R&d Data Reviewer

1 week ago

Mississauga, Canada Biolab Pharma Ltd Full time

**Job Opportunity**

**Position Title**: R&D Data Reviewer - Analytical Development
**Reports To**: R&D QA & Technical Documentation Manager

**Position Summary**

The R&D Data Reviewer - Analytical Development plays a critical role in supporting the development of new pharmaceutical dosage forms and enhancing existing products and procedures. This position is responsible for independently reviewing analytical data generated during method development, transfer, verification, and validation, as well as data from chemical and physical testing of raw materials, in-process samples, finished products, and stability studies. The role ensures data integrity and compliance with regulatory standards to support product development and GMP supply release.

**Key Responsibilities**
- Review analytical data to ensure accuracy, completeness, and compliance with cGMP and data integrity standards.
- Evaluate raw data from testing of raw materials, in-process samples, and finished products to ensure product quality and efficacy.
- Review data related to analytical method development, transfer, and validation.
- Assess test methods, validation protocols, and reports for scientific soundness and regulatory compliance.
- Perform peer reviews of laboratory notebooks and data generated by analytical development personnel.
- Review documentation related to equipment qualification, maintenance, and calibration.
- Support the preparation of regulatory submission documentation.
- Identify opportunities for continuous improvement in analytical processes and documentation practices.
- Ensure all activities comply with internal SOPs, cGxP, regulatory requirements, and safety/environmental guidelines.
- Collaborate on internal and external (CMO) projects aligned with Biolab’s strategic objectives.
- Participate in or lead laboratory investigations and change control processes.
- Assist in preparation for internal and regulatory inspections.

**Qualifications**
- Bachelor’s or Master’s degree (Canadian equivalent) in Pharmacy, Chemistry, Pharmaceutical Chemistry, or a related scientific discipline.
- Minimum of 2 years of hands-on pharmaceutical experience in product development.
- Proficient in operating analytical instruments such as HPLC, UV/Vis, GC, and dissolution apparatus.
- Solid understanding of DOE, risk-based assessment tools, QbD, method validation, equipment troubleshooting, and tech transfer.
- Experience with Chromeleon software is an asset.
- Strong ability to work independently and collaboratively in a team environment.
- Excellent organisational, communication (oral and written), and interpersonal skills.
- Ability to manage multiple priorities and meet deadlines in a fast-paced environment.

Pay: Up to $65,000.00 per year

**Benefits**:

- Casual dress
- Dental care
- Disability insurance
- Employee assistance program
- Extended health care
- Flexible schedule
- Life insurance
- On-site parking
- Paid time off
- RRSP match
- Tuition reimbursement
- Vision care

**Education**:

- Bachelor's Degree (required)

**Experience**:

- Pharmaceutical Analytical Development: 2 years (required)

Work Location: In person

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