R. Ramesh
Hyderabad
Summary
Masters in pharmacy with 13.6 years of Quality assurance experience in the field of Sterile Pharmaceutical and Biologics manufacturing (Vaccines). Managing a team with proficient in implementing the Quality management systems, Vendor / Supplier management, Audit & compliance and In process activities. Good experience in handling of regulatory audits.
Overview
14
14
years of professional experience
Work History
Deputy Manager
Biological E. Ltd
Hyderabad
12.2021 - Current
- Corporate Quality Audits, Vendor /Supplier Management & External Quality operations:
- Managing a team of 3 staff, ensuring the supplier quality activities and priorities are managed based on the business needs
- Setting the goals for the team as per the KPIs, monitoring and supporting the team to achieve them according to the timelines
- Planning and Execution of Vendor qualification and life cycle management of suppliers, service providers as per the regulatory requirements
- Ensure the Qualification of raw material, packaging material, critical consumable Vendors/ suppliers and third-party testing laboratories
- Effective coordination with various stake holders and cross functional teams for collaboration in closure of tasks identified during the Vendor / Supplier qualification
- Preparation and review of risk assessment as part of supplier evaluations
- Preparation of Vendor/Supplier audit schedules, Planning, Participate and conducting of domestic and international supplier onsite audits
- Maintain and follow up, tracking and on time closure of the CAPA actions related to supplier audit observations
- Preparation of audit summary report and vendor qualification reports
- Preparation and approval of master creations and approved vendor list
- Handling of periodic performance review of suppliers and quality technical agreements review
- Preparation of quality metrics for management review meetings
- Handling of vendor complaints and review of investigation along with CAPA plan for closure
- Handling of vendor change notifications and evaluate the quality impact on the finished product and their documentation
- Control of material management in SAP in terms of Quality
- Handling of key electronic quality management system (EQMS) records through Trackwise
- Reviewing and assessment of change controls & deviations related initiated by various cross functional stake holders
- Planning and execution of Corporate Quality Audits (self-inspections/ internal audits), vendor audits, unscheduled compliance inspections
- Prepare, Review and approval of various SOP’s and GMP/GDP documentation in compliance with corporate and regulatory requirements
Deputy Manager
Gland Pharma Ltd
Hyderabad
11.2020 - 12.2021
- Handling of External Audits like Regulatory, Customer, Supplier and Consultant Audits
- External Audit compliance report preparation and follow-up the action items closure
- Internal Audit report and compliance report preparation
- Verification of CAPA effectiveness monitoring
- Prepare, review and approve SOP’s to alignment with current Good Manufacturing Practices.
Asst. Manager
Aspiro Pharma Ltd (Hetero Group)
Hyderabad
12.2016 - 10.2020
- Handling of External Audits like Regulatory, Customer, Supplier and Consultant Audits
- External Audit compliance report preparation and follow-up the action items closure
- Internal Audit report and compliance report preparation
- Verification of CAPA effectiveness monitoring
- Prepare, review and approve SOP’s to alignment with current Good Manufacturing Practices.
Executive
Biological E. Ltd
Hyderabad
11.2012 - 11.2015
- In process QA and Batch record review and release activities
Officer
Micro labs Ltd
Bangalore
12.2011 - 11.2012
- In process QA and Batch record review and release activities
QA Chemist
Gland Pharma Ltd
Hyderabad
08.2010 - 11.2011
- In process QA and Batch record review and release activities
Education
Masters in pharmacy -
Vikas college of pharmacy
Bachelor of pharmacy -
S.R.R College of Pharmaceutical sciences
Skills
- Supplier Quality
- Vendor complaints, Notifications
- Audit management system
- Internal & External Audits
- Vendor/Supplier Audits
- Deviation, Change Control, CAPA, Quality Risk Management
- In-Process Quality Assurance
- Batch record review and release
- MS Office
- SAP, DMS, Track wise software
- Team management, Problem solving skills, Multi task handling
- Training skills
Accomplishments
- Successfully handled various Regulatory Audits like USFDA, WHO-Geneva, ANVISA, INVIMA, UKRAINE, Kenya, PERU, SAHPRA, Malaysia audits.
- Successfully handled various international and domestic Supplier/ Vendor Audits.
- Qualified with ISO 9001:2015 Lead Auditor certification.
Disclaimer
I hereby declare that the above-mentioned are true and correct to the best of my knowledge.
Languages
- English
- Telugu
- Hindi
Personal Information
- Father's Name: Late Mr. R.Nagendram
- Date of Birth: 08/26/88
- Gender: Male
- Nationality: Indian
- Marital Status: Married
Timeline
Deputy Manager
Biological E. Ltd
12.2021 - Current
Deputy Manager
Gland Pharma Ltd
11.2020 - 12.2021
Asst. Manager
Aspiro Pharma Ltd (Hetero Group)
12.2016 - 10.2020
Executive
Biological E. Ltd
11.2012 - 11.2015
Officer
Micro labs Ltd
12.2011 - 11.2012
QA Chemist
Gland Pharma Ltd
08.2010 - 11.2011
Masters in pharmacy -
Vikas college of pharmacy
Bachelor of pharmacy -
S.R.R College of Pharmaceutical sciences
Similar Profiles
Anuttam KuilaAnuttam Kuila
Executive - Production at Biological E. LtdExecutive - Production at Biological E. Ltd
Sean QuigleySean Quigley
Undergraduate Research Assistant at UCSC Physical and Biological SciencesUndergraduate Research Assistant at UCSC Physical and Biological Sciences
Noelia Do CantoNoelia Do Canto
Laboratory Research Assistant at Clemente Estable Biological Research Institute- Department of Molecular and Cellular NeurophysiologyLaboratory Research Assistant at Clemente Estable Biological Research Institute- Department of Molecular and Cellular Neurophysiology
Suresh BhumireddySuresh Bhumireddy
Technical Specialist at Bosch Global Software TechnologiesTechnical Specialist at Bosch Global Software Technologies
Sameer TelikicherlaSameer Telikicherla
PAM Consultant at Capgemini India Pvt Ltd.PAM Consultant at Capgemini India Pvt Ltd.