Manager - Quality Analytical Support

Apotex; Bengaluru; On-site; INR 1,500,000 - 2,100,000; Full time

Job summary

Apotex in Bengaluru, India, seeks an experienced QA-Analytical reviewer to oversee data review, QC investigations, and approvals of lab events and COAs. The role requires coordinating cross-functional analytical activities and ensuring compliance with SOPs, LIMS specifications, and regulatory standards.

The incumbent will lead protocol approvals, manage stability studies, and approve method validations, deviations, and certificates.

Qualifications

• Educational qualification as stated: M.Sc. or M. Pharma.
• Experience in protocol and report preparation, and monitoring of process validation.
• Exposure to laboratory events review and QA processes.

Responsibilities

• Monitor Analytical data review performed by the review team.
• Oversee investigations by QC investigation team.
• Review and approve lab events, LIRs, OOTs, deviations, and anomaly investigations.
• Coordinate with cross-functional departments for analytical activities.
• Review deviations in TrackWise and approval of COAs.
• Review and approve specifications in LIMS and SOP/STP approvals.
• Monitor stability studies and approve shelf life certificates & protocols.
• Approve analytics method validations, verifications, transfers and risk assessments.
• Approve certificates of analysis for reference and impurity standards.
• Prepare/approve SOPs and forms related to analytical activities.
• Perform change control impact assessments and approvals in TrackWise.
• Conduct unannounced realtime checks and internal audits as scheduled.
• Manage Customer Request Samples activities.
• Support Business development and regulatory affairs activities.
• Batch release in SAP for raw materials and related supplies.

Skills

Analytical data review

Lab investigations

COA review & approval

Cross-functional coordination

SAP batch release

LIMS usage

Regulatory compliance

Performance coaching

Education

M.Sc./M. Pharma

Tools

LIMS

SAP

Job description

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 employees 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.