Title: Junior Associate, R&D; Quality Assurance (12 Months Contract)

Reports to: Senior R&D; Quality Assurance Manager The Research and Development (R&D;) QA junior associate works under the guidance of the Senior R&D; Quality Assurance Manager and R&D; QA Associates. This position assists to oversee 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 technical documentation internal guidance, support, risk assessment; and perform GMP/GLP training and Quality assurance training.

The R&D; QA junior associate under the guidance of the Senior R&D; Quality Assurance Manager will review and approve internal and supplier documentation related to product development, product submission, clinical supplies release, validation, change controls, etc., Also, R&D; QA junior associate performs impact assessment with respect to critical GXP such as GMP, GLP, GCP issues. This position supports R&D; QA final review of all data generated by the analytical development, formulation development and calibration teams prior to being attached to any development report or submission document. This includes the review of calibration records and qualification documentation such as IQ (Installation Qualification), OQ (Operational Qualification) and PQ (Performance Qualification).

This position performs activities required to meet company’s goals and objectives such as: documenting, reviewing, analyzing 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 Harmonization). This will be achieved by working very closely with the analytical development, formulation development and calibration teams.

Key job responsibilities and duties:

- 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.
- Supports self-inspection audits to ensure compliance of the R&D; department as determined by the Senior R&D; Quality Assurance Manager.
- 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, calibration records, IQ/OQ/PQ documentation and related qualification reports, etc.
- Ensures all formulation development, analytical development and calibration activities meet good manufacturing practices, positive laboratory practices and company policies.
- Performs data collection and analysis, discusses conclusions regarding progress of work,



and effectively communicates information to peers and management in the form of presentations and reports.
- Provides technical documentation expertise to format SOPs, development reports and all other specified documentation as per Biolab's standards.

Education and experience requirements:

- 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 experience as a pharmaceutical document writer.
- More than one year of relevant hands on pharmaceutical Quality Assurance experience in product development. Demonstrates knowledge and understanding of quality management systems in product development. Demonstrated ability to work independently or as a part of a team.
- Experience working with Electronic Quality Management Systems (eQMS) and Computer Software Validation (CSV) is considered an asset.
- Highly motivated with the ability to handle multiple projects and prioritize work effectively.
- Excellent communication skills (oral and written) and interpersonal skills are required.​

‌We are currently hiring for an existing vacancy. Job Types: Full-time, Fixed term contract

Pay: Up to $54,000.00 per year

Benefits

- Casual dress
- Dental care
- Disability insurance
- Extended health care
- Flexible schedule
- Life insurance
- Vision care

Application question(s):
- Currently Resides in the GTA

Education:
- Bachelor's Degree (required)

Experience:
- relevant Pharmaceutical Quality Assurance: 1 year (required)

Language:
- English (required)

Work Location: In person

📌 Quality Assurance Junior Associate (12 month contract) (Mississauga)
🏢 Exzell Pharma
📍 Mississauga