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Laboratory Investigations and Documentation

2 weeks ago

Mississauga, Canada Biolab Pharma Full time

The laboratory Investigations and Documentation Specialist 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 (LE, LIR, OOS, OOT, unplanned and planned deviations) within analytical development (AD). The role also encompasses performing the impact assessment of the deviation, coordination of corrective actions and preventable actions with AD Manager, R&D QA Manager and any other employee required as part of the investigation. Moreover, this person authors, writes, reviews and maintains Analytical development documentation such as method development and method validation protocols and reports to ensure adherence to company’s goals and projects timelines.

This position requires working closely with the Analytical Development personnel and R&D Quality Assurance team, necessitating excellent communication and time management skills.

**Key Job Responsibilities**:

- Impartial investigator with the ability to conduct root cause analysis and utilize critical thinking when identifying and analyzing information accuracy and reliability.
- Perform activities to ensure compliance with applicable regulatory requirements as per ANVISA and Health Canada.
- Initiate, write and review LE, LIR, OOS, OOT and change control procedures for all deviations (planned and unplanned) within AD.
- Manage the LE and LIR database in the Analytical Development department to identify and analyze recurrence and trends arising from individual investigations.
- Conduct investigations and discuss with R&D QA the impact assessment on reported deviations.
- Coordinate immediate actions in conjunction with AD manager, AD Scientists and R&D QA personnel upon identification of a non-conformance
- Work with AD scientists and R&D QA to develop appropriate CAPA actions
- Write, review and update SOPs
- Write, review method development and method validation protocols and reports as required.
- Manage the AD database for Methods, Specs, Stability protocols and reports and validation protocols and reports
- Perform data collection required for management reviews, KPI reports, and other AD review mechanisms such as project timelines, instrument usage, etc.
- Ensure all documentation is completed in a timely and accurate manner in accordance with Biolab’s SOPs, GMP guidelines and ANVISA’s and Health Canada requirements.
- Any other responsibilities as assigned by management.

**Education and experience requirements**:

- Canadian equivalent to Bachelor of Science or Master of Science degree, preferably in Pharmacy, Chemistry or Pharmaceutical Chemistry.
- More than three years of relevant hands-on Canadian pharmaceutical experience.
- Understanding of analytical equipment, such as GC, LC/MS, HPLC, UV and automated dissolution systems is essential.
- Experience with root cause investigation tools, risk-based assessment tools and Chromeleon software is preferred.
- Demonstrated ability to work independently and as a part of team.
- Highly motivated and have the skills to handle multiple projects and prioritize the work.
- Excellent communication skills (oral and written) and people skills are required.

**Job Types**: Full-time, Permanent

**Benefits**:

- Casual dress
- Dental care
- Extended health care
- Flexible schedule
- Life insurance
- On-site parking
- Vision care

Schedule:

- 8 hour shift
- Day shift
- Monday to Friday
- No weekends

Ability to commute/relocate:

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

Work Location: One location