Job Summary
of analytical method optimization /development validation/ verification of analytical test methods related to Compendia Inhouse developed methods Site transfer methods Regulatory queries Method Life Cycle Management (MLCM) studies Supplier Driven Changes( SDC) and other procedural updations.Preparation of method validation/verification protocols and reports.
Job Responsibilities
- of Method optimization / development studies. Method validation/ verification of Inhouse methods Compendia SDC MLCM and Cleaning Analytical methods by adhering to the regulatory procedures.
- Preparation of Method verification/ Method transfer Protocols and reports.
- of Method transfer analysis and reporting.
- of analytical studies related to Regulatory queries/submisiion requirement.
- Perform all work in accordance with all established regulatory compliance and safety requirements.
- Responsible for the activities in the Quality Control Laboratory including cGLP documentation and implementation of departmental quality system.
- 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 and Environment policies and HR policies.
- All other relevant duties as assigned.
Job Requirements
Education
- MinimumMSc/BPharm or any equivalent degree.
- Knowledge Skills And Abilities
- Command on MicrosoftOffice (Word Excel).
- Knowledge in Method optimization/development activities.
- Best in effective completion of work activities to meet the time lines.
- Able to perform multi parameter analysis on HPLC instrument.
Experience
Minimum 3 to 6 years of experience in GMP regulated Pharmaceutical Industry.
At Apotex we are committed to fostering an inclusive accessible work environment where all employees feel valued respected and supported.
Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing please advise us if you require an accommodation.
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Remote Work :
No