QA Compliance Specialist

4 weeks ago

Milton, Canada AmerisourceBergen Full time

- What you will be doing
PRIMARY DUTIES AND RESPONSIBILITIES:_- Management of Stability Program: obtain and review stability studies, confirms product expiry terms based on data analyses and confirm stability of product on the market- Management of the Annual Product Quality Report Program: support the APQR program by obtaining and reviewing documents related to the products; confirm product specifications are current within the master document files, confirms all changes have been documented, compiles trend-analysis data and writes a trend-analysis report.- Management and control of changes: supports the evaluation of change requests for equipment, primary and secondary components, processes, systems and various types of documents; monitors follow-up with parties involved; ensures that deliverables are compliant pursuant to the change; closes changes upon implementation. Management of trend reporting for changes.- Validation Management: ability to lead and manage Commissioning/Validation/Re-qualification projects for 3 sites and to ensure quality and compliance with regulatory requirements-
- Master Document Files: Coordinate with clients and/or foreign sites in the compilation of complete GMP Quality documents to support the importation of assigned products. Perform timely review and assessment of documents received from clients/foreign sites, including but not limited to, manufacturing and packaging records, Certificates of Analysis, Certificates of Manufacture, stability reports and other product release documents. Maintain and review in-house and client-based quality documents such as APQR, stability reports, equipment and facility qualification/validation protocols and reports, product label, temperature study etc. to support release to the market.- Management of Quality Agreements: Development and Maintenance of client Quality Agreements and internal procedures to support the agreements.- Training Management: Implement GMP Training Program and maintain training records for new and current associates, including GMP training, Innomar Strategies Inc. SOPs, Client SOPs, and Corporate Security and Regulatory Affairs (CSRA) Policies as applicable.- Preventive Maintenance and Pest Control Management: provide quality compliance oversight and support to ensure a compliant Preventive maintenance, EM and pest control program- Deviation Management: provide quality compliance oversight and support associated with nonconformance and incident reporting ensure product disposition decisions in conjunction with client and Health Canada requirements.- Customer complaints Management: provide compliance support to tracking customer complaints; works with client to identify trends and tendencies with respect to lot, product, type of complaint and determines the cause, trend analyses and drafts complaint letter to customer as appropriate. Implement and manage an effective system for maintaining copies of documents received from clients/foreign sites as well as those submitted to Health Canada, allowing ease of location and retrieval of records.- Controlled Drug/Narcotics Handling: support the site’s controlled substance handling, inventory, destruction and compliance activities.- Involved in activities geared towards procedural improvements: Support the QA department in ensuring Innomar Strategies Inc. GMP facilities operate and are in compliance with Good Manufacturing Practices and applicable Health Canada regulations at all times which may include review and approval of product-quality failure and non-compliance investigations; performs follow-up on corrective and preventive actions pursuant to an incident; performs trend analysis on systems and processes to ensure process optimization; reviews standard operating procedures; assists with internal and external audits. Assist in the development and implementation of Quality policies and procedures to ensure that regulatory compliance is maintained or enhanced.- Product Release Management: support QA department and act as backup to approval of manufacturing and packaging master files; review of batch records for manufacturing, packaging, testing, and deviations; ensures documents are in compliance; releases or rejects lots of raw materials, packaging components, imported bulk goods intended for production, and finished products intended for retail; issues appropriate certificates; assesses product returns. Assist in product launch activities as assigned. Provide regulatory and Quality Assurance guidance and support to potential new clients as assigned. Work with other functional areas to resolve issues related to information for regulatory submissions.- Inspections: Provide support during audits/inspections by internal, client, third party or regulatory bodies.- Support Quality Organization: Provide assistance to the QA Senior Manager Quality Assurance as required. Performs other projects as assigned.May be required to be on standby/ on call as part of this role.
What y

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