Senior Manager - Quality Validation & Engineering

Apotex Inc.; Bengaluru; On-site; INR 2,500,000 - 4,200,000; Full time

Job summary

Apotex Inc. in Bengaluru seeks a senior professional to manage qualification and validation activities across equipment, utilities, processes, cleaning and packaging, ensuring compliance with regulatory standards.

The role requires 12-15 years in GMP pharma, strong leadership, collaboration with cross-functional teams, and a focus on quality and continuous improvement.

Qualifications

• Knowledge of qualification and validation of Equipment, Facility, Utilities, Process and Cleaning.
• Strong interpersonal and communication skills.
• Ability to drive validation projects effectively.

Responsibilities

• Review and approve documents related to equipment/utility qualification, cleaning validation, process validation, hold time studies and packaging validation.
• Approve layouts, yearly and monthly schedules, and planners.
• Act as SME for Qualifications and Validations during Regulatory audits and ensure regulatory compliance.
• Assess change controls for facility, equipment, process, utility, cleaning and packaging.
• Review and approve standard operating procedures.
• Coordinate and implement training activities for team members.
• Review site Validation Master Plan and related documents.
• Review and approve process validation and cleaning validation protocols and reports.
• Coordinate with cross-functional teams on investigations.
• Uphold corporate values and ensure regulatory and safety compliance.

Skills

Qualification and Validation

Interpersonal communication

Engineering project leadership

Education

Bachelor of Pharmacy/Science or equivalent

Job description

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 6000 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 70 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

To manage the entire qualification and validation activities in the site specifically related to equipment/utility qualification, cleaning validation, process validation, packaging validation and perform the activities in compliance with the various regulatory guidelines and standards. To monitor regular activities related to quality validation and engineering as per established procedures.

Job Responsibilities

• Review and approval of documents pertaining to equipment/utility qualification, cleaning validation, process validation, hold time studies and packaging validation.
• Approval of layouts, yearly & monthly schedules, to be added planners.
• SME for Qualifications and Validations during Regulatory audits and ensuring compliance to regulatory requirements.
• Assess change controls related facility, equipment, process, utility, cleaning and packaging.
• Review & approve of standard operating procedures.
• Co-ordination and implementation of training activities of team members.
• Responsible for review of site VMP’s (Validation Master Plan) and related documents.
• Responsible for review and approval of process validation & cleaning validation protocols and reports.
• Co-ordinate with cross functional teams in Investigations carried out at ARPL.
• Performs all work in support of our Corporate Values of Collaboration, Courage, Perseverance and Passion, Demonstrates strong and visible support of our values.
• Performs all work in accordance with all established regulatory and compliance and safety requirements.
• All other duties as assigned as per the expertise in the relevant subject.

Job Requirements

• Education
  • Minimum Bachelor of Pharmacy/ Science or any equivalent degree.
• Knowledge, Skills and Abilities
  • Possess sound knowledge in Qualification and Validation of Equipment, Facility, Utilities, Process and Cleaning
  • Maintains good Interpersonal skills and communication skills.
  • Strives to drive projects related to Validations & Engineering effectively.
• Experience
  • Minimum 12 - 15 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.