Quality Assurance/ Regulatory Affairs Manager

2 months ago

Whitby, Canada Tanta Pharmaceuticals Inc. Full time

**POSITION**: Quality Assurance/Regulatory Affairs Manager

**INDUSTRY**: Pharmaceutical

**STATUS**: Permanent Position Full Time Position

**LOCATION**: Whitby, On.

**SALARY**: Competitively structured

**Company overview**: Tanta Pharmaceuticals Inc. is a leading provider of OTC pharmaceutical and healthcare products in Canada. At Tanta we believe that each employee contributes directly to the growth and success of the company and we want our employees to take pride in being a member of our team.
Through our commitment to service and our proven business model, we at Tanta pride ourselves in providing affordable alternatives to brand name pharmaceuticals and healthcare products supplying major chain drugstores across Canada.

Tanta Pharmaceuticals Inc. currently has a permanent full time position available at our head office in Whitby, Ontario. We are seeking a **Quality Assurance/Regulatory** **Affairs Manager**, who will be responsible for the oversight of all QA activities including but not limited to:

- Provide leadership and direction for the development and implementation of robust Quality Systems
- Provide strategic direction regarding processes, procedures and quality standards required to maintain compliance to applicable regulations.
- Review and approve Canadian printed packaging components, master labels, and artwork.
- Manage and investigate product complaints and pharmacovigilance activities.
- Work in collaboration with Packaging Operations and other stakeholders to ensure compliance with applicable SOPs, regulations and guidance documents.
- Ensure an “inspection ready” state is maintained across all GMP activities.
- Ensure development and refinement of internal SOPs applicable to GMP functions.
- Manage audits (internal and external) to assure adherence to company SOPs and all applicable regulatory requirements.
- Ensure that appropriate corrective actions are taken as a result of audit or inspection observations.
- Manage quality oversight of contracted drug substance and drug product manufacturing operations.
- Manage the stability program, review stability data and ensure that the stability tests are completed on time.
- Manage activities relating to batch record review and release, laboratory document review and release, product investigations, quality investigations and annual product reviews.
- Approve, or oversee review and approval, on all processes, qualifications and validation reports, change control documents and technical reports.
- Perform formal risk assessments internally, as well as with selected contract providers; determine audit intervals and establish level of risk based on this assessment.
- Develop and manage personnel overseeing quality and compliance, provide SOP and GMP training and manage training records.
- Act as point of contact for on-site regulatory inspections and audits ensuring successful completion of health authority inspections
- Maintains / renewal of product licences for drug, site, precursors, medical device and small business status
- Submission of artworks / DIN / New products / New suppliers to Health Canada for approval

**QUALIFICATIONS**:

- Minimum B.Sc. degree in a scientific discipline, equivalent or Pharmacy.
- Minimum 7 to 10 years experience in a management or supervisory role in the pharmaceutical industry in the areas of quality assurance, quality control and regulatory compliance, preferably in North America.
- Excellent knowledge of Health Canada regulatory requirements pertaining to laboratory analysis and manufacturing procedures.
- Experience in regulatory and third party inspections.
- Experience in full product cycle for the purposes of designing, building of phases for quality checkpoints, planning and execution of product testing efforts including accountability of deliverables and quality output.
- Proven track record of ongoing quality improvement process including the development of QA metrics for performance improvement.
- Excellent leadership, organizational and time management skills, with the ability to multi task.
- **Exemplary verbal and written communication skills and high proficiency with the English language**.
- Intermediate to advance knowledge of MS word, Excel, Adobe Acrobat standard, MS outlook and power point.
- Project Management skills including prioritization, time management, and multi tasking skills.
- Ability to maintain a high level of accuracy and attention to detail.
- Excellent problem solving and decision making skills

We are committed to diversity and inclusion, and thank all applicants in advance; however, we will be corresponding only with those selected for interview.

**Job Types**: Full-time, Permanent

**Salary**: $90,000.00-$105,000.00 per year

**Benefits**:

- Casual dress
- On-site parking

Schedule:

- 8 hour shift
- Day shift
- Monday to Friday

COVID-19 considerations:
Personal Protective Equipment provided or required
Social distancing guidelines in place
Sanitizing ,disinf

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