Quality Assurance Manager
4 days 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. Finally, the manager will assure compliance with current domestic and international GMPs and regulatory agencies.
Key Responsibilities:
- Quality Systems Management: 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.
- Quality Assurance: 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.
- Batch Release: Supervise the QA batch release functions for cGMP commercial and distribution activities from the contract manufacturing, filling, testing, and packaging facilities, including non-MRA requirements and product return process.
- Document Control: Prepare and/or review controlled documents (e.g., SOPs, Work Instructions, and other quality-related documents).
Requirements:
- Education: Bachelor's degree in science.
- Experience: 8+ years of experience in a quality function in the pharmaceutical/biopharmaceutical industry.
- Leadership: 3+ years' experience in people management.
- Communication: Strong technical writing skills and a good command of general grammar and usage.
- Language: 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. As an operating company of Endo USA, Inc., we bring quality branded and generic products to patients through excellence in development, manufacturing, and marketing.
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