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.