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3.0 - 7.0 years
0 Lacs
punjab
On-site
You will be responsible for managing the DMFs & CEPs application process, CADIFA Application, and Annual Report for USDMFs. Your role will involve utilizing your knowledge of ICH, PIC/s, and EMEA guidance to prepare and submit KDMFs, CDMFs, and JDMFs. Additionally, you will be required to handle submissions on the CESP Portal and Solicita Portal, ensuring compliance with ESG (USFDA) standards. Your tasks will also include publishing and e-Validation. - Proficiency in managing DMFs & CEPs application process - Familiarity with CADIFA Application and Annual Report for USDMFs - Knowledge of ICH, PIC/s, and EMEA guidance - Experience in compiling and submitting KDMFs, CDMFs, and JDMFs - Ability ...
Posted 5 days ago
15.0 - 20.0 years
12 - 20 Lacs
gandhidham
Work from Office
- Key Responsibilities Plan, organize, and monitor manufacturing operations to ensure timely and efficient production and dispatch of pharmaceutical formulations with accurate yield and reconciliation. Ensure compliance with cGMP norms and regulatory standards including WHO, EU GMP, PICS, TGA, MHRA, and USFDA on the shop floor. Lead process validation activities to ensure manufacturing processes meet quality and regulatory requirements. Collaborate with QA and QC departments on handling product complaints and recall analysis. Manage production schedules, coordinate with supply chain, and optimize resource utilization to meet business goals. Oversee production team performance, training, and ...
Posted 1 month ago
7.0 - 12.0 years
7 - 17 Lacs
ahmedabad
Work from Office
Job Summary: We are looking for an experienced Production Manager specializing in External Preparations (ointments, creams, gels, lotions, topical solutions, etc.) and Liquid filling line to manage and optimize pharmaceutical production activities. The successful candidate will have proven experience operating under WHO GMP, PICS GMP & EU GMP and will be responsible for ensuring high standards of quality, compliance, and efficiency in product manufacturing. Key Responsibilities: • Production Manager for oversees the manufacturing processes related to external preparation formulations & Liquid filling line. • Production Planning & Execution Develop and implement production schedules to meet d...
Posted 1 month ago
7.0 - 11.0 years
0 Lacs
hyderabad, telangana
On-site
You should have a Masters or Bachelors degree in Science / Pharmacy along with at least 7-10 years of experience in a similar function within the pharmaceutical industry. As a Regulatory Affairs professional, you must have supported regulatory affairs functions on finished dosage forms. It is essential to possess a sound and deep knowledge of current Regulatory / GMP requirements including US FDA, EU GMP, and PIC/s. Your role will require strong initiative skills, enabling you to work both independently and as part of a team. Proficiency in English communication is vital for effective coordination within the organization and with external stakeholders. Additionally, you should have advanced ...
Posted 1 month ago
7.0 - 12.0 years
7 - 17 Lacs
Ahmedabad
Work from Office
Job Summary: We are looking for an experienced Production Manager specializing in External Preparations (ointments, creams, gels, lotions, topical solutions, etc.) and Liquid filling line to manage and optimize pharmaceutical production activities. The successful candidate will have proven experience operating under WHO GMP, PICS GMP & EU GMP and will be responsible for ensuring high standards of quality, compliance, and efficiency in product manufacturing. Key Responsibilities: • Production Manager for oversees the manufacturing processes related to external preparation formulations & Liquid filling line. • Production Planning & Execution Develop and implement production schedules to meet d...
Posted 3 months ago
9.0 - 14.0 years
10 - 15 Lacs
Ahmedabad
Work from Office
Quality Manager Pharmaceutical Manufacturing Department: Quality Specialist Reports to: Director Job Summary: We are seeking a highly competent and detail-oriented Quality Manager to lead the Quality Assurance and Quality control functions at our pharmaceutical manufacturing site. The successful candidate will bring deep knowledge of WHO GMP, PICS standards, and EU GMP regulatory expectations, ensuring full compliance and continuous improvement of the Quality Management System (QMS). Key Responsibilities: • Lead, manage, and continuously improve the Quality Management System (QMS) to ensure full compliance with WHO, PICS, and EU GMP regulatory requirements. • Oversee GMP compliance, includin...
Posted 4 months ago
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