24 Job openings found

DMF API Submission experience is must Preparation of New Drug Master Files as well as DMF amendments for Brazil, US, and ROW market according to respective agencies requirements. Preparation of Applicant part of DMF for Brazil, US, and ROW market. Preparation of all administrative statements for respective authority requirements. Drafting of regulatory response for ...

Quality Assurance Administration, training, and auditing of Quality System Tools (Customer Complaints, CAPA, Training, Control Documents, Standards). Ensure compliance of quality procedures and work instructions with applicable standards. Conduct audits, training, preventive and corrective actions to maintain the QA system. Maintain training, qualification, and certification records of personnel. Approve/disapprove suppliers, vendors, facilities, equipment, processes, and ...

Job Description   -Compilation and submission of eCTD dossier for new product application (ANDA/EU-MA)/Post approval submission to the regulatory authority (specifically EU/US) -Hand on experience in preparation of CTD section as per regulatory requirements of different region -Having experience in preparation of query response and PAS, CBE and annual report. -Have ability to co-ordinate with ...

Position:         Executive - QA/RA Location:        Dabhel - Daman Experience:     5 - 8 Year Industries:      Pharma  Responsibilities: Preparation of the dossier as per the current prescribed guidelines of the respective regulatory authorities Coordinate with various departments to collect the complete set of documents. Review of the quality and analytical ...

WE ARE HIRING!!!JOB LOCATION: Bangalore,IndiaDEPARTMENT: Verification and ValidationREQUIRED EDUCATION: Bachelor’s degree in EC/Biomedical engineeringKEY RESPONSIBILITIES: • Review product, user and technical system requirements forcompleteness, feasibility, and testability of the product and/orsystem• Define and implement system integration and test protocols(including embedded, mobile and web services software, as wellas electrical and mechanical ...

Job Location : Mahape, Nearest Station Ghansoli (Navi Mumbai)   Look for people from Navi Mumbai or Mumbai Only   Only Female Candidates required   Qualification : B.Pharm / M.pharm   Experience : 1yr – 3yr   Salary : 1.42lpa – 2 .80lpa     Profile : Experience in preparing Dossiers in CTD, ACTD, Country Specific Dossiers.   Countries : ROW and Latum   Job Description: Dossier Preparation along ...

KEY RESPONSIBILITES: • Team Handling.• Assist/guide team member to enable them for below: Ensure timely compilation & submission with best quality of Dossiers, (Asia, Africa, CIS and LATAM) and maintain proper records of the same.• Handling queries for Asia, Africa, CIS and LATAM.• Query tracker updates on weekly basis.• Timely response ...

Role: • Preparation and review of Electronic Common Technical Document (eCTD), PSUR. PADER or RMP in compliance with EU and US standards and protocols. • Write, edit clinical study protocols. clinical study reports, summary documents, investigator brochures, portions of regulatory briefing documents and development safety update reports. • Drafting and revising pre-clinical summaries. • ...

Position:        RA Executive Location:       Daman Experience:    2 - 3 Years Industries:     Pharma Responsibilities: Preparation of the dossier as per the current prescribed guidelines of the respective regulatory authorities Coordinate with various departments to collect the complete set of documents. Review of the quality and analytical data as per the pharmacopoeia, specification, ...

Dossier preparation as per the ACTD & CTD (Module I, II, III, IV and V) guideline. Technical documents like Raw Material and finished products specification, manufacturing process, Product development report, stability reports, process validations preparation & review. Analytical method validation review as per the ICH guideline. Drug Master File review Technical query response to the ...