Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries.
Post : Head – Quality Assurance
• Ensure 24 X 7 compliance of Oral Dosage Facility.
• Track and monitor Quality Management System at Oral Dosage Facility.
• Lead and manage strategic and operational performance of the quality department, ensuring successful delivery of business strategy, Key Performance Indicators and objectives, whilst adhering to regulatory compliance and achieving commercial success.
• To ensure the quality systems are maintain in compliance with Abbott standards.
• Ensure failures/ events/ complaints are adequately investigated and to ensure action items and corrective or preventive actions are identified, addressed and successfully implemented.
• Ensure implementation of quality risk management and to proactively identifying, scientifically evaluating and controlling potential risks to people safety, product, facility, equipment and infrastructure.
• Review, assess and appraise important product quality and product safety issues and field actions and track execution.
• Decision on batch disposition and on product recall based on root cause identification.
• Review and approve compliance report following external (customer / regulatory) audit / corporate audit and ensure compliance.
• To review the QMS tracker and ensure that all critical and major QMS documents meet the requirement and up to the mark.
• Interact with innovation & Development for new products and projects with reference to development, scale-up and trials.
• Evaluate and approve major change controls, support investigation and approval and closure of change controls, deviations, OOSs, market complaints.
• To ensure review of batch documentation and timely release of batches for distribution.
• Suggest improvement I simplification in product presentation/ packing/ quality. Streamlining processes and removing bottlenecks.
• Responsible for working in collaboration with RA, l&D, MS&T and Business Development for identification of new products and its evaluation.
• Evaluate technology transfer from I&D and other sites. Respond to queries / notices from FDA authorities and ensure appropriate investigations wherever required.
• Setting KRA for subordinates, monitoring and mentoring the team for achieving set goals.
• Executing performance review identifying the training and development needs of staff and arranging for requisite training.
• To develop talent with appropriate skills and competency.
• To conduct self-inspection/ internal audit as per site Internal Audit Program.
• To investigate and provide CAPA for self-inspection / internal audit and external audit observation.
• Making sure that internal audits are performed. To ensure GMP related training to people at site.
• To ensure timely review, approval and closure of Annual Products Review. To identify action items of product quality issues from quality trends and product reviews.
• To notify contract giver for any kind of undesirable event which may have potential to harm product, process or people and to ensure balance between service level agreement and compliance.
• To escalate compliance risk to Head Quality.
• To ensure effective implementation of actions items derived from QRM.
• To conduct GEMBA rounds from time to time and ensure system compliance at all times.
Qualification : B.Pharma / M.Pharma / M.Sc
Location : Ahmedabad
Industry Type : Pharma / Healthcare/ Clinical research
Job ID : 31060270
End Date : 10th July, 2023
See All Other Jobs in our Database