R&d Quality Assurance Associate

**Title: R&D Quality Assurance Associate**
**Reports to: R&D Quality Assurance and Technical Documentation Manager**

The Research and Development (R&D) QA associate works under the guidance of the R&D Quality Assurance and Technical Documentation Manager. This position oversees all activities associated with the development of new products to ensure compliance to in-house and external specifications, standards, guidance such as cGMP, SOPs, ICH, Pharmacopoeias, FDA, EMEA, HC and ANVISA. Will require to provide internal guidance, support, risk assessment; and perform GMP/GLP training and Quality assurance training. Furthermore, this position will conduct vendor evaluation in all areas of R&D as required: suppliers, CMOs, CROs, clinical sites, etc.,
The R&D QA associate reviews and approves internal and supplier documentation related to product development, product submission, clinical supplies release, validation, change controls, etc., Also, performs impact assessment with respect to critical GXP such as GMP, GLP, GCP issues. This position is responsible for the final review of all data generated by the analytical development and formulation development teams prior to being attached to any development report or submission document.
This position performs activities required to meet company’s goals and objectives such as: documenting, reviewing, analysing and approving data in support of HC, FDA, EMEA and ANVISA submissions in a timely manner while complying with departmental SOP's and guidelines set out by the regulatory agencies and ICH (International Conference on Harmonisation). This will be achieved by working very closely with the analytical development and formulation development teams.

**Key job responsibilities and duties**:

- Supports the creation of Biolab’s Pharma Canada R&D quality management system
- Assists in the development and implementation of compliance activities in the R&D department in alignment with cGMPs, GLPs, GCPs, Biolab’s policies, SOPs and procedures.
- Performs self-inspection audits to ensure compliance of the R&D department as determined by R&D QA Junior Manager and Techinical Documentation.
- Might host, participate, support, conduct and lead audits when required to ensure Biolab’s R&D compliance to all required regulatory agencies and company’s policies.
- Leads and assists investigation of incidents during product development from a quality perspective.
- Reviews documents for compliance and approves regulatory documents to be filed in submissions such as analytical development reports, pharmaceutical development reports, stability reports, executed batch records, CofAs, clinical study reports, technical transfer protocols, technical transfer reports, validation documentation, etc.,
- Ensures all formulation development and analytical development activities meet good manufacturing practices, good laboratory practices and company’s policies.
- Performs data collection and analysis, discuss conclusions regarding progress of work, and effectively communicates information to peers and management in the form of presentations and reports.

**Education and experience requirements**:

- Canadian equivalent to Master of Science, PhD or Bachelor of Science degree, preferably in Pharmacy, Chemistry or Pharmaceutical Chemistry. Diploma/Degree/Certificate in Quality Assurance is preferred.
- More than two years of relevant hands on pharmaceutical Quality Assurance experience in product development. Demonstrates strong knowledge and experience of quality management systems in product development, clinical research and pharmacovigilance.
- Demonstrated ability to work independently or as a part of a team, and to coach less experienced colleagues.
- Highly motivated and have the skills to handle multiple projects and prioritize the work.
- Excellent communication skills (oral and written) and interpersonal skills are required

**Benefits**:

- Casual dress
- Dental care
- Employee assistance program
- Extended health care
- Flexible schedule
- On-site parking
- Vision care

Schedule:

- 8 hour shift

Application question(s):

- Currently lives in the GTA

**Education**:

- Bachelor's Degree (required)

**Experience**:

- relevant pharmaceutical quality assurance: 2 years (required)

**Language**:

- English (required)

Work Location: In person