The job description is as below:
- Finding business partner for plant In-Licensing.
- Introduction of Recent Third Party and Loan Licensing (Out Licensing)
- Having contacts with Formulation suppliers of various dosage forms.
- Knowledge of transfer price negotiations, current API rate of all dosage forms.
- To handle QA activities of Loan License / P to P sites like site visit, verification of finished goods, Joint analysis, Market complaint investigation, validation and other activities as per requirement.
- To review quality documents like BMR, BPR, Process validation protocol / report, Hold time study data, PQR etc. prepared at LLM or P to P site.
- To prepare and review SOPs of procedures for loan licence and/or third party manufacturing.
- To handle and review change control for loan license product at loan license location.
- To handle Deviations, CAPA, Market complaint, OOT, OOS and other QMS related activity with regular follow up of loan license location.
- To coordinate with RA Departments for different type of documents requirements for registration purpose about third party manufacturing products.
- To update the knowledge pertaining to standard operating procedures relevant to them in the development and current good manufacturing practices.
- To handle the vendor qualification related activity and ensure vendor audit and compliance as and when require.
- To plan and execute day to day activity report of LLM sites and follow up to our executives.
- To prepare, review and maintain quality technical agreements for third party manufacturing sites.
- To release / reject the packed goods for sale after verification of party COA and pre dispatch inspection (If applicable) of Loan License and P to P products.
- To review the technology transfer documents as and when new products transferred or revision takes place in the document related to respective loan licence location.
- To coordinate with PPMC department to ease execution of manufacturing
📌 Urgent opening for the position of the Business development executive for pharmaceuitical company based as Ahmedabad
🏢 POST A RESUME
📍 Ahmedabad
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