An ambitious and coordinated individual with a good amount of industrial experience seeks a managerial position with a company that utilizes my management and comprehension abilities and expertise.
Supervising, leading, training and mentoring all QC department staff.
Reviewing and approving SOP’s, Validation Protocols and Validation Reports related to QC department and other documents.
Preparing the Form-5 for renewal and updation of registration of all kind of drugs.
Planning and allocating day to day activity.
Managing QC & Microbiology lab with required documentation.
Managing, planning and directing the work activities of QC & Micro labs to ensure lab testing provide the highest quality analytical support for manufacturing.
Implementation of Good Lab Practices in the QC lab.
Leading the Projects of ISO 9001:2015 (Quality Management System), ISO 14001:2015 (Environment Management System) and OHSAS 18001:2017.
Implementation of QMS (Quality Management System in organization.
To ensure that all the necessary sampling, testing and calibration is carried out as per the approved specifications and SOP’s.
Preparation and validation of method of analysis of raw materials and Finish Products and bulk products.
Preparation of dossiers according to DRAP requirements for approval of Form-7 of products.
Development and implementation of validation protocol, Method validation and Process validation
Review budget for Quality control Lab consumables, ensure that Quality Control operations of the company are cost effective and efficiently managed.
Stability program that includes both real time study and accelerated stability study as per GMP and ICH Guidelines.
Preparation and updating of SOP’s for all instruments.
Preparation of method of Analysis and Specification of Raw material, packaging material, intermediate, bulk, finished product and stability products.
Stability program that includes both real time study and accelerated stability study as per GMP and ICH Guidelines.
Qualitative and quantitative testing of raw materials and finish products by using UV/VIS spectrophotometer, HPLC, FTIR, kjeldahl apparatus, AAS and Potentiometer as per SOP and pharmacopeia guideline.
Development of testing methods for non-pharmacopoeial raw materials, finished products and their Analytical Method Validation.
Prepare the certificate of analysis for raw materials and finished products.
Perform inprocess quality assurance checks for tablets, capsules and liquid orals.
Issuing of line clearance at every step of batch manufacturing.