Senior Manager QA

JOB DESCRIPTION:

Job Summary: Provide support to Head of Quality in Korangi QA activities. To implement Quality Assurance and other strategies aimed at achieving the Quality Assurance goals and supporting the business growth in Pakistan.

Principal Duties:

• To make sure that activities of QA Section do not result in:

• Delay or non-availability of products
• Delay in introduction of new products
• Delay in implementation of CIP.
• Failure of the team.
• Compromise on Quality and cGMP.

• To ensure that Quality issues at site are handled properly and resolution plan identification, implementation and tracking / trending and timely close out of product complaints, ER/ CAPA, investigations.
• To ensure that all complaints are timely investigated and it's tracking and trending as per requirement of Abbott's procedures and timely closed within stipulated period,
• To ensure that all Quality Systems are maintained, implement and their effectiveness.
• To assure that finished product release as per requirement.
• To provide help to all related Group Leaders in planning/ organizing / leading and controlling activities in their respective areas and to discuss with Head of Quality, action taken, and help provided to Group Leaders in case of anticipated crossing lead times to bring it within the agreed upon lead time.
• Review SOPs for Quality System for effective control of all related activities, subsequent updating of these SOPs in case of change in practices and monitor compliance of all these SOPs.
• To perform the internal audit and GEMBA where required
• Review of daily planning in view of complying the Manufacturing Plan and other volume / non-volume activities in QA Section.
• To perform the activity to meet EHS standard as required and represent QA Department during EHS Audit / Inspection.
• To oversee supplier compliance / vendor approval program and review / approve the documentation as required.   
• Assuring compliance of Corporate and Divisional Policies and Procedures in Operations and QA. Monitor implementation of GMP / Drug Law's requirements and coordinate regulatory visits and liaise with Head of Quality for corrective actions plan and implementation.
• To assist Head of Quality in publishing Quality metrics for Abbott Region/ Division as per required timeline.
• To prepare schedule, agenda, conduct Site Performance Review, Management Review Meetings, issue meeting minutes and liaise with Head of Quality for Action items decided in the meetings.
• To assist Head of Quality in preparation of QA Budget / CEP Items and Head count calculations.
• Attending committees, as directed by Head of Quality and represent QA in achieving the objectives of the committee effectively.
• To arrange Preparation/Approval of Job Descriptions of all direct reports.
• To finalized and follow up for action plans defined in divisional, AQR, regulatory audits and other audits as directed.
• To support the training program and assess the training needs of direct reports and to ensure the documentation.
• To ensure that timely completion of Validation related activities and preparation of Validation Master Plan and Validation Master Schedule and its approval and implementation.
• To ensure timely completion activities related to dispensing verification, sampling, and In-process.
• To maintain and timely implementation of requirements of Drugs Act, 1976 and DRAP Act, 2012, AQ, EQD and local SOPs.
• To ensure timely responses to any corresponding related to Regulatory and DRAP as advised by Head of Quality.
• To ensure that maintenance of file samples as per requirement of regulatory and Abbott's policies.
• Supports to QA employees with regards to growth plan and goals are achieved on time.
• Any special project, assigned by Head of Quality.

Knowledge & Experience:

• Knowledge of documentation, Validation, Stability, technical problem resolution, In- Process control, inspection, auditing, documentation and other all activities taking place in QC/QA.
• Over 10 years of experience in relevant fields.

Minimum Qualifications:

• B Pharm / Pharm D /M.Sc. Chemistry/ Microbiology/ Pharmacy
• Preferably Ph.D.

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 sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)