Job Description

JOB DESCRIPTION:
Main Purpose
To lead and manage the Quality Assurance Audit and Compliance function for Abbott EPD India, ensuring that all Suppliers (Mainly) third-party manufacturing sites, contract laboratories, and service providers comply with regulatory standards and internal policies. The role involves planning and executing audits, identifying compliance risks, and driving continuous improvement across the audit function.
Main Responsibilities Audit Planning & Execution
Prepare and schedule audits for Suppliers (Mainly) with other assigned audit such as TPMs, CTLs, warehouse / Distribution centers and service providers for new and existing sites.
Conduct "For Cause" audits to investigate quality issues and significant events.
Identify and report quality and compliance risks and gaps.
Review audit responses, track CAPAs, and ensure timely audit closures.
Liaises with external vendors, contractors or suppliers to ensure that their products or services meet the organization's quality standards. Documentation & Reporting
Maintain audit records in Audit management system.
Support for preparation and publish Approved Supplier Lists (ASL).
Ensure compliance with global and local SOPs.
Support management reviews and business processes.
Qualifications & Experience:
Bachelor's/Master's degree in Pharmacy, Chemistry, or related field.
Minimum 10-15 years of experience in Quality Assurance / Quality control and diversified experience, preferably in pharmaceutical audits and compliance.
Strong knowledge of GMP, regulatory guidelines, and quality systems and able to evaluate all six system of manufacturing facility
Experience with third-party audits and supplier qualification.
Proficiency in audit documentation systems.
Excellent communication, analytical, and leadership skills.
Essential soft skills:
Strong communication and interpersonal skills.
Critical thinking and analytical ability.
Conflict resolution and stakeholder collaboration.
Ability to coach, mentor, and work cross-functionally.
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
ADDITIONAL LOCATIONS:
WORK SHIFT: Standard
TRAVEL: Not specified
MEDICAL SURVEILLANCE: Not Applicable
SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

Skills Required