Quality Assurance and Regulatory Affairs Associate

4 days ago

Mississauga, Canada Septa Pharmaceuticals Inc. Full time

Septa Pharma Inc., is proudly a Canadian owned and operated Pharmaceutical Company based in Mississauga, Ontario. Our Mission is to provide quality pharmaceutical and healthcare products to advance and nourish the quality of life in domestic and global markets.

We are excited to announce the opening for the position of **Quality Assurance and Regulatory Affairs**. Working to support operations and to ensure compliance as related to pharmaceutical products and regulations, the incumbent will principally be responsible for managing all Quality Assurance and Regulatory responsibilities as well as oversee the drafting and implementation of Standard Operating Procedures (SOPs) related to QMS.

The incumbent **must** have knowledge of **Health Canada, DIN/NHP Guidelines, DEL requirements, Medical Devices, Clinical Trials, Knowledge of provincial formularies.**

The Quality Assurance (QA) & Regulatory Affairs(RA) person will be responsible for all QA & RA functions including, but not limited to batch/lot record review and release, raw data review, deviation/failure investigation, change evaluation, product sampling, and retention as it relates to Drugs, Natural Health Products, Medical Devices and Cosmetics that are imported and/or distributed by the company in Canada and Globally.
- Conduct a review of and track Good Manufacturing Practices (GMP) documentation, including Master Batch Records, Master Packaging Records, Certificates of Analysis, Annual Product Quality Reviews, Stability, etc., for products imported and marketed.
- Performs all QA functions including, but not limited to: batch/lot record review and release, raw data review, deviation/failure investigation, change evaluation, product sampling, and retention.
- Reviews production and laboratory records, assisting in internal audits and self-inspections.
- Supports in the development of SOPs to ensure efficient and compliant Quality function.
- Perform Quality Control duties as stated in the Standard Operating Procedures on Quality Control.
- Ensure that all medical device, drug, natural health product and cosmetic products released is of intact product integrity.
- Liaise with the suppliers of medical device and/or drug and/or natural health and/or cosmetic products.
- Liaise with third party Quality and Regulatory Designate.
- Reviews regulatory documentation and submissions to regulatory bodies including, but not limited to: Drug Establishment Licenses, and Site Licenses/registrations.
- Supports all quality related exportation requirements as a QPIC (Qualified person in charge)

**Minimum Requirements**:

- 5+ Years of experience in compliance, quality assurance, regulatory affairs, and document management in the pharmaceutical or prescription drug industry or equivalent
- Must have led Health Canada Audits
- Experience in an environment adhering to federal governmental regulation (Health Canada / USFDA) is required
- **Strong GMP pharma/ Qualified Person in Charge (QPIC) **experience is required
- **Prior experience interacting with auditors and regulators is required**:

- Experience in document control and management is required
- Experience with preparing regulatory submissions is required
- Knowledge of ANDS submissions is preferred
- **Knowledge of NHP submissions is a must**

**Salary**: $40,000.00-$55,000.00 per year

**Benefits**:

- Extended health care

Schedule:

- 8 hour shift

Supplemental pay types:

- Bonus pay

Ability to commute/relocate:

- Mississauga, ON: reliably commute or plan to relocate before starting work (required)

**Education**:

- Bachelor's Degree (required)

**Experience**:

- Quality Assurance and Regulatory Affairs: 3 years (required)

**Language**:

- English (required)

Licence/Certification:

- Quality Assurance Education (Diploma/Degree) (required)

Work Location: One location

Expected start date: 2023-01-25

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