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sun pharma industries
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DGM/Sr. Manager

DGM/Sr. Manager

sun pharma industries

10 - 15 years

20 - 25 Lacs

Gurugram

Posted:22 hours ago| Platform:

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Skills Required

QA Interpersonal skills Project management CMC Process development Issue resolution Biochemistry Troubleshooting quality operations Auditing

Work Mode

Work from Office

Job Type

Full Time

Job Description

Provide technical and scientific leadership to support upstream processes for early-stage development to ensure seamless handover to commercialization and life-cycle management of Sun s Branded Portfolio products manufactured internally and by a third-party suppliers/vendors.

Contribute quality input into CMC strategy and execution to ensure robust supply and advance the company s portfolio.

Represent and perform quality oversight duties in process development, characterization, scale-up, validation, tech transfer. Representation at Project Team and CMC meetings to plan for Clinical trial materials and collaborate with teams for handover to Commercial QA and manufacturing

Provide scientific leadership in functional area to support process, product investigations (including excursions) and troubleshooting.

Provide technical expertise and leadership to identify opportunities, oversee experimental planning and design, and analyze / trend, interpret, and document development results and review manufacturing data.

Authoring and review of CMC documentation for regulatory filings. Responsible to support health agency and QP queries and inspections.

Be an active engaged team member of the Development Quality team, support Management Review, represent Development QA in functional area meetings, as appropriate.

Other tasks and audits to be performed as assigned by Management.

Qualifications / Educational Requirements

MS or PhD in chemical/biochemical engineering, biochemistry, or related area with 10+ years of relevant experience.

Skills / Experience Requirements

Proven record of quality - technical manufacturing experience; ability to influence and drive technical quality rigor; capability for strategic analysis and issue resolution
Proven ability to work in a fast-paced environment with demonstrated capacity to manage multiple projects, tasks, timelines and demands
Experience risk-based approaches in decision-making related to development, characterization, and manufacturing of drug products, devices and/or biologics.
Demonstrate a collaborative teamwork and strong interpersonal skills
Demonstrated ability to communicate appropriately and effectively
Demonstrated organizational and project management skills working in a matrix environment.
Experience performing audits in global regions is a preferred. VISA to travel to US and/or EU countries is a plus.

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DGM/Sr. Manager