Under guidance of Supervisor or senior chemist, responsible for performing all activities in ARD-Test Centre including method validation for recent products, full testing of API, in-process and finished dosages, and generates regulatory submission documentation. Acts as a key member in the project working team.
Job Responsibilities
- Performs validation of analytical testing procedure for drug substance and drug product.
- As per specifications, performs initial testing as well as testing of stability samples, in-process and raw materials.
- Conducts other tests required for dosage submissions.
- Documents and reports results as per established SOP s.
- Provides technical support to other department in response to deficiency letters from regulatory agencies.
- Works in a safe manner collaborating as a team member to achieve all outcomes.
- Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
- Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety, Health and Environment policies, and HR policies.
- Liases at peer levels within RD solid dosage to obtain a more in-depth level of expertise and to understand their needs.
- Refers more contentious issues, with recommendations, to Supervisor
- Performs all work in accordance with all established regulatory, compliance and safety requirements.
- Ensures all advice given to internal contacts and the complex decisions made at this level are compliant.
- All other relevant duties as assigned.
Job Requirements
- Education
- A graduate/postgraduate degree in Chemistry/ Pharmacy from a recognized school/university.
- Knowledge, Skills and Abilities
- Knowledge of wet chemistry, analytical bench techniques, Window-based software.
- Knowledge of automated data acquisition systems is an asset.
- Knowledge of Auto/Manual dissolution test is an asset.
- Working knowledge of GC is an asset.
- Good written and verbal English communication skills.
- Experience
- BSc with 5 years or MSc with 3-4 years experience in a pharmaceutical lab in an RD environment.
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