Manager - Quality Analytical Support

Apotex Inc.; Bengaluru; On-site; INR 800,000 - 1,200,000; Full time

Benefits offered by this job

Accommodation for applicants with disabilities

Job summary

Apotex Inc. in Bengaluru is looking for a skilled professional to oversee analytical data reviews and ensure compliance in laboratory operations. The ideal candidate will have 10-12 years of experience, focusing on quality control and analytical processes.

This role involves monitoring investigations, reviewing lab events, and preparing detailed reports. Candidates must have an M.Sc. or M. Pharma degree and be adept at cross-functional coordination with a focus on fostering a safe and supportive work environment for all employees.

Qualifications

• 10 to 12 years of experience in relevant roles.
• Demonstrated skills in preparation of protocols and reports.
• Experience monitoring process validation.

Responsibilities

• Monitor analytical data review performed by review team.
• Approve lab events, deviations, and specifications.
• Ensure compliance with EHS policies during routine activities.
• Lead employee performance conversations and development.

Skills

Analytical data review

Quality Control (QC) investigations

Cross-functional coordination

Document approval (SOPs, COAs)

Change control impact assessments

Education

M.Sc./M. Pharma

Tools

SAP

Job description

About Apotex Inc. Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions. For more information visit: www.apotex.com.

Job Summary

Responsible for ensuring the Analytical data review Review & Approval of Lab events OOS, OOT.

Job Responsibilities

• Responsible to monitor the Analytical data review performed by review team.
• Responsible to monitor the investigations performed by QC investigation team.
• Review & Approval of Lab events, Out of specification results (LIRs), Out of trend (OOTs), Deviations, Anomalous results Investigation reports.
• Coordination with cross functional departments for smooth functioning of analytical activities.
• Review and approval of deviations in Track wise.
• Review and approval of Certificate of analysis (COAs).
• Review and approval of Specifications in LIMS and approvals of SOPs and STPs.
• Monitoring of stability studies activities, Review and approval of shelf life certificates & Protocols.
• Approval of protocols & reports of analytical method validations, verifications, Transfers and risk assessment reports.
• Approval of certificate of analysis of reference standards & Impurity standards.
• Preparation/Approval of SOPs and forms related to analytical activities.
• To perform Change control impact assessments and approvals in Trask wise.
• To perform un‑announced Realtime checks and Internal audits as per the Schedule.
• Managing of Customer Request Samples activities.
• Coordination and providing the support for Business development and regulatory affairs activities.
• Batch release in SAP for Raw material, Solvents, Operational supplies (Packaging Materials, Filter bags etc.).
• Participate and lead performance conversations with employees, including monthly one on ones, to connect on performance; check in on employee's progress toward achieving Objectives, offer support and remove barriers; and, communicate and revisit performance expectations to reinforce and encourage high performance culture and a safe working environment for all employees.
• Utilize open, honest, two way communication to build trust‑based relationships with employees, business partners .and direct leader while continuously improving leadership capabilities by personally seeking feedback and development.
• Create a culture which values trust and provides the opportunity for Employee development and growth in pursuit of our purpose and demonstrating our core Values - Collaboration, Courage, Perseverance and Passion.
• Utilize your networks to attract and hire talent in a comprehensive, differentiated and consistent manner essential to our continued growth; then, onboard new employees by providing a consistent experience that reflects the values and commitments made to candidates during the hiring process.
• Ensure adherence of team members (direct reports) with all compliance programs and company policies and procedures.
• To adhere the EHS policy and procedure in routine activities.
• To involving EHS related activities on need basis.
• All other duties as assigned.

Job Requirements

• Education
  • M.Sc./ M. Pharma
• Experience
  • 10 to 12 year experience, with demonstrated skill in preparation of protocol and reports, monitoring of process validation, etc.

At Apotex, we are committed to fostering a welcoming and accessible work environment, where everyone feels valued, respected, and supported to succeed.

We offer 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.