Job Description

:


• Responsible for the planning and supervision of all QC labs finished products and maintain online compliance in all activities.


• To assign the work for analysts and supervise the analysis of finished products and ensure on time completion of analysis.


• To coordinate with Production plants for planning of analysis.


• Handling and supervision of Technology transfer projects.


• To check and ensure proper usage of all the QC equipment.


• To train the QC personnel on all the applicable procedures, specifications, testing methods and qualify analysts to perform various QC analysis.


• Processing and approve for all HPLC &GC analytical data for all analysts, review and check all the Audit trial for all the instruments.


• To train the QC personnel on all the applicable procedures, specifications, testing methods and qualify analysts to perform various QC analysis.


• To prepare and revise the SOPs and work instructions.


• To ensure the analysis are performed correctly as per applicable procedures and the raw data is checked for correctness, accuracy and compliance.


• To perform investigation for the lab incidents, OOS, OOL results, deviations and take appropriate corrective and preventive actions.


• Follow up &Close all the EQMS actions ( CAPA , OOS , Deviations , CCF )


• To lock the results in SAP, to create notifications & reservations for maintaining enough stock of chemicals & consumables.


• To involve and support in external and internal audits and to close the audit observations on time.


• Review and approve protocols and reports such as method validation, method transfer, process validation and stability.


• To handle and close the Quality management system actions like Deviations, OOS, CAPAs, AMS and Change controls using Amplelogic system.


• To follow and ensure data integrity and good documentation practices are implemented in the QC labs.


• To ensure and follow GLP, GMP, safety procedures and maintain hygienic conditions in lab.


• Shall be authorized designee for responsibilities of QC Sr Manager.
• Apart from above, the works assigned by the Head of the department/designee.




Core Competencies:


• Bachelor's degree in Pharmacy / Science.


• Proficient with computer software application


• In terms of competency you are highly result oriented with strong sense of accountability & ownership.


• High on communication and collaboration, having an ability to manage multiple stakeholders at a time.
• Strong eye for details, having expertise to understand, review and implement the compliance inputs from Quality point of view.
• In-depth knowledge of the industry's standards and regulations guidelines excellent knowledge of reporting procedures and record keeping.


• Must be able to manage tasks and priorities and easily adapt to changing situations.


• Ability to create cross functional relations and manage conflicts.


• Problem Solving and high agility on taking right scientific decisions.