Job Description:
Role: Associate PS&T;
Job Type: ON CONTRACT
Contract Duration: AUTO RENEWABLE EVERY YEAR
Payroll Company: TALISMAN
Location: BKC, Mumbai
Department: Manufacturing Science & Technology
Division: Established Pharmaceuticals
Education Qualifications: B. Pharm / M. Pharm
Work Experience:
- Total experience (in years): 7 Years – 10 years
- Work Background: Manufacturing & Documentation
Primary Job Function & Core Job Responsibilities:
Core Job Responsibilities -
1. To perform effective gap analysis between sender & receiving site in process & equipment and to provide solution for smooth technology transfer.
2. To prepare Master formula record & Technology transfer protocol for products identified for transfer.
3. To Review receiving site’s draft documents pertaining to manufacturing, process validations & analysis of product under transfer & executed documents post validation.
4. To execute validation batches and to ensure validation batch reproducibility is demonstrated in commercial batches.
5.
To review executed process validation batch documents & support FLQR.
6. To extend technical support and batch execution (as applicable) to activities like Alternate Supplier Qualification.
7. To extend support to NPI activities like Dossier review, Site visit, Product certification & FLQR.
8. To monitor Engineering batches/ PV batches at Site for I&D; transferred products. Review of Pre and Post execution batch documents.
9. To keep track of ongoing projects and update senior management beforehand.
10. To provide Technical support in Shelf life extension of all TPM products.
11. To provide technical support in compendial compliance in existing products
12. Preparation of Specifications and STP’s for Finished Product and raw materials including excipients for LL products.
WhatsApp link: https://wa.me/(phone hidden)
If Interested, please drop your CV on
[email protected] or send it to (phone hidden).
📌 Opening for Associate PS&T | health care company | Mumbai Location
🏢 Talisman HR Solutions
📍 Mumbai