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Lupin
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Deputy General Manager - PDL

Deputy General Manager - PDL

Lupin

15 - 20 years

50 - 60 Lacs

Nagpur

Posted:1 day ago| Platform:

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Skills Required

Supervisor SAP Pharma Pharmacy Manager Technology Process excellence Process development Inspection Stakeholder management Regulatory affairs

Work Mode

Work from Office

Job Type

Full Time

Job Description

To coordinate with research and Development / Plant for technology transfer execution of exhibit batches, launch products and validation batches.

To coordinate with purchase department for availability of all raw materials to ensure smooth execution of trial bathes, scale up batches, Exhibit batches & Pre-validation batches.

Design and approval of documents related to manufacturing of scale up batches, exhibit batches, validation batches and commercial batches and support to execution.

To conduct the process validation of the product.

To support site-regulatory affairs in timely filing of exhibit products/ Variation batches.

To assist plant in regulatory inspection of customers and regulatory agencies.

To conduct technology transfer of products from other locations to Nagpur plant and vice versa.

Carrying out self-inspection and review of self-inspection reports.

Complete self-training and monitor training of team members on the relevant SOP s.

To perform the OOS/OOE investigation for the batch failure and to find out the root cause. Implementation of CAPA to prevent recurrence of failure.

Supervise compliance to all cGMP or any other regulatory requirements, including EH&S requirements.

Report any quality concerns or suggestions for improvements to product and process to superior.

Execute and supervise all tasks and activities as per the applicable SOP s.

Handling of QAMS and SAP systems as per requirement and given role.

Review and approval of document pertaining to PDL and support to PDL related activities.

Preparation and review of functional procedures (SOP s) and related documentation activities for Corporate Technology Transfer Function.

Work Experience

Candidate must be M Pharma with total experience of 15 to 20 years in Process Development / Technology Transfer /MS&T

Education

Graduation in Pharmacy

Masters in Pharmacy

Competencies

Customer Centricity

Developing Talent

Collaboration

Strategic Agility

Process Excellence

Stakeholder Management

Innovation & Creativity

Result Orientation

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Deputy General Manager - PDL