Sr Manager QA
Sovereign pharma (Sister concern of serum institute)
مجموع سنوات الخبرة :13 years, 4 أشهر
Smooth operation of all QA activities and functions on day to day basis
Harmonization and implementation of Quality system at plant level as per the regulatory guidelines.
Gap analysis and implementation of regulatory requirements for QMS, validation and qualification.
Responsible for approval for Site Master File, Validation Master Plan, Annual Product Quality Review Reports, etc
Approval and rejection of Deviations, Batch failure investigations, Change Controls, Product recall, Market complaints etc.
Review and Approval of Internal Audit Report and CAPA.
Compliance of observations of internal and external audit related to Quality management systems and Validation / Qualification
Institution of validation and qualification strategy (cleaning validation, process validation, equipment qualification, HVAC Qualification and Utilities qualification) and its implementation at site for regulatory compliance. Conducting training on quality system, qualification, validation, aseptic process simulation, clean room behaviors etc., Training and development of personnel. Played an leadership role in Quality Management System in site quality operation
Review of all Qualification and validation protocols and reports.
Management and execution of calibration and validation activities by external agencies.
Conducting training on quality system, qualification, validation, aseptic process simulation, clean room behaviors etc.
Responsible for conduct the Quality system review.
o Focus on Quality Management System i.e.
a. Handling of Plant Quality Management System.
b. Site Master File - Review and Control.
c. Handling of Change control, Deviation & CAPA.
d. Handling of Market complaint and Product recall.
e. Review and Compliance of Internal Audit.
f. Annual Product Review
g. Handling of quality tools such as Ishikawa 6Ms/4Ps, FMEA, Why-Why Analysis and Statistical analysis of data through Minitab software.
o Focus on Validation Activities:
a. Validation Master Plan - Review and Control.
b. Equipment / Instrument Qualification and Validation.
c. Area Qualification and Line clearance for aseptic process operation.
d. Water System Qualification and Validation.
e. Aseptic Process Validation by Media Fill Activities.
f. HVAC Qualification and Validation.
g. Temperature mapping study of warehouse.
h. Utility Qualification and Validation such as compressed air, Nitrogen gas and Pure Steam
1) Quality management system
a. Change control system
b. Deviation Management
c. Internal Audit
d. Vendor Audit
e. Market complaint
f. CAPA
g. Failure Investigation
h. Product Recall
2) Qualification and Validation activities
a. Process Validation
b. Cleaning validation
c. Aseptic process simulation
d. Equipment Qualification and Validation
e. Utilities Qualification and Validation.
bachelor of science
Diploma in pharmacy