Lead Executive - Stability Data Analytics

Apotex; Mumbai; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Apotex in Mumbai is seeking a Stability Data Analyst to summarize and review stability data, ensuring shelf lives for commercial products are supported. You will generate stability reports and support APQRs to meet GMP timelines.

The role requires strong data analysis, familiarity with cGMP, and coordination with QA and development teams. Experience with stability requirements and regulatory expectations is essential.

Qualifications

• Master's degree in Science or Pharmacy.
• Strong understanding of pharmaceutical Quality Control systems.
• Demonstrated knowledge of stability requirements.
• Excellent written and verbal communication skills.
• Experience with Microsoft Office applications; SAP, LIMS, TrackWise is an added advantage.

Responsibilities

• Prepare Stability Summary Reports within compliance time frame.
• Ensure accuracy and completeness of reports per Apotex procedures.
• Provide summaries for special projects and product evaluations requested by internal or external customers.
• Review Stability data from third party affiliates for compliance.
• Perform Stability Impact Assessment for out-of-trend results.
• Perform shelf life extensions or reductions as required and per procedures.
• Interpret statistical analysis from software and provide APQR contributions.

Skills

Quality Control

Data analysis

Stability requirements

Team player

Time management

Communication skills

MS Office

SAP/LIMS/TrackWise

Education

Master's degree in Science / Pharmacy

Tools

SAP

LIMS

TrackWise

Job description

Job Summary

• Responsible to summarize and review stability data to ensuring that Apotex commercial products shelf lives are supported.
• Responsible to perform Stability data trending for investigations and for Annual Stability Summary Review packages for the APQRs to ensure compliance with established timelines and Good Manufacturing Practices.
• Provide required stability data to customers for their product compliance files.

Job Responsibilities

• Prepare Stability Summary Reports within compliance time frame.
• To ensure summary reports are correct and complete as per Apotex procedures.
• Prepare and provide summary reports for special projects and product evaluations requested by internal or external customers.
• Review Stability data from third party affiliates for compliance.
• Perform Stability Impact Assessment for out-of-trend results obtained at release for drug product as per approved procedures.
• Perform shelf life extensions or reductions for product as required and as per approved procedures.
• Perform trend analysis as requested by the customers and as per approved procedures.
• Review and evaluate Stability data for the product to ensure that no significant trends are developing that warrants attention and that the approved shelf life continues to be justified.
• Interpret statistical analysis from NWA software.
• Provide Annual Stability Review contribution packages to QA Product Review group for the Annual Product Quality Review (APQR). Notify Team Leader of any adverse trends detected.
• Works as an effective team member to meet department goals, sharing knowledge with team members.
• Maintain compliance to all health and safety standards, Good Manufacturing Practices, Good Documentation Practices and regulatory requirements. Responsible and accountable for compliance with all aspects of the local safety regulations, as well as Apotex s Health and Safety policies, and Safe Work Procedures.
• Performs all work in support of our Corporate Values of Courage, Collaboration, Pride and Perseverance; Demonstrates strong and visible support of our values.
• To act as Department Training Coordinator (DTC) in Stability Data Analytics Team.
• 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.
• All other relevant duties as assigned.

Job Requirements

• Education
  • Master s degree in Science / Pharmacy
• Knowledge, Skills and Abilities
  • Must have Good understanding of pharmaceutical Quality Control systems.
  • Strong data analysis decision-making skills.
  • Demonstrated knowledge of Stability requirements.
  • Self-starter, good interpersonal skills and results oriented team player.
  • Strong organisational, time management skills and able to work with minimum supervision.
  • Communicate findings to the Team leader, an elevate any critical issues arising from the Stability summary report.
  • Possess the ability to manage multiple tasks and work independently in ambiguous situations.
  • Work both independently and as part on intra/inter-departmental teams to ensure that all work is completed in a timely manner to meet both business and quality standards.
  • Good understanding of cGMP regulations experience with international regulations
  • (e.g. FDA, EU) an asset.
  • Excellent written and verbal communication skills.
  • Experience with Microsoft Office applications. SAP, LIMS, TrackWise an added advantage.
• Experience
  • Minimum 4-8 years in the pharmaceutical industry with an emphasis on Quality Control Analytical data interpretation.