Pawan Kumar Singh Email & Phone Number

Aurangabad, Maharashtra, India

Responsible for QA Function

Aurangabad, Maharashtra, India

Responsible for quality function

Daman

 IPQA- Guidance and supervision & Performance management of all IPQA personnel for their routine work. Responsible for batch release as per specification, technical agreement and license. Ensure adequacy of in process samples, finished product samples and review of their analysis report before release of dug products. Responsible to ensure that correct practices are followed at each stage of processing and implementation of their compliance. Responsible for SOP’s and Batch Records review and approval. Quality Management System: Responsible to coordinate as a team leader/team member for handling, investigation & their evaluation of Quality Management System (Change control, deviation, CAPA, laboratory incident, market complaints and continuous process verification). To identify thee needs, organize & Coordination training to IPQA Executives, Production Executives, Stores Executives, Technical Assistants’ and Contract Workmen on SOP’s, Changes in SOP’s, CGMP, CAPA and many more. Quality Risk Management: To coordination for preparation and review of process Risk Assessments, Gap analysis and updation Inspection: Responsible to perform and coordinate self inspection as per schedule and their compliance. Co-ordinate and prepares audit compliance reports for site inspection program any regulatory audits. Ensuring implementation of the proposed corrective and preventive actions for audit findings, market complaints, deviations, risk analysis & non-conformances.  To coordinate or perform the vendor auditing and its evaluation. Validation: To Coordination in execution of validation/ qualification activities. To ensure dispatch of products as per cGMP norms and defined procedures.

Jadcherla,Mb, Andhra Pradesh

 Preparation of process validation protocols and coordinating in execution of validation activities and process validation summary report for the products manufactured for various regulatory markets. Preparation, review, execution and compilation of Installation qualification, operational qualification and performance qualification protocols for manufacturing and packaging equipments equipment/ system validation/ qualification protocols Responsible for co-ordination for internal and external training Conducting training programs and internal audits. Preparation, review, execution and compilation of cleaning Validation control. Coordinate for Markets complaint, Change control, Deviation and Non-conforms.  Enhancement of documentation system. Handling of change control, deviation, Non-conforms, as per quality management procedure. Prepared of annual product quality review for the various products Responsible for Preparation, review co-ordinate the training program and its evaluation of all employees. Issuance and archival of training records. Preparation of job responsibilities, organization charts, employee master list, specimen signs. Preparation, Execution and coordinated in vendor qualification activities.  Preparation of drug license for various products in local FDA and test license for Delhi

Jammu Area, India

 Perform and review day to day activity at shop floor including line clearance BMR review, stage release, inprocess test, sample collection etc. Preparation, Review, Issuance & control of BMRs, BPRs, SOP, Organogram, Employee Master List Specimen Signature and preparation of APR’s Assist with documentation, and other duties as required, during Quality Assurance Audits, to support QA and Regulatory Affairs.  Assist/ perform various type of validation like, Environment Validation, Water System Validation. Handling of change control, deviation, Non-conforms, audits & compliance & Market complaints & Feedback through the quality management procedure.  Perform Review of Microbiological activities.

Faridabad Area, India

 Preparation, Review, Issuance & control of BMRs, BPRs, SOP & Spec, Master Formula, Organogram etc.  Responsible to perform and checked ensuring in-process, environmental & cleaning parameters. Responsible for line clearance, sample collection. Assist/ perform various type of validation like, Environment Validation, Water System Validation, Filling Machine Validation, and Vacuum Sealing Machine Validation. Handling of change control, deviation, Non-conforms, audits & compliance & Market complaints & Feedback through the quality management procedure.  Responsible for the preparation training schedules and Co-ordination for all internal and external training program.  Responsible to prepared batch release note and review of BMR Micro Analysis data & chemical review lab & sterilization chart on daily basis to release the finished product.  Preparation of vendor schedule and Assist / perform supplier and contract manufacturer audits as and when required.

M.Sc, Microbiology

Activities and Societies: Microbiology

M.Ba, Total Quality Management

Activities and Societies: Total quality management

B.Sc, Chemistry

Activities and Societies: Chemistry,Zoology & Botany

Education record