Quality Systems Manager

JOB DESCRIPTION:

Job Title:       Quality Systems Manager

Department:  Quality Assurance 

Reports to:     Director QAD

Location:       Abbott Landhi Plant Pakistan 

Job Summary:

Establish and maintain the Quality System for the site, ensuring that Standard Operating Procedures are in place and compliance with cGMP is maintained. Monitor and evaluate the level of cGMP compliance for products manufactured, packed, tested, and released through Key Performance Indicators (KPIs). Continuously improve and harmonize the Site Quality Systems, strengthen quality awareness, support operations, technical services, process improvements, and product quality review.

Principal Duties:

• Monitor issuance and distribution of all SOPs & technical documents at point of use as per procedure (KAR-QA-008-01-SOP).
• Update BOM in BPCS System.
• Provide active support to production system in reviewing of Directions. 
• Review of checklist after raw materials, packaging materials & finished product specification update on STARLIMs.
• Prepare & submit technical registration / re-registration packages for affiliate and other importing countries.
• Ensure & provide testing methods, specification (as required) to Drug Testing Laboratories.
• For effective use and control of activities in Doc. cell, should write procedures. Improve upon/ update as required, implement, maintain documentation as required by the procedure and assure compliance.
• Provide active support to MS&T by reviewing and providing technical documents for new products, product improvement and CI projects to achieve affiliate targets.
• Support to affiliate project teams to provide validation documents as and when requested.
• For continuous improvement of skills of staff, arrange training & orientation of members in Documentation cell.
• Support Compendia project team by reviewing and approving EPD change requests.
• Implement Quality risk management at Landhi plant and ensure compliance of QRA activities as per Standard Procedures (KAR-QA-328-01-SOP).
• Implement ICH Q3D elemental impurities assessment at site.
• Manages requisition and timely release of Raw material, finished products and packing material.
• Ensure the site has implemented robust Quality Systems in compliance with the Quality Management System and relevant regulatory and legislative requirements.
• Ensure the incorporation of Abbott’s QMS requirements and applicable local quality standards (e.g., GMP, ICH, ISO) and regulations into site policies, procedures, and processes. Manage timely and efficient document review/revision processes to ensure compliance with current standards.
• Actively manage the local Quality Systems team, setting development and objective targets.
• Lead the creation and maintenance of the Site Improvement Plan for continuous improvement.
• Serve as a permanent member of the Site Change Control Committee.
• Lead the implementation and management of the site document management system.
• Oversee the APQR process and management at the site.
• Utilize active thinking to generate creative solutions to complex technical problems.
• Proactively manage interactions and commitments related to Regulatory inspections, AQR Audit findings, and site readiness.
• Establish key performance indicators (KPIs) for site Quality System operations. Develop efficient data gathering mechanisms, assess performance data, and implement actions to improve performance levels.
• Use the performance review and talent management processes to maintain a high-performance, energized work team. Construct succession plans for key positions.
• Utilize active thinking to generate creative solutions to complex technical problems.
• Ensure compliance with GMP (Good Manufacturing Practices), Quality, and other related policies, guidelines, and requirements as applicable by law and Abbott’s Corporate Guidelines.
• Ensure compliance with Environment, Health, and Safety policies, guidelines, and requirements as applicable by law and Abbott Corporate Guidelines.
• Perform any other responsibilities assigned from time to time as per business requirements.

Knowledge & Experience:

•  5 years of relevant experience.

Competencies required:

• Good computer skills
• Good Communication and interpersonal skills

Minimum Qualifications:

Science Graduate, preferably Master's in Science or Bachelor's or Doctor of Pharmacy.

The base pay for this position is

N/A

In specific locations, the pay range may vary from the range posted.

JOB FAMILY:Operations QualityDIVISION:EPD Established PharmaLOCATION:Pakistan > Karachi : Opp: Radio Pakistan Transmission, Hyderabad Road, LandhiADDITIONAL LOCATIONS:WORK SHIFT:StandardTRAVEL:NoMEDICAL SURVEILLANCE:Not ApplicableSIGNIFICANT WORK ACTIVITIES:Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)