Apotex Pharmaceutical Sciences Jobs – Chemistry Apply Online
Senior Executive, Analytical Development- Documentation
Date: May 20, 2024
Location: Bangalore, KA, IN, 560099
Company: Apotex
About Apotex Inc.
Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 7,200 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 75 countries globally. Through vertical integration, the Apotex group is focused on the development and sale of generic, biosimilar and specialty products. For more information visit: www.apotex.com.
Job Summary
- Responsible for reviewing of all analytical data generated in AR&D Labs in compliance with cGMP and related SOPs and preparing reports for submission to the Regulatory agencies.
- Review of laboratory data, instrument logbook and reports wherever applicable.
- Initiation of departmental CCR’s and tracking the progress to execute the proposed changes through QMS system.
- Preparation, maintenance and archival of regulatory submission documentation like SOP, protocols, reports for method development and validation.
Job Responsibilities
- Ensures all analytical tests are done according to the test method, GMP, SOP/WI and Guidelines
- Reviews all analytical data generated by AR&D labs · Understands the detailed analytical procedures and guidelines.
- Reviews the Laboratory investigations and deviations for accuracy, compliance and completeness.
- Reviews analytical data pertaining to the analytical testing of drug substance, in-process sample, drug products and excipients.
- Reviews analytical data pertaining to additional tasks required for the submission such as comparative dissolutions studies, stability studies, photostability studies, dissolution pH & Alcohol Dose Dump studies and impurity surveys.
- Reviews analytical data pertaining to validation and technology transfer of analytical testing procedures of drug substances and drug product.
- Ensures analytical methods validation is conducted according to approved validation protocol with accuracy and precision in compliance of laboratory SOP and guidelines.
- Responsible for review and report preparation of various analytical method validation parameters.
- Verifies the integrity and traceability of all data reported.
- Ensures the accuracy of calculations and that the test method and relevant SOP’s/WIs have been followed during the performance of the analytical test.
- Prepares various analytical summary reports such as comparative dissolution report, stability summary reports, photostability report, impurity surveys, PH dissolution report,
- Alcohol Dose Dump studies report and test article report for clinical studies. Ensures the above reports with accurate content are published on ERS.
- Raising Change control for various analytical activities (Method SOP and department SOPs) by QMS trackwise
- To prepare General, Operation and Calibration Standard Operating Procedures.
- Responsible for the review of calibration documents in Analytical R&D and ensures the compliance as per cGLP requirements.
Works in a safe manner collaborating as a team member to achieve all outcomes. - Performs all work in accordance with all established regulatory, compliance and safety requirements.
- Demonstrates Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
- Ensures 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.
- All other relevant duties as assigned.
Job Requirements
Education
A graduate/post graduate in analytical chemistry, organic chemistry, pharmaceutical sciences, or related field.
Knowledge, Skills and Abilities
- Sound working and theoretical knowledge of automated laboratory instrumentations.
- Knowledge on preparation and review of various documents like SOP’s, Formats,
- Protocols, Reports, analytical data, investigation and deviation reports.
- Should have well versed knowledge on regulatory guidelines and thorough knowledge on cGMP activities
- Working knowledge of LIMS is an asset.
- Knowledge of Excel, Word, other Microsoft Office Programs and laboratory software packages.
- Excellent Verbal and written English communication skills.
- Knowledge of compliance and regulatory requirement
Experience
- BSc with 5 years or MSc with 6 years or PhD with 2 years’ experience in a pharmaceutical lab in an R&D environment.
- Minimum 7 years’ experience in pharmaceutical industry in a lab environment.
Link to Apply: APPLY ONLINE HERE
