JOB DESCRIPTION:
Position: QA Compliance Officer
Reporting to: Senior Manager Compliance
Division: Established Pharmaceutical Division - Operation
Location: Karachi - Landhi Plant
Job Summary:
The QA Compliance Officer is responsible for supporting Quality Assurance and compliance activities to ensure adherence to cGMP requirements, corporate quality standards, regulatory expectations, and Quality Management System (QMS) requirements. The role involves managing supplier qualification and performance programs, supporting change control processes, ensuring audit and inspection readiness, and driving continuous quality improvement initiatives.
Major Responsibilities:
- Support and facilitate inspection readiness activities for regulatory inspections, customer audits, internal audits, and quality assessments
- Assist in the initiation, review, implementation, tracking, and closure of Change Controls, ensuring compliance with applicable quality and regulatory requirements
- Participate in the qualification, approval, induction, and periodic re-evaluation of suppliers, vendors, contractors, and service providers
- Coordinate supplier audits, vendor assessments, and qualification activities for APIs, raw materials, packaging materials, and outsourced service providers
- Develop, maintain, and periodically review the Approved Supplier List (ASL), ensuring supplier qualification records remain accurate, current, and compliant
- Monitor supplier performance using established quality metrics and KPIs and prepare performance trend reports for management review
- Coordinate cross-functional evaluations of suppliers and service providers while maintaining requalification schedules and supporting documentation
- Track and verify the timely implementation and effectiveness of CAPAs resulting from Internal Audits, Supplier Audits, Regulatory Inspections, and Regional/Corporate Audits
- Review suppliers change notifications and perform impact assessments to evaluate potential effects on product quality, regulatory compliance, and supply continuity
- Review, update, and maintain SOPs and quality procedures in response to regulatory, operational, or process changes, ensuring ongoing procedural compliance
- Provide quality and technical support for continuous improvement projects and supplier quality enhancement initiatives
- Support Product Quality Reviews (PQRs) by compiling and analyzing supplier quality data, metrics, and supporting documentation
- Prepare, review, and maintain First Lot Quality Review (FLQR) documentation associated with API and material qualification activities
- Maintain supplier qualification dossiers, audit reports, evaluation records, quality agreements, and other controlled quality documents in accordance with established procedures
- Ensure compliance with current Good Manufacturing Practices (cGMP), regulatory requirements, corporate quality standards, and Quality Management System expectations
- Perform additional quality and compliance-related duties as assigned by management to support the effectiveness and continuous improvement of the Quality Management System
Education/Knowledge & Experience:
- Science Graduate/Master; preferably Chemist/Pharm D
- 1-2 years of relevant experience in Quality Assurance, Quality Management Systems (QMS), Change Management, Supplier Quality Management
- Knowledge of cGMP requirements, pharmaceutical quality systems, and regulatory expectations
- Strong analytical, organizational, and problem-solving skills
- Effective communication and cross-functional collaboration abilities
- Proficiency in Microsoft Office applications and quality management documentation systems
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:
Pakistan > Karachi : Opp: Radio Pakistan Transmission, Hyderabad Road, Landhi
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
No
MEDICAL SURVEILLANCE:
No
SIGNIFICANT WORK ACTIVITIES:
Not Applicable
