DESCRIPTION DU POSTE:

Sous la supervision du Superviseur ‘ICRO Validation, le Rédacteur Scientifique écrit les protocoles, méthodes et rapports décrivant la validation des méthodes analytiques selon les critères de validation de Neopharm Labs ou ceux de ses clients. Il doit pouvoir rédiger les documents en anglais pour répondre aux besoins des clients et pour les transmettre aux autorités réglementaires concernées tout en se conformant aux bonnes pratiques de fabrication (BPF) et aux procédures opératoires normalisées (PON).

JOB DESCRIPTION:

Under the supervision of the Micro Validation Supervisor, the Scientific Writer drafts protocols, methods, and reports describing the validation of analytical methods according to Neopharm Labs’ validation criteria or those of its clients. He or she must be able to write documents in English to meet client needs and submit them to the relevant regulatory authorities while complying with good manufacturing practices (GMP) and standard operating procedures (SOPs).

• Write and verify methods, protocols, reports, and all relevant micro validation, transfer, or study documents produced by the validation team in accordance with Neopharm procedures and client requests;
• Verify or correct raw data to ensure that it contains everything required by the appropriate validation protocol and meets GMP criteria;
• Communicate with customers for document revisions and corrections;
• Communicate with laboratory staff to obtain or clarify any information necessary for the drafting of validation documents;
• Immediately inform the supervisor if a method does not meet a validation criterion;
• Ensure the implementation of validated methods in the current database for use in the laboratory;
• Review methods and the quality documentation required to support these reviews (e.g., Change Control) when requested by a customer or Neopharm operations;
• Manage validation files and coordinate their archiving;Perform any other related tasks assigned by the immediate supervisor or required by the