any changes at SPCI or at the manufacturing site.
- Manage 3rd party lab testing as governed by internal SOPs and applicable regulations.
- Perform collaborative review of incoming product for release to Canadian market for support to Supply Chain.
- Co-ordinate warehouse QA activities for incoming inspection and release based on determined priorities.
- Write new SOPs/Forms and modify existing SOPs/Forms to ensure process are current and relevant.
- Based on EDMS User role, act as EDMS Site Coordinator according to established SOP. Oversees site GMP related SOPs and ensures that they are meeting current corporate and regulatory requirements. Support GSOP management at site level.
- Interact with suppliers for receipt of release documents and supporting issues.
- Initiate Deviations and route it through QMS TrackWise system for investigation completion and closure.
- Initiate Change Controls (CCR) and revise GMP documentation as driven by internal SOPs.
- Review supplier batch documents (CoA, CoM, CCR, OOS/deviation where applicable and relevant batch Records) and support product release in Canada as per applicable Health
- Participate in site CAPA program, and ensures that all departments meet their obligations for completing CAPAs resulting out of deviations, complaints, audits and/or any other source.
- Manage QA portion of the Return Goods Process including review of documents and final disposition within SAP and at the warehouse for the returned goods.
- Perform Executed Batch Record (EBR) review as assigned.
- Based on QMS TrackWise User role, act as designee for SPCI PQC Complaint Coordinator role according to established SOP.
- Based on Learning Management System User role, act as SPCI Training Coordinator according to established SOP.
- Manage receipt of the product samples, placebo and reagents for annual confirmatory testing program.
- Manage communications with the testing laboratory and ensure timely testing of Sun Pharma samples.
- Perform documentation filing and other duties assigned by the manager.
Knowledge Skills & Abilities
- Strong communication skills (written and oral) including presentation skills
- Proven problem solving ability with evidence of good judgment and decision making skill
- Strong organizational ability and management of multiple priorities combined with proven ability to meet strict and established timelines
- Strong experience combined with Quality Assurance and 3PL Compliance background
- Excellent working knowledge of GMP and regulatory requirements for the pharmaceutical industry
- Strong proficiency with applicable computer software
- Successful candidate may be required to undergo a police clearance process as required by the Health Canada, the Royal Canadian Mounted Police and Justice Canada guideline in reference to the sale and distribution of narcotics
Background and Experience
- University level degree (B.Sc.) in a Science or equivalent in discipline acceptable to Health Canada standards
- Minimum 2-3 years of relevant experience within the pharmaceutical industry, 3PLI Quality Assurance, and handling of narcotic products
- Ability to prioritize workload, multi-task and maintain compliance
- Extensive inter-personal contact with other department professionals, plant staff, admin staff and international counterparts, e.g. Head Office, etc. as well as external partners: SGS Contract Testing Lab, Warehouse Services; Q-Pharm, Lear, Third Party Suppliers, Business Partners
- Fairly pleasant surroundings and work environment.
- Continuous sitting may be required, with mix of standing and walking
- Ability to lift up to 20lbs occasionally
- Ability to perform other tasks as assigned by the supervisor