Senior Specialist QMS Systems
Abbott
Date: 3 weeks ago
City: Karachi
Contract type: Full time
Position: Senior Specialist QMS Systems
Reporting to: QMS Manager
Division: Established Pharmaceutical Division - Operation
Location: Karachi -Pakistan
Job Summary
The Senior Specialist – QMS Systems is responsible for supporting the QMS Manager in planning, organizing, and executing all Quality Management System (QMS) activities at the Landhi Plant. This role ensures the timely availability and compliance of technical documents, effective implementation of Continuous Improvement Projects (CIP), adherence to cGMP. The position plays a critical role in maintaining documentation integrity, regulatory compliance, and is responsible for implementing, maintaining the effectiveness and compliance of the quality systems.
In addition to current responsibilities, the incumbent is being groomed as the potential successor to the QMS Manager, and is expected to demonstrate leadership, strategic insight, and cross-functional collaboration to take on higher responsibilities in the future.
Major Responsibilities
Reporting to: QMS Manager
Division: Established Pharmaceutical Division - Operation
Location: Karachi -Pakistan
Job Summary
The Senior Specialist – QMS Systems is responsible for supporting the QMS Manager in planning, organizing, and executing all Quality Management System (QMS) activities at the Landhi Plant. This role ensures the timely availability and compliance of technical documents, effective implementation of Continuous Improvement Projects (CIP), adherence to cGMP. The position plays a critical role in maintaining documentation integrity, regulatory compliance, and is responsible for implementing, maintaining the effectiveness and compliance of the quality systems.
In addition to current responsibilities, the incumbent is being groomed as the potential successor to the QMS Manager, and is expected to demonstrate leadership, strategic insight, and cross-functional collaboration to take on higher responsibilities in the future.
Major Responsibilities
- Assist the QMS Manager in driving all QMS-related initiatives and compliance activities across the Landhi site
- Support the drafting, implementation, and improvement of procedures within the QMS Section
- Coordinate with departmental SOP Coordinators and QA/QC staff to draft, revise, and review SOPs in alignment with Abbott policies and regulatory guidelines
- Review SOPs from multiple departments to ensure alignment with internal and external regulatory expectations and support in maintaining and updating the Site Quality Manual and Site Master File
- Monitor the issuance, distribution, and control of technical documents as per defined procedures
- Collaborate with cross-functional teams to manage workloads, prioritize activities, and escalate issues where necessary to the QMS Manager
- Actively support production and MS&T functions by reviewing technical documents, directions, and product specifications.
- Prepare and submit technical registration/re-registration packages for affiliates and importing countries
- Provide specifications and testing methods to Drug Testing Laboratories, as required
- Ensure compliance with Quality Risk Management (QRM) procedures, including execution of QRA activities and timely completions of Regional, Divisional and Global Tasks at Site
- Organize training and capability-building initiatives for the QMS Team to drive continuous improvement.
- Science Graduate/Master; preferably Chemist/Pharm D
- Minimum 4-5 years’ experience in effective handling of the QMS systems
- Strong understanding of QMS elements, cGMP, GLP, and regulatory frameworks
- Sound judgment and problem-solving using data-driven insights
- Accuracy in documentation and process reviews
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