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Galderma
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QA Specialist

QA Specialist

Galderma

4 - 6 years

6 - 8 Lacs

Mumbai

Posted:4 days ago| Platform:

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Skills Required

Manager Internal Audit Manager Quality Assurance Dermatology EDMS Pharmacy Quality systems Packaging Healthcare Cosmetics GMP

Work Mode

Work from Office

Job Type

Full Time

Job Description

Requirement

Education/Training:

Bachelor s degree in pharmacy.

Work Experience:

Minimum six years experience in the pharma industry, acquired in Quality Assurance departments.
Experience in pharmaceuticals, cosmetics and medical device
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:

awareness of the local regulatory Guidelines and Corporate Standards and applicable laws,
Expert in presentation preparation & delivery
Analytical skills
Good, positive and proactive communication skills, English.
commitment to continued improvement in department processes and performance.

Duties

and

Responsibilities

Main Responsibilities

Designated as Responsible Person (RP) for ensuring Good Distribution Practice (GDP) in complied with for products imported and wholesaled by Affiliate.
GMP responsible person for the Affiliate as 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 end to end management of customer complaints, lias with customer care teram, internal stake holders , 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.

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