To develop, ensure, implement and maintain a GxP compliant Laboratory systems.
To ensure training and effective implementation of current Good Laboratory Practices.
To establish and ensure analysis, approval / rejection of starting materials, packaging materials, intermediate, bulk & finished products as per validated Pharmacopoeia / In house method for Oral Dosages and LVP facility.
To ensure that the appropriate validations, including analytical procedures, and calibrations of equipment are done.
To Ensure the Maintenance of the Department, Premises and Equipment.
To ensure all necessary testing and stability studies are carried out for Oral Dosages and LVP facility as per the approved specifications and applicable guidelines.
To ensure that the specifications and the testing methods are in line with the latest guidelines and applicable pharmacopoeias .
To approve specifications, sampling instructions, test methods & other Quality control procedures for oral and liquid injectable facility.
To approve and monitor all contract analysis.
To Ensure the required initial and continuing training of Quality Control personnel is carried out and adapted as per requirement.
To assist in the investigations related to the laboratory, product failure, incidents and Risk assessments.
Review and disposition of the non-conforming materials in co-ordination with Quality Assurance.
To ensure the compliance of the Quality Management System and CAPA effectiveness related to the Laboratory.
To apply total quality management tools and approaches to analytical and reporting processes.
Create and direct environmental monitoring programs in line with the regulatory requirements. To continuously review quality control processes, procedures and capabilities in order to sustain the most cost effective and efficient methods for meeting quality requirements and making recommendation for improvement as appropriate.
To monitor and report quality control progress, notify any discrepancies or potential concerns to the site Quality Head.
Support the development of quality goals and targets as part of the organization’s strategic plan.
Maintain active role on internal continuous improvement initiatives.
To Design, develop and implement quality control training programs.
To ensure the self-training in the ISO train within the stipulated time frame. Business Administrator for Darius System, to ensure the review and approval of documents in Darius.
To be responsible for Laboratory Quality management system and internal Audit as per NABL ISO / IEC 17025.
In absence of the position holder, the Manager / Group manager working in the respective section or shall be responsible for day to day working.