Job Description

Pancap Pharma Inc. is a leader in specialty contract manufacturing of pharmaceutical dosage forms. The company began its contract manufacturing operations in January of 1994 and since then has translated experience into quality production for a wide range of clients. From concept to full package delivery, we have the experience and commitment to meet the needs of even the most unique clients. We offer a wide range of manufacturing and support capabilities including capsule fabrication, compounding of non-sterile liquids, packaging, labelling, regulatory affairs, testing and quality assurance. The products we manufacture are then shipped around the world. Quality is the cornerstone upon which Pancap has built its foundation. Our Quality Assurance System was developed in order to ensure the production of safe and effective products in compliance with the current Good Manufacturing Practice (cGMP) regulations, industry standards and our client\'s specifications/marketing requirements. We are growing our operations with a brand-new state of the art facility in Windsor, Ontario and we are looking for a Quality Assurance Associate. ROLE AND KEY REPSONSIBILITIES

• Manage the GMP Documentation, Change Controls, OVR, OOS, OAL, MVR
• CAPA Management \xe2\x80\x93 manages/tracks site CAPA program and ensures all departments are meeting obligations for CAPA based on deviation, complaints, audits, change controls
• SOP Management \xe2\x80\x93 oversees site GMP related SOP\xe2\x80\x99s and ensures that they are meeting current corporate and regulatory requirements
• Complaints \xe2\x80\x93 Provides QA support for complaint investigation
• Manage the preparation/review and day to day activities of the APR (Annual Product Review) Activities
• Monitors and Reviews Facility Purified Water, Air Flows and Environmental Reports
• Audits & Trends PM (Preventative Maintenance) Program
• Maintenance of Quality Agreements with Suppliers, Customers, Contractors
• Participate in Client Audits and Regulatory Inspections
• Responsible for monitoring and timely requisition of laboratory supplies
• Perform other duties as assigned
• Manage calibration and maintenance of data loggers\xe2\x80\x99 system

QUALIFICATIONS AND EXPERIENCE

• University Degree or College Diploma in a science related field
• 2-5 years Quality Assurance Experience in a Pharmaceutical environment
• Technical writing in a Pharmaceutical Industry is an asset
• Knowledge of laboratory testing equipment such as UV, IR, Titrators would be an asset
• Advanced word processing skills in Microsoft Word, Excel, PowerPoint
• Excellent oral and written English communication skills
• Deadline oriented with a flexibility to work in a multitasking environment
• Works well in a fast-paced environment both individually and as part of a team.

Job Types: Full-time, Permanent Benefits:

• Extended health care

Schedule:

• 8 hour shift
• Monday to Friday

Supplemental pay types:

• Overtime pay

Experience:

• quality assurance: 1 year (preferred)

Work Location: One location