Manager I&D QA

Abbott Laboratories; Mumbai; On-site; INR 1,800,000 - 3,000,000; Full time

Job summary

Abbott Laboratories in Mumbai invites a Manager I&D QA to lead quality support for drug product development, ensuring SOPs are prepared, reviewed and approved, and that CAPA, audits and documentation compliance are managed effectively.

The role requires extensive QA experience in pharma with a focus on process adherence and metrics reporting. You will drive internal audits and external audit readiness, while guiding QA personnel training and policy implementation.

Qualifications

• Experience of around 9 years in QA for drug product development.

Responsibilities

• Ensure quality support for all project and process related activities with EPD drug product development.
• Prepare, review and approve Standard Operating Procedures (SOPs).
• Review and approve change control, exceptions, OOS, and planned deviations.
• Manage training activities related to QA personnel.
• Manage Quality Management Review Program.
• Manage Internal Audit program and ensure compliance.
• Manage Documentation Compliance.
• Collate data and update quality metrics and monthly reports.
• Review CAPA and track its implementation within the time frame.
• Ensure implementation AQ/EQD/EID policies at site.
• Manage external and AQR audit compliance and action plans.
• Perform other activities as instructed by supervisors as required.

Job description

Roles and Responsibility- Manager I&D QA

• Responsible for ensuring quality support for all project and process related activities with EPD drug product development
• Experience -- 9 yrs
• Ensure implementation and adherence to applicable policies and procedures
• To prepare, review and approve Standard Operating procedures (SOPs)
• To review and approve change control, Exceptions, Out of specifications (OOS), planned deviations.
• To manage training activities related to QA personnel.
• To manage Quality management Review Program.
• To manage Internal Audit program and ensure compliance.
• To manage Documentation Compliance
• To collate data and update quality metrics and monthly reports.
• To review CAPA and track its Implementation within the time frame
• To ensure implementation AQ/ EQD/EID policies at site.
• To manage external and /AQR audit compliance and action plans
• Any other activities / support as instructed by the supervisors as and when required.