Chaitanya Krishna
Manager
Hyderabad
Summary
Seasoned Compliance Manager with a proven track record at PharmSol India Pvt. Ltd, specializing in regulatory expertise and ethical leadership of 12 years experience. Excelled in vendor qualification, audit management, and compliance monitoring, ensuring EU GMP standards. Demonstrated success in enhancing supplier performance and implementing robust training programs.
Overview
12
12
years of professional experience
Work History
Manager - Compliance
PharmSol India Pvt. Ltd
Hyderabad
03.2024 - Current
- Vendor qualification of APIs, Key Starting materials, Intermediates, Excipients, Raw materials and packing materials as per the client requirements
- Performing site audits to comply as per EU GMP requirements
- Execution of Gap assessment audits, Mock audits & QP audits
- Preparation of audit reports & review of compliance status and certify the sites readiness to meet as per EU regulatory requirements
Asst. Manager CQA
Granules India Limited
Hyderabad
12.2020 - 03.2024
- New and alternate vendor qualification for APIs, Key Starting materials, Intermediates, Excipients, Raw materials and packing materials
- Scheduling and auditing vendors for APIs, KSM's, Intermediates, Excipients, Raw materials and packing materials
- Handling of vendor complaints
- Evaluation of vendor with vital declarations and annual assessment of approved vendor
- Executing agreement with vendors
- Customer support by providing GMP Questionnaire, agreements and product based declarations
- Internal compliance assessment audits for all granules sites
- Handling of Quality Management Systems (Change controls, Deviation, CAPA, and Internal Audits)
- Auditing the Facility - Execution as per plan of audits, Preparation of Agenda, opening meeting, auditing the system, sharing the observations in closing meeting and preparation of audit report
- Discussion with the auditee team on response provided to complies with the regulatory requirements
- Review of provided CAPA against the observation to avoid further reoccurrence
- Audit CAPA tracking as per audit response
- Effectiveness monitoring of the proposed CAPA in the forthcoming audits for its implementation
- Compliance check for regulatory audit observation at site, at organization level or 483 of different organizations
Sr. Executive QA
Natco Pharma Limited
Hyderabad
10.2016 - 11.2020
- Line Clearance in core areas (Dispensing, Granulation, Compression, Coating and Packing)
- In process checks during shop floor activities
- Sampling of in process, finished product and sampling according to approved procedures
- Review of Executed batch manufacturing and packing record
- Review of master batch documents and protocols
- Responsible for Handling of validation activities (process validation and revalidation)
- Responsible for Preparation, Training, Periodic review, Revision of SOPs
- Planning, coordination and conducting training program on guidelines as well as on SOPs
- Monitoring cGMP and SOP adherence in all the stages of production activities
Executive -QA
Granules India Limited
Hyderabad
06.2015 - 10.2016
- Executed IPQA and line clearance activities throughout batch manufacturing stages.
- Conducted in-process checks in manufacturing and packing areas for solid dosage forms.
- Monitored and ensured real-time review of batch manufacturing and packing documents.
- Approved and issued BPR/BMR records via AmpelogicBIMS system.
- Performed in-process control tests, sampling during validations, and cleaning validation procedures.
- Handled change controls and deviations, including risk assessments and investigation reports.
- Investigated Out of Specification (OOS) and Out of Trend (OOT) results promptly.
- Ensured adherence to cGMP activities and compliance with established procedures.
Jr. Executive-QA
Globion India private Limited
Hyderabad
06.2013 - 05.2015
- Handling of training and documentation activities
- Scheduling training sessions as per department training matrix
- Preparation issuance and review of SOPs and formats
- Review of process validations and equipment qualifications
- Review of preventive maintenance and calibration schedules for process equipment's
- Review of process logbooks, and calibration logbook for process equipment's
- Online review of executed batch records
Education
Master of Science - Pharmaceutics
SRM University
Chennai, IndiaMaster of Science - Patent Laws
Nalsar Law University
Hyderabad, IndiaSkills
- Compliance monitoring
- Regulatory expertise
- Ethical leadership
- Audit management
- Investigative skills
- Document reviews
- Vendor / supplier performance management
- Technical compliance
- Training and education
Languages
- English
- Telugu
- Tamil
Publications
- Formulation & evaluation of naproxen eudragit RS 100 nanosuspension using 32 Factorial Designs in International Journal of Pharmacy & Pharmaceutical Science.
- Formulation & evaluation of Modafinil fast dissolving tablets by sublimation techniques in Journal of chemical & Pharmaceutical Science.
Disclaimer
I vouch the authenticity of aforementioned information.
Personal Information
- Date of Birth: 07/17/90
- Gender: Male
- Nationality: Indian
- Marital Status: Married
Timeline
Manager - Compliance
PharmSol India Pvt. Ltd
03.2024 - Current
Asst. Manager CQA
Granules India Limited
12.2020 - 03.2024
Sr. Executive QA
Natco Pharma Limited
10.2016 - 11.2020
Executive -QA
Granules India Limited
06.2015 - 10.2016
Jr. Executive-QA
Globion India private Limited
06.2013 - 05.2015
Master of Science - Pharmaceutics
SRM University
Master of Science - Patent Laws
Nalsar Law University
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