Deputy Manager - Quality Assurance

Galderma; Mumbai; On-site; INR 1,200,000 - 2,000,000; Full time

Job summary

Galderma in Mumbai, India is seeking a Quality Assurance professional to manage QA activities and maintain the local QMS, ensuring compliance across GDP standards and regulatory guidelines.

The role covers handling customer complaints, management of imported shipments, and CAPA-driven quality improvements. Proficiency with TrackWise, PATH, eDMS, Excel, PowerPoint, and strong communication skills are essential for success in this position.

Qualifications

• Bachelor’s degree in pharmacy.
• 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

Responsibilities

• Designated as back up Responsible Person (RP) for GDP compliance for products imported and wholesaled.
• Back up GMP responsible person for the Affiliate when applicable.
• Handling of customer complaints, processing the case in Trackwise and ensuring compliance with SOPs.
• Perform quality and compliance tasks including processing product complaints and recall coordination.
• Participate in creation/update of local SOPs to reflect local practices with Corporate Policies and SOPs.
• Implementing and maintaining the QMS to ensure required processes are established and effective.
• Support quality systems processes such as internal audits, change control, management reviews, vendor management, deviation management and CAPA.
• Compile and update training manuals and undertake induction training related to QMS.
• Maintenance, analysis and reporting of Quality KPIs.
• Review packaging artworks from regulatory perspective as per SOPs.
• Managing imported shipments, review data loggers, and redressing artworks.
• Ensure proper system utilization for eDMS / PATH / Trackwise, admin for mentioned software.
• Support cross functional review/approval of GMP documents.
• Execute assigned tasks by line manager timely.
• Process owner of quality systems including internal audits, change control, management reviews, deviation management and CAPA.
• Recall and mock recall management.
• Drive quality improvement projects and quality day at India affiliate.

Skills

English fluency

Analytical skills

Communication skills

Team player

Process improvement

Excel / MS Word / PowerPoint

TrackWise

PATH / eDMS familiarity

Education

Bachelor’s degree in pharmacy

Tools

TrackWise

PATH

eDMS

Excel

PowerPoint

MS Word

Job description

• 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.

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.
• 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.