Validation Analyst Ii - Mississauga, Canada - PCI Pharma Services

PCI Pharma Services
PCI Pharma Services
Verified Company
Mississauga, Canada

3 weeks ago

Sophia Lee

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Sophia Lee

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Description
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

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.

Provides oversight on validation projects and reports status of projects to the Quality Director.

Essential


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.

  • Generation of line trial protocols
  • Execution of line trials with the support of Tech Services or Maintenance as required.
  • Review and approval of executed line trials.
  • Works with the Technical Writer to ensure line trial learnings are captured in master production batch records.
  • Generation of IQ/OQ documents for new equipment.
  • Execution of IQ/OQ activities with the support of Tech Services or Maintenance as required.
  • Develop and recommend validation strategies for product portfolios.
  • Generation of PQ protocols. Provides training and support to production in the execution of PQ protocols.
  • Generation of PQ summary reports.
  • Provide technical assistance during investigations of process /equipment / cleaning / validation issues Identifies and tackles continuous improvement opportunities.
  • Reviews asset manuals and extracts relevant information to support technicians and PM requirement.
  • Support the development and review of equipment SOP.
  • Generate and resolve validation deviations / protocol discrepancies.
  • Support, investigate and troubleshoot problems and determine possible solutions.
  • Identify, respond and monitor potential project risk and determine possible contingency plans for risk mitigation.
  • Serve as a dependable technical liaison between Quality and Production.
  • Assist in reliability initiatives including investigation and implementation plan in support of the technical services team.
  • Represents the site as a member of the global validation center of excellence team.
  • Assists the validation specialist (as required) with the calibration and validation of equipment and systems.
  • Work on multiple projects and shift priorities as needed, track and update validation / client management on assigned projects.
  • Investigates, develops, and documents Deviation/Incident Reports related to validation runs with the guidance from the Quality Director.
  • Execution of mapping studies for warehouse and cold rooms as required. Assists in the review and approval of documents generated by the validation specialist.
Provides recommendations as required.

  • Consistently applies company SOP's relative to production, quality, and pharmaceutical standard.
  • Responsible for monitoring and adhering to GMP as well as Health and Safety Policies and Procedures; raises concerns or issues to the Quality Director.
  • This position may require overtime and/or weekend work. Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.
  • Attendance to work is an essential function of this position.
  • Performs other duties as assigned by Manager/Supervisor. Other duties as required.
Join us and be part of building the bridge between life changing therapies and patients.

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Equal Employment Opportunity (EEO) Statement:

  • PCI Pharma Services is an Equal _
  • Opportunity/Affirmative_
  • Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._
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