Head Quality Control
Abbott
Quality Assurance
Baddi, Himachal Pradesh, India · India · Baddi, Himachal Pradesh, India
Posted on Jun 2, 2025
Following will be the responsibilities of the position holder :
- 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.
Minimum Education