12 Job openings found

Job description for API Regulatory: Preparation, review and submission of Drug Master Files/CEP in eCTD format for the regions US, EU through ESG and CESP. Life cycle management of the Drug Master Files (Amendments, Annual Reports, CEP updates). Preparation, review and submission of Applicant's Part DMF (Open Part DMF) and Technical data ...

Key Skills: Process improvements, Analyzing information, strategic planning, verbal communication,improving others, good numerical skills, understanding of statistics, good IT skills, awarenessof ISO/TS/FSSC/CGMP/Type III DMF(USA) system, emphasizing excellence, attention todetails, thoroughness, problem solving. Key Tasks Overall responsible for quality of product produced. Ensure to maintain & validate the entire document as per ISO-22000:2018 ...

  Role & responsibilities   Design, finalize and propose specification of KSM, Intermediates and finish API as per developed control strategy. Prepare the documents for Process development report and technology transfer. Develop cost effective, high quality and minimum environmental hazardous process considering ICH guideline. Finalize the route of synthesis after doing feasibility study of ROS to ...

Job Description:  Experience in handling regulatory affairs for ROW market mainly Central and Latin American, African & Asian countries for Pharma Formulations. ? Preparation, Compilation & Review of Registration documents that include Administrative & Technical. ? Reviewing the technical documents provided by QA, QC, Production providing them the report of shortcomings & ...

Roles and Responsibilities  -Need Injection / Extrusion Moulding Background-Break down & Preventive maintenance of Moulding machines, Press shop m/cs , Press shop,Powder coating plant,Laser marking m/cs Utilities,Tool Room m/c , LT & HT panels etc-Inhouse repairing/ outsourced repairing - Candidates must be from a DMF / FDAA Approved Organization, that is currently ...

We are looking for an experienced Production Manager to organize and oversee the manufacturing of goods. You will be ultimately responsible for the smooth running of all production lines and the quality of output. We expect you to have deep know-how in production procedures. Ability to direct personnel towards maximum ...

Lead PLANT QA handling MANUFACTURING QUALITY/IPQC, SUPPLIER QA, CUSTOMER QA or QMS focusing on QA MIS, SHIFT QA, OEM COMPLIANTS REDRESSAL etc & strong exp in INJECTION MOLDING QUALITY PROCESSES for FDA approved DMF grade Pharma packaging products.  Required Candidate profile5+yrs exp with Blow/ Injection Molding Units handling either IN-PROCESS QA, ...

2-5 years of working experience on Dynamics 365 F&O and Dynamics AX Knowledge of Coding in X++, MorphX, SSRS Report development, .net mandatory Knowledge of working on previous versions of AX (2009,2012,2012 R2/R3) Knowledge of building SQL queries for analytical requirement of Dynamics database Familiarity with DevOps, TFS, LCS Knowledge/experience of various integration methods like ...

Description:  We have an urgent opening for the position of R&D Chemist for a leading organization for Mahape (Navi Mumbai) location. Company Profile: Company was founded by a group of technical experts. It is in the business of providing Analytical services, Formulation Development, Impurities synthesis, supplying of APIs and Fine chemicals to the Pharmaceutical Industry. It is ...

Description:  We have an urgent opening for the position of Analytical Chemist for a leading organization for Mahape (Navi Mumbai) location. Company Profile: Company was founded by a group of technical experts. It is in the business of providing Analytical services, Formulation Development, Impurities synthesis, supplying of APIs and Fine chemicals to the Pharmaceutical Industry. ...