Officer, Raw Materials
Required Experience of: Receipt, storage and dispensing of Raw Material & Packaging Materials as per their respective Sops. Online documentation for all transactions of materials and all activities wh
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Required Experience of: Receipt, storage and dispensing of Raw Material & Packaging Materials as per their respective Sops. Online documentation for all transactions of materials and all activities wh
Description: To ensure compliance with cGLP regulations by analysis and calibration of all aspects of Quality Control at the manufacturing site To work as key core team member for LIMS activities. Pre
Good knowledge of ANDA submission activities and post-approval procedures and related ICH and USFDA guidelines. API DMF and DMF Change Notification review with respect to USFDA regulatory requirement.
Description: Good knowledge of ANDA submission activities and post-approval procedures and related ICH and USFDA guidelines. API DMF and DMF Change Notification review with respect to USFDA regulatory
Good knowledge of ANDA submission activities and post-approval procedures and related ICH and USFDA guidelines. Exposure of the Solid oral dosage form / Sterile dosage form / complex dosage form / top
Description: Good knowledge of ANDA submission activities and post-approval procedures and related ICH and USFDA guidelines. API DMF and DMF Change Notification review with respect to USFDA regulatory
Description: Good knowledge of ANDA submission activities and post-approval procedures and related ICH and USFDA guidelines. Exposure of the Sterile dosage form / complex injectable dosage form and br
To follow safety rules in the premises according to the company norms. •Timely completion of SOPs Training and On the job trainings related to respective area. •Responsible for the operation and clean
To follow the safety rules in the premises according to the company norms. •To maintain online the BMRs and other log books in the respective area as per cGMP and SOP. •Timely completion of SOPs train
Key Responsibilities: 1. CSV Strategy & Governance - Develop and maintain the overall CSV strategy and validation master plans for global systems. - Ensure compliance with GAMP 5, USFDA, EU Annex 11,
Description: Responsible to look after overall plant activities i.e. Regulatory Compliance and Quality Control, Strategic Planning and Management, Production Management, Financial Management, Human Re
Description: Responsible for implementing and maintaining Process Safety Management (PSM) systems to ensure safe plant operations. Conducts hazard identification studies, risk assessments, HAZOP revie
Description: This role is responsible for defining and specifying the activities, processes, and standards required to fulfill quality requirements for manufactured materials, components, and products
Description: This role supports the in-process quality assurance function within a pharmaceutical manufacturing environment, contributing to the definition and specification of activities, processes,
Description: The role is responsible for ensuring effective day-to-day technical support to employees across a range of hardware and software systems. Handle QMS Activities. Support Laboratorty shop f
Key Responsibilities: Secretarial Function: Manage the secretarial compliances. Board & Shareholder Meetings: Organize, conduct, and document meetings of the Board of Directors and shareholders. Compa
Create and manage purchase orders of Excipients for all plants commercial requirements. Ensure timely follow-up and delivery coordination with SCE team to support uninterrupted production schedules. C
Responsible for overall QA function compliance with various regulatory guidelines and standard operating procedures in practice at the site. Review and monitor quality systems and provide guidance to
Responsible for document management like BMRs, BPRs, master SOPs etc.. Responsible for preparation & review of the master documents of production. Responsible to ensure UAF working in area. Responsibl
Responsible for line clearance activity before commencing the different operations like dispensing, manufacturing, filling, inspection, sealing, labelling, and packing. Responsible for Process validat
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