Head of QA

JOB DESCRIPTION: Job Title: Head of Quality Assurance Department: Quality Assurance Reports to: Director QAD Location: Abbott Landhi Plant, Pakistan Principal Duties : Ensure following activities of QA section: Timely availability of products Introduction of new products Implementation of CIP, QIP Quality, cGMP, GLP and Data Integrity are compliant. Ensure that Corporate, Divisional, Regional and Site internal audits are executed successfully and support in CAPA preparation To play a role of CAPA Coordinator in timely raising of deviations / CAPA related to Quality issue and its problem resolution and corrective / preventive action identification, implementation, and tracking / trending and timely closure of deviations / CAPA. Also publish deviations status as per defined frequency, ensure these are completed / approved, and all complaints are closed preferably within 30 days period. Ensure GMP compliance at floor level by conducting regular GEMBAs and maintaining the site in inspection ready state Ensure that finished product releases are finalized within agreed upon lead time and any non- compliances are resolved appropriately. Provide support to all related group leaders in planning / organizing / leading and controlling activities in their respective areas and to take action as needed. For effective use and control of activities in the area, should review daily planning in view of complying the manufacturing plan and other volume / non-volume activities in QA section and ensure compliance of planning. Review of SOPs for Quality Systems 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. Prepare weekly highlights for onward submission to region. To play role of EHS coordinator of QA department, perform the activity to meet EHS standard and local law and represent QA department during EHS Audit/ Inspection. Assuring compliance of Corporate and Divisional Policies and procedures in QA, Manufacturing, Material Management, Engineering, Human Resource / Administration. Monitor implementation of GMP/ Drug Law requirements and coordinate regulatory visits and liaise with Director QA for corrective action plan and implementation. Review and Approval of Market complaints and ensure quarterly trend reports are published. To publish KPI related to QA function and raise the RCA if not meeting the KPI target. Publish Quality metrics and other reports (QMR, QPR and other Service Reports) as per required timelines. Ensure Quality trend report is published on Quarterly basis mentioning all Quality parameters. Prepare schedule, issue agenda, and action plan and conduct Management Review Meetings Assist in preparation of QA budget / cost saving initiatives and headcount calculations. Attend various meetings to represent QA in achieving the objectives in a compliant manner. Periodic Performance review and goals with all group leaders for current year, against agreed upon goals and yearly review for all staff members for the purpose of annual appraisal. Also discuss and set goals and growth plans for staff for next years as per departmental / company strategies. Sensitive/ confidential data handled : Regulatory correspondence Audit Reports Various other confidential reports Key Areas of Accountability : ER/ CAPA, QA Inspection, QA Sampling, QA Systems, complaints Knowledge & Experience : Knowledge of documentation, validation, stability, technical problems resolution, In process controls, inspections, auditing, documentation and all other activities taking place in QC/QA and site. 10-15 years of experience in relevant field. Competencies required : Good Computer Skills Good Communication and interpersonal skills Negotiation skills Leadership skills Build Organization and inspire people Technical and analytical skills Minimum Qualifications : B Pharm / Pharm D /M.Sc 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: Yes, 10 % of the Time MEDICAL SURVEILLANCE: Not Applicable SIGNIFICANT WORK ACTIVITIES: Continuous walking for prolonged periods (more than 2 hours at a time in an 8 hour day)#J-18808-Ljbffr