Deputy Manager
SUNMAN-BIRDEM Pharma Ltd.
Total years of experience :14 years, 1 Months
Develop and maintain quality standards that apply to product development, ensuring cGMP and safety regulations.
Plan and track quality control objectives, timelines, priorities, and resources.
Review and approve protocols and reports such as method validation, method transfer, process validation and stability.
Identify, analyze and resolve problems and issues with quality assurance and control during product development process.
Execute QC testing to verify test results.
Coordinate QA/QC activities, ensuring quality control in accordance with the requirements of Standard Operating Procedures (SOPs), protocols and product Development specification documents.
Conduct raw materials audits.
Ensure all vendors have been qualified and adhere to vendor qualification standards with the aim of optimal utilization of the reduced testing procedure.
Ensure that the Equipment Calibration Program complies with internal SOP requirements.
Coordinates inter departmental quality activities.
Focus on continuous improvement in all aspects of production work flow based on findings and process observations.
Conduct investigations regarding out of specifications (OOS) results, address and manage deviations related to analytical procedures and provide updates at daily and weekly meetings.
Gather metric information for use in continuous improvement of areas of responsibility.
Establish and implement a KPI structure to ensure optimal test / cost ratio.
• Group Leader (GL) of the Product Development Stability Section.
• Ensure the GLP and GMP in ADL( Analytical Development Laboratory).
• Cheeked by the CCR, CDR, Stability Protocol, Method Validation protocol and Method Validation report of Finished Products.
• Also cheeked by the newly development methods (In-house, BP, USP, Emcure).
• Responsible for the USFDA inquiry related issue.
• Fully responsible for the ANDA project and EMCURE Project.
• Fully responsible for the lunching of New/Exiting products through by DGDA.
• Daily work allocation of Product Development Stability team member.
• Data review of ANDA and Domestic products.
• Monitoring and review the all types documentation of PQ, IQ, OQ of HPLC, Dissolution Tester, IR, UV AAS, HPLC Column.
• Management product development stability samples of Solid Dose, LVP, SVPO, nasal spray and MDIs, verification Finished Products, ANDA, EMCURE projects.
• Always support to Formulation Development(FD), PMD, IMD, TSD, QA, QC, RA and DGDA.
• Administrative support to HRD (KRA-KPA, PMS, Jobs conformation, Requisition, manpower calculation, shifting control).
• Providing technical support to the sales & marketing team through troubleshooting, process engineering, consulting, and coordinating activities.
• Conduct testing and evaluation on competitors’ sample and raw materials as required.
• Responsible for the implementation and maintenance of paint formulation and the quality of paints produced in the factory.
• Carry out In Process check of production lines.
• Ensure quality of the final product of soap.
• Monitor & maintain the subordinates/group members
Analytical Chemistry,
Major Subject: Inorganic, Organic, Environmental ,Physical Chemistry.