Junior Manager-APIPL-AAR AP

Job Summary

• To ensure analytical and research activities with current regulatory needs.
• To build analytical capacity within the department, to ensure compliance and adherence to the standard operating procedure. Support to the cross functional department to enhance collaboration and business needs.
• To ensure and adhere to Apotex quality values in order to make quality pharmaceuticals.

Job Responsibilities

• Validation of analytical methods for drug substance, intermediates and raw materials.
• Preparation of validation protocol for drug substance, intermediates and raw materials.
• Preparation of validation summary report for validated analytical methods and online documentation of analysis in laboratory notebook
• Cleaning method development and validation by HPLC & UV (Rinse and Swab method).
• Additional Test request analysis.
• Analytical support for the routine anlysis of impurities, raw materials, intermedietes and drug substances.
• Anatical support for the Standard certification of impurities,raw materials,intermediates and drug substance.
• Performing protocol based method transfer activities of analytical methods for drug substance, intermediates and raw materials.
• Preparation of Internal Method Transfer protocol for drug substance, intermediates and raw materials.
• Preparation/Review of SOPs relevant to AD department.
• Preparation/Review of method of analysis.
• Initiation of Change control through Trackwise related to AD.
• Upkeep of Laboratory cleanliness, safety and Good Laboratory Practices (GLP).
• To adhere the EHS policy & procedure in routine activities.
• 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.

Job Requirements

Education

• Minimum Master’s degree in science / pharmacy.

Knowledge, Skills and Abilities

• Handling of Empower software
• Handling of Tiamo 2.5 multi software
• Handling of Spectrum1 Software
• Handling of Chemstation software
• Handling of Trackwise
• Highly Responsible, organized, self-motivated with excellent analytical aptitude, Good Communication, project management skills and Personality development virtues.

Experience

• 6 + years of experience in Analytical Research & development.