QA Coordinator - Equipment validation and Calibration

at  Viva Pharmaceutical Inc

OVERVIEW

Successful applicants will have experience working in a regulated production environment, preferably in the area of pharmaceuticals or nutraceuticals. The position requires a high level of organization and attention to detail, as well as critical thinking, interpersonal communication, and a strong aptitude with computers.

QUALIFICATIONS

• BSc Degree in mechanical or other engineering with 2+ years related experience and/or training on related scientific field such as pharma and nutritional industry.
• Excellent communication and writing skills and a familiarity with Microsoft Office and Adobe PDF electronic software.
• Well-organized with experience in good documentation Practices.
• In-depth knowledge of GMP’s, with 3 years’ experience in a Validation / Engineering role or QA/QC experience in the pharmaceutical/nutraceutical or biotechnology industries.
• Good working knowledge of Canadian and US GMP regulatory requirements would be considered an asset.
  Job Types: Full-time, Permanent
  Pay: $48,000.00-$55,000.00 per year

Additional pay:

• Bonus pay
• Overtime pay

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Work Location: In perso

• Preparation of Installation Qualification (IQ), Operation Qualification (OQ) and Performance Qualification (PQ) protocols for all new equipment/utility/computer system and execution of IQ/OQ/PQ qualification/validation tests, complete qualification/validation reports and summary reports ready for approval.
• Identify, respond, and monitor potential project risk and determine possible contingency plans for risk mitigation.
• Coordinate the implementation of calibration program and preventive maintenance activities on monthly with engineering, technician, production, and contractors.
• Write and update SOP’s, perform risk assessments, training and coordinate implementations.
• Check records and data for completeness and accuracy as well as to confirm compliance with internal procedures and regulations.
• Carry out QA functions to assure conformance with GMP for equipment requirements as needed for pharmaceuticals/nutraceuticals Compliance.
• Assist in the maintenance of quality system, records, and corporate documentations. Coordinate with other Departments on QA related issues.
• Implement quality policies related to calibration and Preventive maintenance by facilitating and enforcing supportive activities from staff at all levels.
• Review SOPs, equipment, facility, utility, and process validation/qualification protocols and reports.
• Performs other duties as requested by QA manager and senior management.