QA Release Specialist

- What you will be doing
PRIMARY DUTIES AND RESPONSIBILITIES:_- Product Release Management: Receipt, inspection and release of client specific products to market. 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, and other product release documents. Perform quality and regulatory reviews and oversight on imported products as assigned making quality decisions and addressing or resolving problems based on analysis and consultation with clients. Communication of batch status and issues effectively to all levels of the organization as well as supply chain.- Support Product Launch activities: Coordinate with clients and/or foreign sites or other internal departments with launch activities, the compilation of complete GMP Quality documents to support the importation of client products. Provide Quality Assurance guidance and support to potential new clients or new products as assigned.- Management of Customer complaints: receipt and triage of customer complaints, analyzes customer complaints and identifies trends and tendencies with respect to lot, product, and type of complaint and determines the cause; drafts complaint reports; recommends changes based on investigations and trend analyses- Maintenance of Master documents: Coordinate with clients and/or foreign sites for the receipt, review and updates to master documents to ensure compliance to GMPs and in relation to product release activities.- Maintenance of GMP Documentation: 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. Sustain 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.- Management and control of changes: supports the initiation of change requests for equipment, primary and secondary components, processes, systems and documentation; 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.- Deviation/Non
- Conformance Investigations: Investigate and document any discrepancies recorded during product handling and ensure product disposition decisions are made in conjunction with client and GMP regulations.- Involved in activities geared towards process and or document improvements: Support the QA department in ensuring Innomar 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 quality failures and non-compliance investigations; perform follow-up on corrective and preventive actions pursuant to an incidents; assist with process optimization; review of standard operating procedures; assist with internal and external audits.- Inspections: Provide support during audits/inspections by internal, client, third party or regulatory bodies.- Recall Management: provide support to the Senior Manager, QA for Product Recalls, including customer notification, coordination of customer returns and maintaining documentation.- AQPIC Activities: Assist the QPIC in the maintenance of standard operating procedures (SOPs) in compliance with Health Canada regulations. Assist the QPIC in ensuring that Innomar operates and is in compliance with the Narcotic Control Regulations as set out by Health Canada. Assist the QPIC to ensure that all transactions occurring at the respective distribution centre are in compliance with Innomar SOP’s relevant to the Narcotic, Precursor, and GMPs, including but not limited to Shipping, Receiving, Returns, Pick & Pack, Inventory Control, Credits, Security/Maintenance, Government Reporting, Record Maintenance, Destruction and Government reporting. Assist the QPIC in providing the Senior Manager, QA with any reporting to Government, regarding narcotic discrepancies and other required reports. Act as the back up to the QPIC.- Support Quality Organization: Provide assistance to the QA Senior Manager Quality Assurance as required. Performs other projects as assignedMay be required to be on standby/ on call as part of this role.
What your background should look like
EXPERIENCE AND EDUCATIONAL REQUIREMENTS:_Bachelor of Science degree requiredMinimum of 3-5 years’ experience in GMP Quality Assurance/Quality Control/ComplianceDirect pharmaceutical Quality Assurance/Quality Control/Compliance experienceRegulatory Affairs or Quality Assurance Certification as asset
- MINIMUM SKILLS, KNOWLEDGE AND ABILITY REQUIREMENTS:_Must have full and complete knowledge of the Good Manufacturing Practices and applicable Health Canada regulations and guidelines (i.e., Dr