Job Description

Opening in Purchase Department for Strategic Sourcing – Oral / Injectable API – Formulations

Position: Asst Manager / Dy. Manager

Experience : 8-12 Years

Purpose:

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

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

Key Responsibilities:

  • Source Evaluation and Finalization for suitable Oral/Injectable grade API.
  • Support Formulation R&D in arranging the materials for development, optimization, confirmatory & exhibit batches which are under development in Hyderabad surround locations.
  • API samples / Impurities / Working standards support for Formulation development stage.
  • Documents support and co-ordination with License team for License applications (Test license / API import License / Advance license.
  • Support AR&D/QC in arranging the required documents from vendor for method transfer & specification finalization.
  • Supporting for product Transfers from FR&D to Formulations Vendor qualifications & material delivery's as per project timelines.
  • Handling of technical issues for internal & outsourced materials by arranging meetings & telecom’s where ever required.
  • Completion of Vendor qualification & vendor Audits as per CQA SOP.
  • Timely release of Purchase Order's & Follow-up with vendors for materials delivery as per schedules.
  • Closure of all the open issues to enable QC/QA approval of materials.
  • Execution of Agreements (Quality agreement / Supply agreement with co-ordination with Legal dept.
  • Co-ordinations with cross functional teams for vendor qualification / vendor facility audits/ drug master files evaluation and IP evaluation and suitable grade finalization.
  • API support for Launch and commercial execution at plant level.
  • 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 having a relevant experience in API sourcing function for US, EU and emerging markets.


Job Details

Role Level: Mid-Level Work Type: Full-Time
Country: India City: Hyderabad ,Telangana
Company Website: http://www.hetero.com Job Function: Procurement & Vendor Management
Company Industry/
Sector:
Pharmaceutical Manufacturing

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