[Immediate Start] Sr.Executive/Asst.Manager

3 weeks ago

Hyderabad, India Hetero Labs Limited Full time

Job Description

API Sourcing for Formulation

Position: Sr. Executive/Asst. Manager

Reporting To:Sourcing Head

Location: Corporate, Hetero Nexity, Raidurg.

Purpose:

The role involves handling Sourcing & procurements of APIs for US, Europe and emerging markets of Injectable formulation

The role offers various challenging opportunities like strategy building, vendor development, negotiations and technical issue resolving, delivering products.

Key Responsibilities:

ؠSource Evaluation and Finalization for suitable Injectable grade API

ؠSupport Formulation R&D in arranging the materials for development, optimization, confirmatory & exhibit batches which are under development in Hyderabad surround locations

ؠAPI samples /Impurities/Working standards support for Formulation development stage.

ؠDocuments support and co-ordination with License team for License applications (Test license / API import License/ Advance license

ؠSupport AR&D/QC in arranging the required documents from vendor for method transfer & specification finalization

ؠSupporting for product Transfers from FR&D to Formulations Vendor qualifications & material delivery's as per project timelines

ؠHandling of technical issues for internal & outsourced materials by arranging meetings & telecom's where ever required

ؠCompletion of Vendor qualification & vendor Audits as per CQA SOP

ؠTimely release of Purchase Order's & Follow-up with vendors for materials delivery as per schedules

ؠClosure of all the open issues to enable QC/QA approval of materials

ؠExecution of Agreements (Quality agreement / Supply agreement with co-ordination with Legal dept.

ؠCo-ordinations with cross functional teams for vendor qualification / vendor facility audits/ drug master files evaluation and IP evaluation and suitable grade finalization.

ؠAPI support for Launch and commercial execution at plant level.

ؠAlternate vendor development (AVD) of Injectable grade APIs for all markets.

Knowledge:

Basic knowledge of SAP in MM module

Good knowledge of the regulated market, vendors base

Overall understanding of Formulation Development/Project operations

Operating Network

Internal:FRD, ARD, RA, CQA, CQC, IPR, Stores, Formulations, API Mfg. plants Project Management, Finance, Internal Auditors.

External:External Vendors,

Academic Background & Experience Required:

B. Pharma/M Pharmaor Post Graduate in Science with at least 4-10 years of experience, with having an relevant experience in API sourcing function for US and emerging markets.

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