Amico Formulations LLP

Vadodara, Gujarat

Reviewing documentation relating to raw materials and the release of raw materialsReviewing and Preparing batch release documentationReviewing and Approval of QA-controlled documentation (such as SOPs, batch records, working instructionsAuthorization of all procedures and standard instructions of process, controls etc Investigation and closure of all deviations, OOS and complaintsConducting self inspections.Conducting vendor evaluation of raw materials. Should have sound knowledge of Process validation. Should be familiar with preparation of process validation protocol and report.Should have sound knowledge of QMS System and Change Control , Deviation and CAPA Procedure.Review of Preventive maintenance & calibration of equipment and systems.Review of stability data to support retest or expiry dates and storage conditions and/or intermediates where appropriate.Risk analysis evaluationPerforming product quality reviews.Must understand standard operating procedure.

Regulatory Affairs ExecutiveLocation: Vadodara, GujaratMust have Experience in Pharma Industry Must have experience in handling regulatory affairs for ROW market mainly Central and Latin America and Africa 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 & ensures them to correct the documents. Handling RFIs (Requested Further Informations) queries raised by Importer/ Agent/ Regulatory authorities during evaluation of technical data. Coordinating concerned (QA, QC, Production, Packing & Purchase) departments in the process of sample preparation. Coordinate & submission of CTD/ACTD/Country Specific Dossiers/DMF (OP) to regulatory agencies. Coordinate & provide support to team for preparation and dispatch of regulatory documents & dossiers in agreed time-frames. Responsible for planning, coordinating and managing day to day regulatory affairs activities in a timely manner. Providing technical knowledge of the data used in CTD, ACTD & Dossiers to members of regulatory team. Fill up customer questionnaires by collecting information from various concerned departments. You should be good in man - management & co - ordination with all the departments Interact with various administrative, legal & factory departments to collect documents required for regulatory compilation on time. Maintenance of the complete history of each drug product

Post: Graphic Designer ExecutiveLocation: Vadodara, GujaratPharma Industry Designing of Carton, Label, Literature and Visual Aid Alu Foil as per chain part mock up Should have knowledge of CorelDraw, Photoshop and Autocad Check the 4 Colour Job while printing Knowledge of step & repeat of artwork Time Management