Pradip Kumar Email & Phone Number

Andhra Pradesh, India

Visakhapatnam, Andhra Pradesh, India

• Responsible for Quality Assurance and Quality Control activities of the firm’s API plants located in India (3 Plants), Formulation plant (1 each) based at India & Bremer (Warburg, Germany) and R & D center based at Visakhapatnam and Mangalore. • Responsible for Corporate Quality activities including Audit & Compliance, Harmonization, Vendor Quality Management and handling all its Contract Manufacturing sites.• Responsible for all the site’s anytime audit readiness and maintaining compliance culture.• Review and finalizing response to various regulatory and customer audit observations.• Responsible for implementation of quality culture.• Strong collaboration with cross functional team for developing quality commitment and mindset.• Drive corporate quality plan based on site quality improvement plans and audit findings.• Review of Quality Management meetings at Corporate level.• Lead - Continuous Improvement initiatives at organization level.• Strong collaboration with customers in quality matters.• Monitoring various compliance metrics for various sites and CMOs and presentation to Board from time to time.• Responsible for reduction in OPEX of all site quality control laboratory; monitoring of all site quality control laboratory plan vs. actual

Vishakhapatnam Area, India

• Responsible for Corporate and site quality assurance activities.• Ensuring the site for anytime audit readiness. Facing, responding and tracking customer / regulatory audits.• Implemented transparent pharmaceutical quality system across organization in a young vibrant pharmaceutical company.• Preparation and drive corporate quality plan based on site quality improvement plans and audit findings.• Review and approval of quality technical agreement (QTA) for all service providers.• Responsible for handling of customer complaints, product recall and return by ensuring proper investigation and CAPAs.• Responsible for successful quality audits and reduction in customer complaints YoY.• Ensuring all the investigations pertaining to deviations, incidents, OOS & OOT are properly investigated and suitable CAPA proposed.• Ensuring Preventive Maintenance, Calibration, Training and Internal Audit are done in accordance with the established schedule.• Ensuring Quality Management Review is conducted in accordance with the established frequency.• Ensuring all input materials and service agencies are qualified and are maintained in qualified state.• Maintain the quality metrics for the site.• Lead Auditor – Internal and external audits.• Certified Trainer – GMP refresher training.• Lead - Continuous improvement initiatives.• Leading a team by coaching, mentoring & reviewing to execute the above activities

Vishakhapatnam Area, India

• • QA In charge – Quality System implementation and audit management.• Ensured the site ready for anytime audit readiness. Facing, responding and tracking customer / regulatory audits.• Team Lead - Engineering Assurance (CAPEX projects, qualification, maintenance & calibration, computer system validation & electronic data management).• Team Lead – New products handling from technology transfer to QA Release. • Team Lead - Vendor Qualification.• Team Lead – Validation (Process and cleaning method validation).• Team Lead – Analytical Assurance including analytical method validation.• Validated complex Integrated Process Automation System which includes PLC-DCS-MES-SAP. • Implemented Electronic BPR and review by exception mechanism.• Lead Investigator – Incidents, deviations, OOS, OOT and CAPA.• Lead Auditor – Internal and external audits.• Certified Trainer – GMP refresher training and on-the job training.• Active participation in continuous improvement initiatives at organization level.• Led a team by mentoring, guiding & reviewing to execute the above activities

Durban, Kwazulu-Natal, South Africa

• Team Lead – Engineering Assurance (CAPEX projects, qualification, maintenance & calibration, computer system validation & electronic data management).• Simplified Qualification approach and documentation by implementing risk-based qualification approach based on ISPE model.• Subject Matter Expert in various regulatory audits.• Certified Trainer for cGMP trainings

Bangalore Urban, Karnataka, India

- Handled shift manufacturing and packing activities.- Product planning – monthly & yearly tracking of the plan vs. actual.- Shift manpower planning.- BMR & BPR preparation.- Filling up of batch documentation during execution.- Review of BMR & BPR after execution.

Chennai, Tamil Nadu, India

- Handled shift manufacturing and packing activities.- Product planning – monthly & yearly tracking of the plan vs. actual.- Shift manpower planning.- BMR & BPR preparation.- Filling up of batch documentation during execution.- Review of BMR & BPR after execution.

Chennai, Tamil Nadu, India

- Handled shift manufacturing and packing activities.- Product planning – monthly & yearly tracking of the plan vs. actual.- Shift manpower planning.- BMR & BPR preparation.- Filling up of batch documentation during execution.- Review of BMR & BPR after execution

Six Sigma, Green Belt

Master Of Business Administration (Mba), Operations Management

Activities and Societies: Project in Operations Research

B.Sc, M. Sc, Biochemistry, I

Activities and Societies: CHAMPION - BIOCHEMISTRY UNIONB.S c - Biochemistry; M. Sc Biochemistry

Lean Six Sigma Black Belt, Six Sigma Body Of Knowledge