QC Associate – Specifications & Testing
PNP Pharmaceuticals is currently seeking for a QC Associate – Specifications & Testing to join our Quality Control team.
- 9:00am to 5:00pm, Monday to Friday
Principal Duties and Responsibilities:
- Prepare raw material, packaging material, bulk and finished product specifications following approved monographs, manufacturers specifications, clients and PNP requirements (i.e. either in a paper based or electronic system).
- Complete raw material and packaging material files for vendor approval process to ensure that raw materials and packaging components meet all regulatory and industry requirements.
- Follow-up on test results with contract test laboratories in relation to Sample Analysis Requests (SARFs) or any other type of lab submission forms.
- Review of test results against requirements/specifications as per SARFs/lab submissions forms; gather test results and suppliers’ Certificate of Analysis (C of As) for QC release.
- Prepare raw material, packaging material, bulk and finished product testing sheets by adding the test results for Quality Managers approval where applicable (i.e. either on a paper-based system or electronic system).
- Assist in the investigation of OOS results.
- Prepare reports, such as but not limited to OOS, Deviations and CAPA.
- Assist in the review of Manufacturing and Packaging Batch Records.
- Review of invoices from contract test laboratories and provide feedback on test charges.
Additional Duties and Responsibilities:
• Perform routine tests such as pH, moisture, gluten, flow, DT, bulk density, etc.
• Other duties that may be assigned.
• Offer suggestions for process improvement when identified.
• Support the QA/QC department, as needed.
Qualifications and Requirements:
- Science related diploma in a related field as Chemistry, Pharmacy, or Biology.
- Minimum 1 year of experience in a supervisory role or experience leading a team is an asset.
- Has practical experience in area of responsibility – Analytical Test Methods (USP, NF, AOAC, EP, etc.) and Instrumentation such as HPLC, ICP, GC, UV, IR, etc.
Knowledge, Skills and Abilities:
- Minimum 1 to 3 years of experience in related field is preferred.
- Trained in Good Manufacturing Practices (GMP).
- Good computer skills: proficient in MS Office.
- Extreme attention to detail.
- Ability to work independently and in a team.
If you are interested in this position, please apply send us an email at email@example.com with your resume and subject title: “QC Associate – Specifications & Testing”
We thank all applicants in advance for your interest in PNP Pharmaceuticals, but only shortlisted candidates will be contacted for an interview.