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 positive 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.

📌 Deputy Manager - Quality Assurance (Mumbai)
🏢 Galderma
📍 Mumbai