PharmEng Technology is currently seeking a Project Manager – Laboratory Testing Outsourcing
to join our team for projects in Ontario, CanadaJob Description:
- Develop Validation Plans, user Requirement specification, functional design specifications, risk assessment protocols, qualification protocols and analytical method transfer to different lab equipment
- Prepare and execute protocols for analytical laboratory equipment for analytical laboratory equipment such as (Karl Fisher Titrator, refractometer, and 21 CFR Part 11Compliant computerized systems including gas chromatography system including, FTIR and UV-VIS spectrophotometer )
- Develop and install an operational qualification summary reports
- Resolve non conformance for lab equipment such as gas chromatography and HPLC
- Prepare documents for analytical method transfer and analytical method validation
- Validation formulation process and cleaning process for formulation lab
- Summarize validation test results in final reports
- Responsible for other duties as assigned.
Thank you for your consideration and application! We review all resumes and submissions, however, due to the sheer volume of requests that we receive, only successful candidates will be contacted.
- Minimum of Bachelor’s Degree in Sciences or related field
- 6 years in Project Management including aspects of process development and execution.
- Experience at working both independently and in a team oriented, collaborative environment is essential.
- Can conform to shifting priorities, demand and timelines through analytical and problem-solving capabilities.
- Reacts to project adjustments and alterations promptly and efficiently.
- Ability to read communication styles of team members and contractors who come from a broad spectrum of disciplines.
- Minimum of 5 years of experience in laboratory equipment validation in pharmaceutical industry, such as HPLC, GAS chromatography, Karl Fisher Titrator, and Refractometer
- Knowledge and experience of SOP, GMPs, cGMPs
- Experience with Validation software
- Familiar with computer system validation
- Ability to write and execute protocols
- Familiar with 21 CFR Part 11
- Validation, lab equipment
- Quality management and techniques
- Strong communication skills both written and oral
- Ability to work in cross functional teams