Assistant Manager I&D QA

Thornton Tomasetti; Mumbai; On-site; INR 1,800,000 - 3,200,000; Full time

Job summary

Abbott Laboratories in Mumbai is seeking an Assistant Manager I&D QA to ensure quality support for project and process activities within EPD drug product development. The role requires about 9 years of experience and focuses on SOPs, CAPA, audits and QA metrics to strengthen compliance and product quality.

The position involves leading QA training, managing audits, maintaining documentation, and ensuring policy adherence across site operations.

Qualifications

• Experience in QA for drug product development or manufacturing.
• Knowledge of SOPs, change control and OOS handling.
• Hands-on experience with CAPA and QC metrics.

Responsibilities

• Ensure implementation and adherence to applicable policies and procedures.
• 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 AQ/EQD/EID policies at site.
• Manage external and /AQR audit compliance and action plans.
• Support as instructed by supervisors as required.

Skills

Quality Assurance

SOP Review

Change Control

CAPA

Internal Audit

Documentation Compliance

Quality Metrics

Training Management

GxP Compliance

Job description

JOB DESCRIPTION: Roles and Responsibility- Assistant 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.

The base pay for this position is N/A

In specific locations, the pay range may vary from the range posted.

JOB FAMILY: Operations

DIVISION: EPD

Established Pharma

LOCATION: India > Mumbai : BKC Building

ADDITIONAL LOCATIONS:

WORK SHIFT: Standard

TRAVEL: Not specified

MEDICAL SURVEILLANCE: Not Applicable

SIGNIFICANT WORK ACTIVITIES: Not Applicable

Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next‑generation diagnostics, life‑changing devices, science‑based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.

The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well‑being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges.

We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings.

An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.

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