Position duties and Responsibilities:

• Knowledge in qualification and validation activities for computer systems and IT infrastructure.

• Experience working with Laboratory Information Management Systems (LIMS), Lab Execution Systems (LES) and Manufacturing Execution Systems (MES).

• Experience in installation and validation of chromatographic instruments and related software systems, and general pharmaceutical quality control and R&D laboratory instrumentation/equipment such as Dissolution systems, DSCs, and Balances.

• Know how in software implementation, computer system validation, equipment qualification etc. in regulated cGMP/GxP environments.

• Experience working in GxP regulated Environments.

• Good understanding of GxP and regulatory Data Integrity requirements (ALCOA+), as well as understanding of Pharmaceutical Data risk assessment (as related to Quality Assurance, and Quality Control and Product release).

• Good understanding of GAMP, FDA, ICH and other relevant regulatory requirements in the MedTech and Pharma industries. Specifically, knowledge of 21 CFR parts 11, 210, 211, 600, 610, and 1271 along with associated best practices (e.g. ISPE GAMP) for CSV qualifications.

• Understanding of Change Control and Quality Documentation in the MedTech and Pharma Industries.

• Understanding of CSV and IT infrastructure qualification and validation activities and deliverables (e.g. VPPs, RAs, IQs, OQs, PQs, VSs, RTM, etc.)

• Able to write Validation Project Plans (VPP), IQ, OQ, PQ protocols, and Validation Summary Reports (VSRs).

• Experience in System Development Life Cycle (SDLC)

• Working knowledge of corporate Quality Management Systems, current Good Manufacturing Practices (cGMP), and Good Clinical Practice (GCP)

Job Qualifications:

• Graduate degree in Computer Science, Engineering, Information Systems, or related technical field or 10+ years direct, relevant CSV experience in MedTech or Pharmaceutical Quality Control and/or R&D.

• Strong computer, scientific, and organizational skills

• Strong root-cause analysis skills

• Deadline and detail-oriented • Knowledge of 21 CFR Part 11 requirements and data integrity • Knowledge of risk-based Change Management and Quality Management systems.

• Strong communication skills.

• Must be able to travel within north America and abroad.

• Knowledge of 21 CFR Part 11 requirements and data integrity

• Knowledge of risk-based Change Management and Quality Management systems.

How to apply:

• Please submit your resume to careers@complianceassociates.ca

Only those selected to move forward in the recruitment process will be contacted. Please contact

(905) 738.3773 or email: careers@complianceassociates.ca for further information. Mailing address: 5160 Explorer Drive Unit 31 Mississauga Ontario L4W 4T7.