Ztmp Regulatory Affairs
2 weeks ago
Department
- ANKLESHWAR MFG. U1
- Job posted on
- Aug 26, 2024
- Employment type
- P-P8-Probationer-HO Executive
- The job requires **review of documents related to DMF** submission against predefined checklists and submission to various agencies globally.
- Should keep the all the **regulatory database up to date**.
- Assessment of change controls (QMS) with reference to **regulatory impact as part of life cycle management to meet business requirement.**:
- Should keep knowledge up to date with regard
- To regulatory guidelines and requirements in all global regions as well as for new technical trends.
- Should be energetic, determined to be successful, and able to deal with new or difficult situations easily.
-
Ztmp QA
2 weeks ago
Ankleshwar, India Zydus Group Full timeDepartment - ANKLESHWAR QA -U2 - Job posted on - Feb 12, 2025 - Employment type - C-C8-Confirmed-HO Executive Total Experience: Min. 03 years - Preparation and Review of APQR - To verify implementation of recommendations. - Handling of software qualification activity at site. - Preparation, review and control of quality document management system - To...
-
Ztmp - Gmp Coordinator
2 weeks ago
Ankleshwar, India Zydus Group Full timeDepartment - ANKLESHWAR MFG. U2 - Job posted on - Feb 12, 2025 - Employment type - C-C8-Confirmed-HO Executive Qualification : M.Sc / B.E (Chemical) Total Experience : Min. 04 years - To initiate change control, preparation of draft documents (Existing and proposed) of change control. To discuss the changes with QA and to take approval. - To initiate...
-
Ztmp - Pilot Plant Production
2 weeks ago
Ankleshwar, India Zydus Group Full timeDepartment - API R&D-DBH - Job posted on - Feb 12, 2025 - Employment type - C-C5-Confirmed-R&D Staff Total Experience - 3 to 5 years of experience M.Sc. in Chemical Engineering - should have exposure to handling and supervision of equipment like reactors, centrifuges, filters, dryers, and clean room equipment of API / Bulk Drug Manufacturing. - Basic...
-
Quality Assurance
2 days ago
Ankleshwar, India Zentiva Group, a.s. Full timeAssistant Manager - Regulatory Affairs You will have the opportunity to: - Ensure compliance with regulatory requirements and support successful registration and approval of manufactured products - Preparation of high quality documents for Drug Product and Drug Substance as part of Product Life cycle management, New MAA, Response to HA Queries - Management...
-
Senior Executive
2 weeks ago
Ankleshwar, India Zentiva Group, a.s. Full timeJob Title: Sr. Executive - Quality Compliance (Supplier Quality Assurance) Department: Quality Compliance Reports to: Quality Compliance Manager Location: Ankleshwar Position Type: Full-time Qualifications and Experience: Education: B.Pharm / M.Pharm / M.Sc in Chemistry, Biotechnology, or related field. Experience: Minimum 6–8 years of experience in...
-
Assistant Manager
2 weeks ago
Ankleshwar, Gujarat, India Zentiva Full time ₹ 5,00,000 - ₹ 25,00,000 per yearJob Title:Assistant Manager - Quality Compliance (Supplier Quality Assurance)Department:Quality ComplianceReports to:Quality Compliance ManagerLocation:AnkleshwarPosition Type:Full-timeQualifications And ExperienceEducation: B.Pharm / M.Pharm / M.Sc in Chemistry, Biotechnology, or related field.Experience: Minimum 6–8 years of experience in Quality...
-
Job Title: Assistant Manager
2 weeks ago
Ankleshwar, India Zentiva Group, a.s. Full timeJob Title: Assistant Manager - Quality Assurance, Chemistry Education / Experience M. Sc. Industrial Chemistry / B. Pharma / M. Pharma having 8 to 10 years in API industry with related experience in the following fields: QA, Manufacturing & GMP. KEY ACCOUNTABILITIES 1. Quality Management/Continuous Improvement Management and control of SOPs, Master...
-
Quality Alert Expert
2 weeks ago
Ankleshwar, India Zentiva Group, a.s. Full timeJOB DESCRIPTION Position: Quality Alert Expert MANDATORY REQUIREMENTS Graduated / Post-graduate in Pharmacy/Medicine or Chemistry 10 to 12 years minimum experience in Quality or Regulatory Affairs Experience obtained in pharmaceutical manufacturing sites (+5 years). Skilled in the usage of IT tools (for example: Trackwise, Share/DrugTrack, eDMS), . English...
-
Quality Alert Expert
1 week ago
Ankleshwar, India Zentiva Group, a.s. Full timePosition: Quality Alert Expert MANDATORY REQUIREMENTS - Graduated / Post-graduate in Pharmacy/Medicine or Chemistry - 10 to 12 years minimum experience in Quality or Regulatory Affairs - Experience obtained in pharmaceutical manufacturing sites (+5 years). - Skilled in the usage of IT tools (for example: Trackwise, Share/DrugTrack, eDMS),. - English speaker...
-
Senior Executive
2 weeks ago
Ankleshwar, India Zentiva Full timeJob Description Job Title: Sr. Executive - Quality Compliance (Supplier Quality Assurance) Department: Quality Compliance Reports to: Quality Compliance Manager Location: Ankleshwar Position Type: Full-time Qualifications And Experience - Education: B.Pharm / M.Pharm / M.Sc in Chemistry, Biotechnology, or related field. - Experience: Minimum 68 years of...