Validation Analyst

6 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.

JOB SUMMARY

Responsible for planning, executing and leading various validation project assignments. Including execution of line trials, 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
- Generation of line trials (engineering 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.
- 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.
- 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
- Undertakes the calibration and validation of equipment and systems.
- Assists the technical services department with annual equipment evaluation based on trending of data from PM etc. to proactively address potential issues with equipment.
- 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 Sr. QA Manager
- Execution of mapping studies for warehouse and cold rooms as required.
- Management of site Pest Control program
- Logging of PM activities in the PM database
- Execution of cleaning validation studies, including protocol generation and summary
- Consistently applies company SOPs relative to production, quality and pharmaceutical standards.
- 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
- Other duties as required.

SKILLS, KNOWLEDGE / EXPERIENCE REQUIRED TO PERFORM THE JOB
- BSc in engineering or related scientific field, engineering preferred.
- 3-5 years' experience with pharmaceutical manufacturing and/or packaging an asset.
- In-depth knowledge of GMP’s.
- Exceptional attention to detail and accuracy in the maintenance of records and data.
- Excellent organizational and time management skills to ensure deadlines are met.
- Effective interpersonal and teamwork skills.
- Able to problem solve
- Extensive computer knowledge and adeptness with various software programs including Microsoft Office and database management.
- Excellent English language written and oral communication skills.
- Able to oversee multiple project assignments, direct daily activities and provide on the job training to employees.

SUPERVISION

Reports to the Sr. Director, Quality Operations and Global Strategy Partner. Works within an established work schedule based on production needs.

LI-KH1

Join us and be part of building the bridge between life changing therapies and patients.

Let’s talk future

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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