Senior Executive, Quality Control

About Apotex Inc.

Job Summary

Job Responsibilities

• Review of Raw material/ Packing material/ Water Analysis / In-process/Semi-finished / finished product / Validation Samples/Hold time study samples / stability Samples /Analytical method validation , Technology Transfer samples , calibrations and any other samples in Quality control laboratory.
• To be responsible for all activities in the quality control Laboratory, including cGLP, documentation and implementation of departmental quality systems.
• Supporting for closing of investigations and giving training for respective investigation wherever required as per procedure.
• To provide technical review support to Apotex group of companies during activities like technology transfer by assisting Senior Executive/Assistant manager/Deputy Manager.
• To generate documents and maintain records and required trending ,training related to laboratory activities.
• Performs all work in accordance with all established regulatory, compliance and safety requirements.
• Perform all work in support of our Corporate Values and Demonstrates strong and visible support of our values.
• Perform all other duties as assigned by Head of the Department\Designee.
• Works in a safe manner , collaborating as a team member to achieve all outcomes.
• 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
• Minimum MSc/B Pharma or any equivalent degree.
• Knowledge, Skills and Abilities:
• Data base Management system like Empower, LIMS, SAP & QMS.
• Technical skill in reviewing Quality control data.
• Maintaining Good interpersonal skills and communication skills.
• Well expertised in cGDP and cGLP.

• Experience
• Minimum 5 to 9 year's experience in GMP regulated pharmaceutical industry.