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Quality Assurance Manager
2 months ago
Job Summary:
The Quality Assurance Manager will be responsible for providing oversight and support to the quality systems at Paladin Pharma. This includes involvement in technical transfer and validation initiatives, deviations, CAPAs, change controls, complaints, audits, stability, training, product release, and APQRs. The person will act as lead Quality support on project(s) assigned by managers to maintain and provide continuous improvement of Paladin systems and products.
Key Responsibilities:
- Provide oversight and support to the quality systems at Paladin Pharma.
- Involve in technical transfer and validation initiatives, deviations, CAPAs, change controls, complaints, audits, stability, training, product release, and APQRs.
- Act as lead Quality support on project(s) assigned by managers to maintain and provide continuous improvement of Paladin systems and products.
- Supervise the QA batch release functions for cGMP commercial and distribution activities from the contract manufacturing, filling, testing, and packaging facilities.
- Prepare and/or review controlled documents, such as SOPs, work instructions, and batch records.
- Assist with all aspects of quality systems, such as Change Control, Deviations, Investigations, complaints, and CAPA systems to assure compliance and timely and accurate completion of reported events.
- Contribute to the development, management, and improvement of quality systems and procedures to ensure compliance with all applicable laws, regulations, and company quality standards in support of cGxP/ISO 13485 activities.
Requirements:
- Bachelor's degree in science.
- ~8+ years of experience in a quality function in the pharmaceutical/biopharmaceutical industry.
- ~3+ years' experience in people management.
- ~Strong technical writing skills and a good command of general grammar and usage.
- ~Bilingual (French and English) with excellent oral and written communication skills.
About Us:
Paladin Pharma is a leading specialty pharmaceutical company focused on acquiring or in-licensing new pharmaceutical products for the Canadian market. Its dedicated employees have made Paladin one of Canada's pioneering specialty pharmaceutical companies. Paladin is an operating company of Endo USA, Inc, a highly specialized pharmaceutical company that brings quality branded and generic products to patients through excellence in development, manufacturing, and marketing.