Deputy Manager - Quality Assurance

Core Mission

• Manage activities related to Quality Assurance
• Maintain the local QMS and monitor its compliance status.
• Quality management of customer complaint.
• Quality management of imported shipment.
• Quality management of redressing activity and warehouse compliance.
• Local quality admin for eDMS / PATH, TrackWise, Power BI.
• Expertise in monthly reporting, trending, presentation, powerpoint.
• To drive continuous improvement.

Work Environment & Key Data

• Location: India / Mumbai
• Reporting: Lead Quality.

Requirement

Education/Training:

• Bachelor's degree in pharmacy.

Work Experience:

• Minimum five years experience in the pharma industry, acquired in Quality Assurance departments.
• Experience in pharmaceuticals.
• Good skill and experience for handling of customer complaints, Deviation and QMS management.
• Be familiar with GDP, ISO9001, ISO13485 requirements and internal audit.
• Well verse with Excel, MS Word & Powerpoint, Trackwise, PATH & eDMS

Required pre-requisites skills for this position:

• Able to read, write and speak English fluently.
• awareness of the local regulatory Guidelines and Corporate Standards and applicable laws.
• Analytical skills
• Good, positive and proactive communication skills.
• Commitment to continued improvement in department processes and performance.
• Stakeholder management.
• A good understanding of the commercial drivers of the life science industry and an associated ability to provide advice/guidance that takes these into consideration
• Analytical skills
• Strong team player, assisting others with workload peaks and the management of challenging situations
• Expert in cost centre management for quality department.
• Proactively contributes to a positive team attitude and highly productive work environment

Duties and Responsibilities

Main Responsibilities

• Designated as back up Responsible Person (RP) for ensuring Good Distribution Practice (GDP) is complied with for products imported and wholesaled by Affiliate.
• Back up GMP responsible person for the Affiliate when applicable
• Handling of customer complaints, processing the case in Trackwise and work / ensure compliance in accordance with respective SOP.
• Perform quality and compliance specific tasks including but not limited to processing product complaints, review of information about secondary packaging/redressing, ensure proper labelling of products at the distributor, and product recall coordination.
• Participate in the creation/update of local SOPs to reflect local practices in accordance with Corporate Policies and SOPs
• Implementing and maintaining the QMS to ensure that required processes are established and effective.
• Support in quality systems processes such as, but not limited to; internal audits/self-inspection, change control, management reviews, 3rd party vendor management, deviation management and CAPA
• Compile and update training manuals, undertake induction training and refresher training related to QMS for local affiliate staff
• Maintenance, analysis and reporting of Quality KPIs
• Ensure local repackaging of products is performed in accordance with specifications and required licenses.
• Review all packaging artworks from a local regulatory perspective as per internal / Corporate and local SOPs in place.
• Managing imported shipment, review of data loggers, and review all redressing artworks from a quality prospectives.
• Ensure proper system utilization for eDMS / PATH / Trackwise/Smartcockpit- participate as admin for mentioned software.
• To Support cross functional team in review and approval of GMP documents
• Execute assigned task by line manger on time-to-time basis.
• Process owner of quality systems such as, but not limited to; internal audits/self-inspection, change control, management reviews, deviation management and CAPA.
• Recall and mock recall management.
• To drive quality improvement projects, awareness, quality day at India affiliate.