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Abbott

Assistant Manager I&D QA

Abbott Mumbai City, Maharashtra, India

Hospitals and Health Care · 10,001+ employees

19 h ago
qa Senior (5-10 yrs) Full-time India
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About the role

The Assistant Manager is responsible for ensuring quality support for drug product development activities and maintaining adherence to policies and procedures. Key duties include managing internal audits, reviewing CAPA, overseeing documentation compliance, and managing quality management review programs.

What they look for

Quality Assurance Standard Operating Procedures Change Control CAPA Internal Audit Documentation Compliance Quality Metrics Drug Product Development Regulatory Compliance Training Management Quality Management Review

Requirements

The candidate must have 9 years of experience in quality assurance within the pharmaceutical industry. Proficiency in managing SOPs, change controls, and audit compliance is required.

Full 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/AIn specific locations, the pay range may vary from the range posted.

     

JOB FAMILY:

Operations Quality

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

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