Associate PS&T

JobItUs; Mumbai; On-site; INR 1,500,000 - 2,200,000; Part time

Job summary

JobItUs in Mumbai (On Contract) seeks an Associate PS&T with 7–10 years of experience in manufacturing and technology transfer. The role involves gap analysis, master formula records, and transfer protocols for identified products.

The candidate will review manufacturing documents, support NPIs, validate batches, and ensure reproducibility in commercial production while maintaining regulatory compliance.

Qualifications

• 7–10 years of experience in pharma manufacturing/tech transfer.
• Experience with process validation and documentation review.
• Knowledge of GLP/GMP and compliance standards.

Responsibilities

• To perform effective gap analysis between sender & receiving site in process & equipment and to provide solution for smooth technology transfer.
• To prepare Master formula record & Technology transfer protocol for products identified for transfer.
• To Review receiving site’s draft documents pertaining to manufacturing, process validations & analysis of product under transfer & executed documents post validation.
• To execute validation batches and to ensure validation batch reproducibility is demonstrated in commercial batches.
• To review executed process validation batch documents & support FLQR.
• To extend technical support and batch execution (as applicable) to activities like Alternate Supplier Qualification.
• To extend support to NPI activities like Dossier review, Site visit, Product certification & FLQR.
• To monitor Engineering batches/ PV batches at Site for I&D transferred products. Review of Pre and Post execution batch documents.
• To keep track of ongoing projects and update senior management beforehand.
• To provide Technical support in Shelf life extension of all TPM products.
• To provide technical support in compendial compliance in existing products
• Preparation of Specifications and STP’s for Finished Product and raw materials including excipients for LL products.

Skills

Technology transfer

Process validation

Documentation

Quality systems

Education

B.Pharm

M.Pharm

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/7738039618