Quality Assurance Coordinator

4 weeks ago

Toronto, Canada Produtos Full time

Nordic Pharma is a mid-size privately-owned international pharmaceutical company which focuses on the development and commercialization of niche hospital and orphan products to address unmet medical needs. Nordic Pharma’s expertise relies on the development and sales of its own products, but also on partner products acquired at various stages of development. Today, Nordic Pharma has a range of highly specialized proprietary and inlicensed products in the following therapeutic areas: Rheumatology, Women’s Health and Critical Care (Anaesthesia, Haematology, Oncology).

Nordic Pharma’s values of Commitment, Ambition, Respect, Reliability, Integrity and Agility describe our culture and standards and guide us in our way of working.

JOB TITLE: Quality Assurance Coordinator

DEPARTMENT: Quality Assurance

REPORTING TO: Manager, Quality and Supply Chain

LOCATION: Toronto, ON

General summary of role:

- Manage and perform tasks to ensure Celopharma Drug Establishment license is kept current
- Perform review and approvals for critical Quality documents
- Perform drug product review and releases
- Management of critical quality management systems (Change Control, Complaint and Deviation process; CAPA process)
- Electronic Data Management Systems-local coordinator for training, management of rights, document creation, main point of contact with corporate and Nordic AAP employee)

Essential responsibilities and tasks:

- Manage the Drug Establishment License filing and updating process for Celopharma Inc.
- Provide QA Support in the creation, review of change controls; complaint and deviation processing; APQR reviews; Drug Product Batch Releases
- Perform batch record review of incoming imported drug products
- Requesting GMP documents from Corporate QA team and/or fabricators to comply with GUI0001
- Liaison with local warehouse regarding the proper storage of drug product; inspection and retention of samples; returns/destruction; and other quality requirements regarding the drug products
- Write QA SOPs as required
- Support Celopharma QA in regulatory authority inspections
- Evaluation of fabricator Product Quality reports
- Summarize Canadian data to complete local Annual Product Review Reports
- Preparation of Quality Distribution Agreements
- Liaise with Business Partners to address non-conformances (ie. product complaints) within their respective territory

Qualifications, experience and skills required:

Knowledge and training requirements:

Work experience requirements:

- Minimum 2 years experience with quality assurance work experience in a pharmaceutical organization

Expected professional skills:

- Capable of managing tight project timelines when required. Works well with minimal supervision
- Possess good judgement and decision-making skills
- Maintains professionalism at all times
- Excellent communication skills (verbal and written)
- Willingness to continue to educate self on new technologies; policies; guidelines and implement the best practices
- Possesses the educational and technical skills required for the position
- Is adaptable; flexible and creative. Have a great work ethic
- Capable of dissecting complex situations and problem-solve

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