Job Overview
The Laboratory Investigations and Documentation Specialist Formulation Development supports the development of new pharmaceutical dosage forms in addition to improving existing products and procedures. This person is responsible to follow Biolab’s SOPs for the creation, initiation, investigation, writing, completion and control of all deviation’s reports, (unplanned and planned deviations) within Formulation development (FD). The role also encompasses performing the impact assessment of the deviation, coordination of corrective actions and preventable actions with FD Manager, R&D QA Manager and any other employee required as part of the investigation.
Moreover, this person authors, writes, reviews and maintains Formulation Development documentation such as formulation development templates, forms, technical documents, master batch records, master manufacturing formulas and packaging work orders to ensure adherence to company’s goals and projects timelines. Furthermore, this position also supports the final review of documents generated by the formulation development team prior to being attached to submission dossiers intended to Regulatory Agencies such as Health Canada, FDA, EMEA, ANVISA, etc.,
This position requires working closely with the Formulation Development and Analytical Laboratory personnel and R&D Quality Assurance team, necessitating excellent communication and time management skills.
Responsibilities
- Impartial investigator with the ability to conduct root cause analysis and utilize critical thinking when identifying and analyzing information accuracy and reliability.
- Performs work with a high degree of accuracy and quality to ensure compliance with applicable regulatory requirements while working under tight deadlines.
- Initiate, write and review change control procedures for all deviations (planned and unplanned) within FD.
- Conduct investigations and discuss with R&D QA the impact assessment on reported deviations.
- Coordinate immediate actions in conjunction with FD manager, FD Scientists and R&D QA personnel upon identification of a non-conformance
- Work with FD scientists and R&D QA to develop appropriate CAPA actions
- Authors documents, templates, forms to support drug product development activities within the FD department.
- Write, review and update SOPs.
- Reviews FD documents for formatting / accuracy and liases with scientists to evaluate development strategy rationale /justification for pharmaceutical development reports, stability reports, executed batch records, CofAs, technical transfer protocols, technical transfer reports, etc.,
- Write and Review Formulation Develoment protocols and reports as required.
- Performs data collection and analysis, discuss conclusions with FD teams 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 three years of relevant hands on pharmaceutical experience. Knowledge and experience of regulatory and GMP requirements in product development. Direct knowledge of solid dosage manufacturing processes and/or analytical techniques requirements is preferred.
- Strong proficiency with Microsoft Office applications (Word, Excel, PowerPoint, Access) and Adobe Acrobat Professional
- 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 with the ability to explain complex concepts with clarity and simplicity.
Job Types: Full-time, Permanent
Pay: Up to $64,000.00 per year
Additional pay:
Benefits:
- Casual dress
- Dental care
- Employee assistance program
- Extended health care
- Life insurance
- On-site parking
- Paid time off
- RRSP match
- Vision care
Flexible language requirement:
Schedule:
- Day shift
- Monday to Friday
Education:
- Bachelor's Degree (required)
Experience:
- hands-on Canadian pharmaceutical industry relevant: 3 years (required)
Language:
Work Location: In person
