Manager, R&D QA Liquid Dose (Richmond Hill)

Manager, R&D QA Liquid Dose (Richmond Hill)

31 Aug
|
APOTEX
|
Richmond Hill

31 Aug

APOTEX

Richmond Hill

Apotex is a Canadian-based global health company. We improve everyday access to affordable, cutting-edge medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions.

The Manager, R&D; QA Liquid Dose is responsible for developing and maintaining a focused team, skilled and trained to support the compliance and business needs of R&D; manufacturing, packaging and laboratory operations in support of New Product Development at Richmond Hill. Overall responsibilities include the disposition decisions made on R&D; semi-finished and packaged materials, review and approval of experimental batch manufacturing documents, supervising and training staff, preparing and responding to audits, point of contact for local quality issues, ensuring investigation and deviations are handled in a compliant manner with pre-defined timelines, and working with the Associate Director, CMC QA to develop programs for ensuring the continuous improvement in the quality of operations in Product Development Manages the on-going QA activities which support the business and GMP compliance needs of manufacturing, packaging and laboratory operations in Product Development. Interacts with Richmond Hill R&D; manufacturing/packaging groups, laboratories and R&D; Project Management to determine scheduled activities and changes to the manufacturing schedule.





Oversees assignment of work to direct reports for the review and approval of R&D; manufacturing/packaging masters and executed manufacturing/packaging batch documents, as well as the review and approval of R&D; specifications, test results, release of experimental raw materials (API, excipients and packaging components) and non-commercial finished product batches (such as IMPs and submission batches). Reviews and approves Master Manufacturing/Packaging Masters and executed batch records for non-commercial materials (such as IMPs and submission batches). Review and approve documents required for regulatory submissions.

Review, coordinate and approve activities for deviation investigations and CAPA for experimental materials and manufacturing of non-commercial batches. These include the complaint investigations for IMPs. Supports change through review and approval of change control requests for master manufacturing/packaging documents, analytical methods, specification, SAP material code creations, SAP Master Data, Standard Operating Procedures (SOPs) and other controlled documents.

Ensure implementation of appropriate processes and continuous improvement initiatives in order to maintain effective quality standards in R&D.; Provides assistance and leadership in preparation activities leading up to, during, and following regulatory or customer inspections. Provides support and management of the R&D; self inspection program at Richmond Hill.





Serve as primary contact and consultant for quality issues pertaining to R&D; operations. In conjunction with the Associate Director, CMC QA, conducts appropriate resource planning analysis for headcount forecast. Participate and lead performance conversations with employees, check in on employee’s progress toward achieving Objectives, offer support and remove barriers; and, communicate and revisit performance expectations to reinforce and encourage high performance culture and a safe working environment for all employees.

Create a culture which values trust and provides the opportunity for Employee development and growth in pursuit of our purpose and demonstrating our core Values – Collaboration, Courage, Perseverance and Passion. Ensure adherence of direct reports with all compliance programs and company policies and procedures. Thorough understanding of GMP requirements and their application in a manufacturing and packaging environment within R&D; for pharmaceutical liquid dosage forms Strong understanding of regulatory requirements for IMPs and registration batches Experience with technical report writing / scientific documentation Minimum six (6) years of QA experience in the pharmaceutical industry, three (3) years of supervisory experience, preferably in a QA role We offer accommodation for applicants with disabilities as part of its recruitment process.

The hiring range for this position is $96,551 - $160,918 CAD per year. Apotex offers bonus programs based on your position in the organization, you can excel based on our pay-for-performance philosophy. With comprehensive benefits, a pension plan to help you save for retirement and learning and development opportunities, we provide a comprehensive package for your personal and professional development.

📌 Manager, R&D QA Liquid Dose (Richmond Hill)
🏢 APOTEX
📍 Richmond Hill

Reply to this offer

Impress this employer describing Your skills and abilities, fill out the form below and leave Your personal touch in the presentation letter.

Subscribe to this job alert:

Get the latest job offers by email for: manager, r&d qa liquid dose (richmond hill) / richmond hill

Subscribe to this job alert:

Get the latest job offers by email for: manager, r&d qa liquid dose (richmond hill) / richmond hill