Dalton Pharma Services is a leading provider of integrated pharmaceutical discovery, development and manufacturing services to the biotechnology and pharmaceutical industries. We develop and manufacture innovative new products on a contract basis for our customers that bring enhanced therapeutic value and impact the lives of the patients that use them. Our customers range from the largest global pharmaceutical companies in the world to the smallest startup company. Dalton offers industry leading expertise in chemical synthesis, API production, formulation development and the manufacturing of sterile injectable products, all supported by extensive in-house analytical and quality support.
This posting reflects the coverage of an existing vacancy within our organization.
Responsibilities:
- Perform all GMP activities, as applicable to duties, in compliance with GMP guidelines and Dalton SOPs.
- Write and review Standard Operating Procedures (SOPs), as needed.
- Follow up and ensure completion of periodic reviews of SOPs and other GMP documents.
- Review Change Controls and ensure they are implemented in a timely and effective manner.
- Review of Vendor Qualification and Service Provider Qualification documents.
- Review of Calibration / Performance Verification / Preventive Maintenance records and certifications.
- Issue the logbooks and other documents to the user departments.
- Review logbooks for compliance and completion, as needed.
- Ensure that employees follow Good Documentation Practices on all documents and maintain compliance.
- Ensure that documents in use have been properly reviewed and approved, meet the GMP requirements and are current.
- File the completed logbooks and other documents appropriately for easy retrieval.
- Ensure the proper archiving and retention of documents and records as per GMP requirements.
- Update the QA database and associated QA logbooks, as needed.
- Retrieve and provide the documents, as needed.
- Provide document support during regulatory inspections and client audits.
- Prepare Annual Product Quality Reviews (APQR) and Quality System Trend Reports.
- Personnel Training – co-ordination of training activities such as SOP training
- Administrative functions – attend meetings, timesheets, scanning and copying of documents for clients, etc. and other activities, as assigned.
- Performs other related duties as required.
Qualifications:
- B.Sc. or higher degree in Pharmaceuticals, Chemistry, Biochemistry or Microbiology
- or 3+ years of Quality Assurance and Compliance experience in the pharmaceutical industry in a GMP environment, with knowledge of the Canadian GMPs, US cGMP’s, and EU GMPs requirements
- Health Canada, FDA, EU GMP, and ICH guidelines and strong verbal and written communication skills
- Experience in handling and managing quality documentation and the electronic Quality Management System (EQMS)
- and/or electronic Document Management System (EDMS) would be an asset.
Job Type: Contract
Pay: $25.00-$28.00 per hour
Application question(s):
- Are you comfortable working 100% on-site?
Education:
- Bachelor's Degree (preferred)
Experience:
- Pharmaceutical Quality Assurance and Compliance: 3 years (preferred)
- Canadian GMPs, US cGMP’s, Health Canada, FDA: 3 years (preferred)
Work Location: In person
