Ahmedabad
INR 1.5 - 6.5 Lacs P.A.
Work from Office
Full Time
Role & responsibilities Preparation and Review of BMR/BPR/MFR Preparation and Review of Spec/STP/COA and data related to quality control. Communication with third party manufacturer for documentation related to production, quality assurance, quality control and goods Manage vendor documentation Preparation and Approval of Standard operating Procedures (SOPs). Reviewing & checking the raw material, packing materials and finished goods as per the pre-specified criteria. Responsible for review of investigation for quality deviations are conducted, approval of specifications and quality related documents. Responsible for ensuring timely party Audits, approval of Quality Related Change Controls, approval of vendor complaints. Visiting the supporting manufacturing facilities and ensuring the proper manufacturing.
Ahmedabad
INR 2.5 - 7.5 Lacs P.A.
Work from Office
Full Time
Roles and Responsibilities Responsible for preparation & compilation of the dossiers in CTD/eCTD/ACTD and other formats as required for submission to different regulatory authorities. Review the documents i.e. Specifications, Batch Records, STP, Stability Protocol, Dissolution protocols & DMF documents etc. Preparation of pharmaceutical/quality part (all forms) of registration dossiers & variations/amendments/annual reports as applicable documents in CTD and eCTD format. Preparation of query response for submitted applications received from various regulatory authorities. Responsible for review of change controls and checking for regulatory compliance for all documents. Exposure of Dossier compilation for ACTD & CTD is mandatory. Coordination with the external stakeholders for the preparation of the regulatory documents. To be responsible for the Life cycle management of assigned products. Should have experience for Life cycle management and license Maintenance. Should have good knowledge for recent guidelines, websites and trends of Europe, Africa, Mexico, LATAM region, Chile, Costa-Rica, Peru, Panama, Asian, CIS market. Desired Candidate Profile Candidate must have good knowledge of working in Europe, Africa, Mexico, LATAM region, Chile, Costa-Rica, Peru, Panama, Asian, CIS market. Perks and Benefits Best in industry. Immediate Joiners preferred
Kadi, Ahmedabad
INR 0.5 - 2.5 Lacs P.A.
Work from Office
Full Time
Job Summary: We are looking for an organized and detail-oriented Accounts Executive to manage our financial records and ensure accurate reporting. You will handle accounts payable and receivable, assist in budgeting, and support financial audits. Key Responsibilities: Financial Record Keeping: Maintain accurate financial records and ensure all transactions are recorded. Accounts Payable and Receivable: Process invoices, payments, and receipts in a timely manner. Reconciliation: Perform monthly bank reconciliations and verify discrepancies. Reporting: Prepare financial reports for management and assist with budgeting. Compliance: Ensure compliance with financial regulations and company policies. Support Audits: Assist in internal and external audits as needed. Qualifications: Bachelors degree in accounting, Finance, or a related field. Experience in accounting or finance. Strong understanding of accounting principles and practices. Proficiency in accounting software and Microsoft Excel.
Ahmedabad
INR 1.5 - 6.5 Lacs P.A.
Work from Office
Full Time
Role & responsibilities Preparation and Review of BMR/BPR/MFR Preparation and Review of Spec/STP/COA and data related to quality control. Communication with third party manufacturer for documentation related to production, quality assurance, quality control and goods Manage vendor documentation Preparation and Approval of Standard operating Procedures (SOPs). Reviewing & checking the raw material, packing materials and finished goods as per the pre-specified criteria. Responsible for review of investigation for quality deviations are conducted, approval of specifications and quality related documents. Responsible for ensuring timely party Audits, approval of Quality Related Change Controls, approval of vendor complaints. Visiting the supporting manufacturing facilities and ensuring the proper manufacturing.
Ahmedabad
INR 2.5 - 7.5 Lacs P.A.
Work from Office
Full Time
Roles and Responsibilities Responsible for preparation & compilation of the dossiers in CTD/eCTD/ACTD and other formats as required for submission to different regulatory authorities. Review the documents i.e. Specifications, Batch Records, STP, Stability Protocol, Dissolution protocols & DMF documents etc. Preparation of pharmaceutical/quality part (all forms) of registration dossiers & variations/amendments/annual reports as applicable documents in CTD and eCTD format. Preparation of query response for submitted applications received from various regulatory authorities. Responsible for review of change controls and checking for regulatory compliance for all documents. Exposure of Dossier compilation for ACTD & CTD is mandatory. Coordination with the external stakeholders for the preparation of the regulatory documents. To be responsible for the Life cycle management of assigned products. Should have experience for Life cycle management and license Maintenance. Should have good knowledge for recent guidelines, websites and trends of Europe, Africa, Mexico, LATAM region, Chile, Costa-Rica, Peru, Panama, Asian, CIS market. Desired Candidate Profile Candidate must have good knowledge of working in Europe, Africa, Mexico, LATAM region, Chile, Costa-Rica, Peru, Panama, Asian, CIS market. Perks and Benefits Best in industry. Immediate Joiners preferred
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