Sr.Executive / Asst.Manager - API Sourcing(Formulation)

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 :

Ø  Source Evaluation and Finalization for suitable Injectable grade API

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

Ø  API samples / Impurities / Working standards support for Formulation development stage.

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

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

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

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

Ø  Completion of Vendor qualification & vendor Audits as per CQA SOP

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

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

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

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

Ø  API support for Launch and commercial execution at plant level.

Ø  Alternate 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 Pharma or 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.

Skills Required

Negotiation, Formulation, Regulatory Compliance, Supply Chain, Vendor Management, Quality Control