About Natco Pharma
About the Job
Urgent requirement for Head #ARD (API) at Natco Pharma Ltd.
Department : AR&D & DQA (API)
Position : Vice President / Sr Vice President
Qualification : Ph. D / M. S. Pharmaceutical Sciences
Experience : 25+ years
Work Location : Natco Research Center - Hyderabad
This requirement is for Head AR&D API (VP / Sr VP) only.
Job Role
· Responsible for the management of the analytical research & development activities, and Development Quality Assurance Activities, ensuring that products have been developed according to the specifications and seeking corrections / solutions.
Responsibilities
· Responsible for development and approval of vendors, vendor audits in coordination with purchase department and CQA
· Review and approval of Quality Documents (Specifications, Test Methods, SOPs for R&D, Validation Reports and Documents related to test license procurement)
· Review and approval of Validation, Qualification protocols and reports at R&D
· Responsible for establishing the change control system, review, and an approving authority.
· Responsible for document and data control which includes storage and retrieval of documents and records.
· Responsible for the implementation of GLP and Quality systems in Coordination with related departments
· Responsible for ensuring that R&D investigations of critical deviations and plant related OOS are conducted in adherence to GLP / GMP regulations.
· Responsible for identification of training needs and imparting training to sub ordinates and personnel of related departments in co- ordination with personnel department.
· Responsible for implementation of SOPs, Specifications and test methods, protocols, and validation reports
· Planning and prioritization of Analytical Development and Validations across the projects
· Prepare annual Budgets (Capex & Revenue) for the function and seek approval: ensure budgetary controls.
· Regular interactions with IP /RA/ API Manufacturing and Formulation R&D and Manufacturing
· Responsible for approval of Working Standards and impurities at R&D and supply to manufacturing Sites.
· Provide technical support to API & FRD for solid state characterization.
· Proficiency in all analytical R&D processes such as stability studies, impurities qualification etc.
Only Interested and relevant experienced candidates can drop profiles to [email protected]
Packing development - Specialist:
Experience: 8-12 years
Job Role:
Work together with NPL group, Portfolio, CMO , Mktg , QA and supply accomplices in plan, execution and send off of new items in Exchange Gx India
Give bundling experiences to choose right bundling material and machine to guarantee opportune and most practical send off.
Audit and Qualify Designing Drawings, Choice of tars, Models and guarantee bundling Line Similarity
Team up with Bundling supply accomplices, for printed and unprinted bundling for all essential/optional/tertiary level.
Team up with Bundling Hardware Manufacturer(s), to qualify the Material-Machine Connection point
Obligatory Abilities
Aces in science, designing, and additionally bundling innovation. 8+ Long periods of involvement of bundling frameworks, materials and cycles for drug, cosmeceutical, haircare and oral consideration projects. Profound comprehension of Kld's, craftsmanship planning process, India marking guideline for both OTC/Gx , sealing computerized/on the web , conceal cards leeway and first stockpile endorsements. Sound information on various rankle designs , bottles , tubes , sachets , droppers, siphons, their working machines
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