5.0 - 7.0 years

0 Lacs

ankleshwar, gujrat, india

On-site

Position title: ESO QA Specialist University degree in Pharmacy, Chemistry, Biology, or relevant Life Science Minimum of 5 years in a similar role or equivalent experience in a GMP-related environment Job location - Ankleshwar, Gujarat, India MISSION STATEMENT To ensure the quality lifecycle management for dedicated, subcontracted, product portfolio. Qualified auditor. Main Accountabilities And Duties Operational skills Operational quality management of a dedicated product portfolio which includes: Quality management of deviation and complaint records and their related CAPAs Assessment and management of change controls Edition of QA Agreements with Zentiva third parties and subcontractors Co...

Posted 1 month ago

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Quality Sr Specialist Teva Pharmaceuticals

3.0 - 5.0 years

0 Lacs

bengaluru, karnataka, india

On-site

Who We Are Together, we're on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It's a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world's leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization's Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we're always looking for new ways to continue making a difference, and new people to make a difference with. Ho...

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Executive/Senior Executive - FR&D Injectables / OSD) Cronus Pharma

2.0 - 5.0 years

6 - 7 Lacs

hyderabad

Work from Office

Role & responsibilities Job description Perform protocol for drug excipient compatibility studies and submit the protocol for review and approval Complete lab. experiment hands-on independently (Lab scale to exhibit batch and query handling). Dosage forms experience: Injectables predominantly more than 90% in career. Perform formulation development activities on differentiated formulations and innovative technologies as part of product development. Carry out /Support Scientific literature search (CVM/USFDA/Daily-med/publications). Follow good laboratory practices, good documentation practices (online LNB writing) and maintain the logbooks and forms for equipment/instruments. Compilation, int...

Posted 2 months ago

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Manager- CMO SUN PHARMA

10.0 - 14.0 years

0 Lacs

vadodara, gujarat

On-site

As Manager 2 in the Corporate Quality department at SUN Pharma, you will be responsible for overseeing the quality aspects of contract manufacturing organizations (CMOs) involved in manufacturing site transfer products for the US market. Your primary focus will be to ensure compliance with SUN Pharma Quality and Compliance Standards as well as global regulatory requirements. Your essential job functions will include monitoring and overseeing activities at CMO sites to ensure adherence to SUN Pharma standards and regulatory guidance. You will conduct regular oversight visits, prepare visit reports, and serve as the main point of contact for coordination between SUN site, commercial team, corp...

Posted 4 months ago

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Regulatory Affairs-CMC- Queries Aurobindo Pharma

1.0 - 3.0 years

1 - 3 Lacs

Hyderabad, Telangana, India

On-site

Preparation, review and compilation of assigned ANDA/NDA [505 b (2)]/projects for filing and knowledge of eCTD, Module 2 and 3. Hands on experience in reviewing CMC documents of Solid and Liquid Oral Dosage forms. Preparation, review and compilation of Supplements and Amendments. Review of Pharmaceutical Development Reports Review of manufacturing documents like batch manufacturing records, batch packaging records, yield and reconciliation, manufacturing summaries, hold time study reports, master formula cards, master packaging cards etc. Review of analytical documents like specifications, test procedures, method equivalency reports, method validation/verification reports and method transfer...

Posted 4 months ago

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Technical Documentation Executive Prominent Consultant

2.0 - 4.0 years

4 - 5 Lacs

Ankleshwar

Work from Office

Must to have experience in COA/ Certificate of Analysis, MSDS, Specifications/ TDS, Method of Analysis, Stability Data, DMF/ Drug Master File. Must have knowledge of Pharmacopoeias, ICH guidelines.

Posted 5 months ago

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