Validation Analyst 1

2 months ago

Mississauga, Canada PCI Pharma Services Full time

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI.

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

Summary of Objective:
Responsible for planning, executing and leading various validation project assignments. Including execution of line trials, development of validation strategy, qualification of equipment, processes, instrumentation and systems related to the packaging operation. Works closely with Tech Services, Production and Customer Service teams to ensure customer specifications are met and that these specifications comply with internal operating standards. Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.
1. Generation of line trial protocols.
2. Execution of line trials with the support of Tech Services or Maintenance as required.
3. Review and approval of executed line trials.
4. Works with the Technical Writer to ensure line trial learnings are captured in master production batch records.
5. Generation of IQ/OQ documents for new equipment.
6. Execution of IQ/OQ activities with the support of Tech Services or Maintenance as required.
7. Develop and recommend validation strategies for product portfolios.
8. Generation of PQ protocols.
9. Provides training and support to production in the execution of PQ protocols.
10. Generation of PQ summary reports.
11. Provide technical assistance during investigations of process /equipment / cleaning / validation issues
12. Generate and resolve validation deviations / protocol discrepancies.
13. Support, investigate and troubleshoot problems and determine possible solutions.
14. Identify, respond and monitor potential project risk and determine possible contingency plans for risk mitigation.
15. Serve as a dependable technical liaison between Quality and Production.
16. Undertakes the calibration and validation of equipment and systems.
17. Assists the technical services department with annual equipment evaluation based on trending of data from PM etc. to proactively address potential issues with equipment.
18. Work on multiple projects and shift priorities as needed, track and update validation / client management on assigned projects.
19. Investigates, develops and documents Deviation/Incident Reports related to validation runs with the guidance from the Sr. QA Manager.
20. Execution of mapping studies for warehouse and cold rooms as required.
21. Management of site Pest Control program.
22. Administration & distribution of monthly PM (preventive maintenance) requirements to Tech Services
23. Logging of PM activities in the PM database.
24. Management of the PM Database, including assigning asset #s to new equipment and creating PM schedules for new equipment.
25. Assists with new product assessments to determine if a product can be packaged on-site and if cleaning validation is required.
26. Execution of cleaning validation studies, including protocol generation and summary.
27. Consistently applies company SOP’s relative to production, quality and pharmaceutical standards
28. Responsible for monitoring and adhering to GMP as well as Health and Safety Policies and Procedures; raises concerns or issues to the Sr. QA Manager.
30. This position may require overtime and/or weekend work.
31. Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.
32. Attendance to work is an essential function of this position.
33. Performs other duties as assigned by Manager/Supervisor.
34. Other duties as required. Special Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be physically capable to perform the duties listed below with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions
- Stationary Position: From 1/2 to 3/4 of the day.
- Move, Traverse: From 1/4 to 1/2 of the day.
- Operate, activate, use, prepare, inspect, or place: From 1/4 to 1/2 of the day.
- Install, place, adjust, apply, measure, use, or signal: None.
- Ascend/Descend or Work Atop: From 1/4 to 1/2 of the day.
- Position self (to) or Move (about or to): From 1/4 to 1/2 of the day.
- Communicate or exchange information: From 1/2 to 3/4 of the day.
- Detect, distinguish, or determine: From 1/2 to 3/4 of the day. On an average day, the individual can expect to move and/or transport up to 50 pounds less than 1/4 of the day. This position may have the following special vision requirements. Close Vision Distance Vision Color Vision Peripheral Vision Depth Perception Ability to

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