Qc Laboratory Supervisor

7 months ago

Windsor, Canada Pancap Pharma Full time

Pancap Pharma Inc. is a leader in specialty contract manufacturing of pharmaceutical dosage forms. The company began its contract manufacturing operations in January of 1994 and since then has translated experience into quality production for a wide range of clients.

From concept to full package delivery, we have the experience and commitment to meet the needs of even the most unique clients. We offer a wide range of manufacturing and support capabilities including capsule fabrication, compounding of non-sterile liquids, packaging, labelling, regulatory affairs, testing and quality assurance. The products we manufacture are then shipped around the world. Quality is the cornerstone upon which Pancap has built its foundation. Our Quality Assurance System was developed in order to ensure the production of safe and effective products in compliance with the current Good Manufacturing Practice (cGMP) regulations, industry standards and our client's specifications/marketing requirements.

We are growing our operations with a brand-new state of the art facility in **Windsor, Ontario** and we are looking for a contract QC Laboratory Supervisor

**ROLE AND KEY REPSONSIBILITIES**

**QC SUPERVISOR WINDSOR**
- Always respects and adheres to company policies.
- Adhere to Health and Safety Policy
- Perform all work in accordance with cGMP and approved procedures to ensure the technical integrity and regulatory compliance of all data generated.
- Check results for accuracy and ensure compliance to cGMP/GLP and SOP’s
- Good understanding of test procedures and basic analytical principals
- Able to operate laboratory instrumentation such as: UV/IR Spectrophotometers, Dissolution Apparatus, TOC, pH Meter, Conductivity Meter, Auto-Titrator
- Identifies simple technical problems related to instruments operation and solves as necessary.
- Identifies preventable errors prior to the start or completion of the test and report as appropriate.
- Applies the knowledge gained previously in the lab to improve the quantity and quality of work.
- Organizes work efficiently and utilizes time efficiently.
- Completes documentation as soon as testing is done and review data for completion and accuracy prior to handing in for review.
- Recognize and report OOS/OOT results in a timely manner.
- Issue Non-Conformance/Non-Impact Notices/OOS/OAL or Change Request as needed.
- Schedule/perform validation and transfer of test methods and production processes.
- Takes responsibility and accountability for the duties assigned.
- Able to work independently and within a team environment. Actively participate in team related tasks. Support the team on meeting deadlines.
- Participate in on-going training as required and complete training in specified time frame.
- Ability to work shift work or longer hours when required.
- Communicates any potential delay for the projects assigned in a timely manner.
- Sample and test all Raw Materials according to current SOP’s / Methods and within GMP compliance.
- Sampling and Testing of Packaging components.
- Provide production support during processing and packaging.
- Monitoring of Airflow patterns and pressures in Production Areas
- Monitoring temperatures throughout the facility
- Calibration of Test Equipment
- Environmental Microbial Sampling and Scheduling
- Testing and result evaluation of Stability Product
- Weekly water testing utilizing TOC and Conductivity meter.
- Manage Calibration of Test Equipment
- Perform investigations into customer complaints/inquiries.
- Lead Quality Control Group on Data Integrity
- Schedule day to day activities of QC Laboratory, while maintaining appropriate productivity and quality matrices.
- Provide ongoing training to all QC Laboratory employees in all relevant SOP’s, test methods, analytical equipment and proper laboratory techniques.
- Manage the quality requirements for Laboratory Equipment qualifications, calibrations, and troubleshooting.
- Ensure deviation investigations are performed to completion and that CAPA is performed.
- Ensure testing is performed accurately and in compliance with GLP, GMP, USP, SOP, EP and approved test methods.
- Develop, improve and validate laboratory test methods.
- Ensure all testing, validation and development studies are carried out in accordance with cGMP and internal SOP’s.
- Review of Notebook, Logbooks, and Analytical Specifications
- Arrange samples to be sent and tested by contract testing labs.
- Review of test results from contract labs
- Review and if necessary, revise Standard Operating Procedures
- Other duties as assigned.

**QUALIFICATIONS AND EXPERIENCE**
- University Degree or College Diploma in a science related field
- 3 years Quality Control experience preferred.
- Experience in a pharmaceutical laboratory environment preferred.
- Good knowledge of laboratory GMP and demonstrated proficiency in analytical techniques.
- Works well in a fast-paced environment both individually and as part of a team.

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