Assistant Manager I&D QA

Abbott; Mumbai City; On-site; INR 1,500,000 - 2,500,000; Full time

Job summary

Abbott in Mumbai is seeking an Assistant Manager I&D QA to ensure quality support for project and process activities in the EPD drug product development program.

The role requires around 9 years of experience, with responsibilities to prepare, review and approve SOPs, change controls, CAPAs, internal audits, training, and quality metrics. It also involves documentation compliance and coordination of audits and actions at the site.

Qualifications

• Quality support for project and process activities in drug product development.

Responsibilities

• Prepare, review and approve Standard Operating Procedures (SOPs).
• Review and approve change control, exceptions, OOS, planned deviations.
• Manage training activities for QA personnel.
• Oversee Quality Management Review Program.
• Manage Internal Audit program and ensure compliance.
• Ensure Documentation Compliance.
• Collate data and update quality metrics and monthly reports.
• Review CAPA and track its implementation.
• Ensure AQ/EQD/EID policies at site.
• Coordinate external audit compliance and action plans.

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 Quality

DIVISION:

EPD Established Pharma

LOCATION:

India > Mumbai : BKC Building

WORK SHIFT:

Standard

TRAVEL:

Not specified

MEDICAL SURVEILLANCE:

Not Applicable

SIGNIFICANT WORK ACTIVITIES:

Not Applicable