Ambicare Canada is a fast-growing Canadian Generic Pharma company and an associate of Ambica International Corporation, part of the 75+ year old Unilab Group, Philippines.
As we expand our product portfolio, we are looking for experienced senior quality Assurance Associate.
The Senior Quality Assurance Associate is responsible for ensuring that all current products are in compliance with Health Canada regulations related to Quality and Pharmacovigilance. The senior QA Associate will report directly to the Vice-President Regulatory Affairs and Quality Assurance, and also support internal management as needed.
The responsibilities include:
- Maintain the DEL and Site License for Ambicare Pharmaceuticals Inc.
- Assist with gathering and maintenance of Foreign sites documentation, and submission onto DEL.
- Prepare and participate quality inspections from Health Canada, and internal audits as required, and execute the necessary corrective actions
- Ensure all HC requirements and deadlines are met as it relates to annual drug notifications, and DEL renewals.
- Maintain Standard Operating Procedures; Review of documentation for GMP purposes
- GMP responsibilities - including but not limited to leading investigations, reviewing and approving deviations and change controls, batch release and all associated quality assurance requirements.
- Evaluate complaint reports for accuracy and work with the Pharmacovigilance provider to ensure compliance with procedures.
- Maintain all documents – such as: Batch Records, Master Manufacturing and Packaging Records, specifications, stability, quality agreements, APQRs, annual quality system requirements.
- Ensure that product labelling, package inserts and product monograph are accurate and compliant
- Preparation of Finished Product Release
- Assist in the development of procedures and processes to ensure compliance with the Food and Drug Act and Regulations, as needed
- Oversee Pharmacovigilance provider and documentation, ensuring compliance with PV SOPs.
- Work with internal team and external oversees team to provide support as needed.
- Ability to interpret scientific data and information
Skills & Qualification
The successful candidate is a highly motivated, enthusiastic and dynamic team player who is resourceful and dedicated and has competencies in adapting to changing environments.
Educational Qualification and Experience requirement
Canadian University Science Degree or degree recognized as equivalent by a Canadian University or Accreditation body in Sciences with at least five years of previous QA experience in a pharmaceutical regulated environement out of which at least three year QA experience in Canadian Pharma organization.
Competencies:
Thorough understanding of Canadian GMP and GVP requirements, including interpretation of the Food & Drug Act and Regulations and a working knowledge of ICH requirements.
Good working knowledge of Canadian GMPs. Strong understanding of quality management systems (QMS) including product release, document management, change control, investigation and CAPAs. Good working knowledge of Canadian Pharmacovigilance requirements.
Applies good document management practices.
Proficient computer skills, which would include Microsoft Office (Word, Excel, Outlook)
Excellent communication skills (written and oral)
Strong Project Management skills
Superior organizational skills, with the ability to prioritize and handle multiple tasks and deadlines, works well under pressure and has a sense of urgency
Possess excellent attention to detail and have the ability to manage time and complex QA, and PV projects.
- Self-starter who is able to work independently with minimal supervision. Good communication skills are very important.
Pay: $70,000.00-$75,000.00 per year
Benefits:
- Dental care
- Extended health care
- On-site parking
Ability to commute/relocate:
- Oakville, ON: reliably commute or plan to relocate before starting work (required)
Education:
- Bachelor's Degree (required)
Experience:
- Canadian Pharma : 3 years (required)
Work Location: In person
