Executive/ Senior Executive - Purchase API Sourcing (Formulation)
Hetero
Date: 1 day ago
City: Hyderabad, Telangana
Contract type: Full time
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
Academic Background & Experience Required:
B. Pharma/M Pharma or Post Graduate in Science with at least 8-10 years of experience, with having an relevant experience in API sourcing function for US and emerging markets.
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
Academic Background & Experience Required:
B. Pharma/M Pharma or Post Graduate in Science with at least 8-10 years of experience, with having an relevant experience in API sourcing function for US and emerging markets.
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