Job Description

The

Research and Development (R&D)

QA and Technical Documentation Associate Manager is responsible for the compliance to in-house and external specifications, standards, guidance such as GMP, SOPs, ICH, Pharmacopoeias, FDA, EMEA, HC and ANVISA required for an

R&D centre

. This position is also responsible for the ongoing development and maintenance of the Quality Management System within Biolab Pharma Canada

R&D

centre, providing internal guidance, support, risk assessment, GMP/GLP training, Quality assurance training and conduct when required vendor evaluation in areas of R&D: suppliers, CMOs, CROs, clinical sites, etc.,

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 together with all teams within the organization, including the analytical development and formulation development teams.

Key job responsibilities and duties:

Maintenance of Biolab's Pharma Canada

R&D

quality management system Develops and ensures the implementation of compliance activities in the

R&D

centre in alignment with cGMPs, GLPs, GCPs, Biolab's policies, SOPs and procedures. Provides guidance to the areas within the department: Compliance and Data Reviewers, to meet company's goals within specified timelines. Performs self-inspection audits to ensure compliance of the

R&D

centre according to GUI-0036. Hosts, participates, supports, conducts and when required leads audits to ensure Biolab's

R&D centre

is compliantto all required regulatory agencies and company's policies for an

R&D facility

. Leads investigation of incidents during product development from a quality perspective. Reviews documents for compliance and approves documents to be filed in submissions such as analytical development reports, stability reports, executed batch records, CofAs, 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 as per GUI-0036. 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. Fosters an environment of collaboration with all teams within the

R&D

centre, understanding Health GMP guidelines GUI-0036, and performing adequate risk based management approach for an

R&D

facility.
Job Types: Full-time, Permanent

Pay: Up to $93,000.00 per year

Additional pay:

Bonus pay
Benefits:

Casual dress Dental care Employee assistance program Extended health care Flexible schedule On-site parking Paid time off RRSP match Vision care
Flexible language requirement:

French not required
Schedule:

8 hour shift Monday to Friday
Education:

Bachelor's Degree (required)
Experience:

PHARMACEUTICAL R&D QA: 8 years (required)
Language:

English (required)
Work Location: In person