A Prashanth Reddy
Hyderabad
Summary
- Over 13+ years’ Experience in Pharmaceutical Quality Systems: - Expertise in Leading a QA organization & Quality Projects in collaboration with business partners and other quality group to ensure health authority and meeting regulatory requirements.
- Experienced leader with strong focus on team collaboration and delivering results. Adept at managing operations, driving process improvements, and fostering positive work environment.
- Sound Experience in Quality Operations review & coordination’s of various Dosage Forms like OSD, SSD & Oral Liquids developments and validations as per US/Health Canada & other Regulatory market requirements.
- Implementation of Quality plan & Support inspection readiness activities, including in participation in audits and management follow-up. Ensuring timely escalation of deviations/Incidents/complaints and provide quality oversight for incidents/deviations including robust investigations & root cause analysis.
Overview
14
14
years of professional experience
Work History
Dept. Manager in Quality Assurance
Jamp Pharma Group
03.2021 - Current
- Quality Lead in Pharmaceutical data review & compliance review of various Dosage form (Solids, Liquids, Semisolid's DF).
- Work closely with all relevant key collaborators for the end-to-end process and ensure compliance to GMP/GDP.
- Site Qualifications & Product Validations review,
- Quality Risk Assessment, Technology transfer doc review, QMS compliance, Overall Audits coordination & response support and CSV implementation.
- Technology Transfer Review, Audit coordination and support.
- Be the contact person between customers and manufacturing sites on audits, serious findings, root causes and CAPAs where needed
- Provide support to the Vendors/supplier periodic monitoring oversight activities.
- Support in tactical activities related to internal/external audits and inspections.
- Perform routine quality assessments and provide assessments of changes that impact master data.
- Take part in operational improvement initiatives, programs, and projects.
- Run training sessions/ workshops for enhancing risk awareness in handling the Product/Process Quality.
- Develop solutions that are thorough, practical, and consistent with functional objectives.
Quality Assurance executive
Laurus Labs Limited
12.2016 - 02.2021
- Responsible in doc review of Formulation development doc (MFR/MPR/PDR etc.) including Pilot-Bio line clearance, cleaning validations & Technology Transfer doc(R&D-site-Mfg.).
- Labeling-Artworks review (Including Printed packaging components)
- Product Development Report & Validation report Review.
- Quality representative to manage regular Quality Reviews with key customers/cross function teams.
- Monitors and reports on progress of the project to Project Lead- prepares status reports with project progress and presentation for senior management; ensures project documents are complete, current, and stored appropriately -Reporting of technical complaints / Issues to the Management.
Quality Assurance Officer
S.M Labs Private Limited
06.2012 - 12.2016
- Review & Approval of SOPs QMS elements like change control, CAPA, deviation, customer complaints, customer feedback, audit nonconformities.
- Review of calibration reports, Preventive maintenance reports, training records, instrument equipment qualification records.
- Investigations & Root Cause Analysis.
- Prepare and present reports on investigation outcomes and CAPA effectiveness to senior management.
- Annual Product quality review.
Jr Asst in Formulation Research & Development
RaChem Pharma Ltd
03.2011 - 02.2012
- Company Overview: (Micro Labs)
- Galantamine ER Pellets for Euro Market
- (Micro Labs)
Education
M.Pharmacy - Pharmaceutics
SASTRA University
Thanjavur, Tamilnadu01.2012
B.Pharmacy -
Bharat Institute of Pharmacy
Mangalpally-HYD, HYD01.2010
Skills
- EQMS (Caliber)/ZenQMS
- Empower3/Chromeleon-73 (CDS)
- Ample Logic-Training (LMS)
- Windows
- Certified ISO9001 and ISO15378 internal auditor
Corejobresponsibilities
- As a QA Lead expert in data review & support in developing various Dosage forms Oral Solids, Liquids, Semisolids for US, Europe & domestic Market.
- Responsible for Review of All Formulations & TT Documents (MFR, MPR, PDS), PEP/PER, PDR, Sampling Plan, Stability Study plan & Hold time Study protocols etc.
- Sound knowledge in Review of Equipment qualifications, AHU Calibrations, Validation activities. Knowledge in CAPA/Six sigma.
- Responsible for the Review of All Printed packaging Art works (Carton, Leaf lets, Foils & Self-Adhesive Labels, shade cards etc. as per Market requirements).
- Handling of Quality management systems like Change controls, Deviations & CAPA during product development & validations, technical complaints and commercial activities.
- Conducting & participation in Internal and external audit (WHO/USFDA support) and provide necessary training coordination (LMS) & issuance - control of GMP documents.
Analyticalsupportexperience
- Expert in Reviewing & finalization of specifications. Lab Instrument qualifications.
- Analytical Method validations Protocols & reports review against raw data/ electronic data.
- OOS, Batch Release review knowledge against Spec & STP (Inline compendial/Inhouse).
Disclaimer
I hereby declare that all information mentioned above is true and correct to the best of my knowledge and belief.
Personal Information
- Available: Three Month from offer confirmation
- Father's Name: A. Narsimha Reddy
- Date of Birth: 10/20/86
- Gender: Male
- Marital Status: Married
Languages
English
Advanced (C1)
Hindi
Intermediate (B1)
Telugu
Bilingual or Proficient (C2)
Timeline
Dept. Manager in Quality Assurance
Jamp Pharma Group
03.2021 - Current
Quality Assurance executive
Laurus Labs Limited
12.2016 - 02.2021
Quality Assurance Officer
S.M Labs Private Limited
06.2012 - 12.2016
Jr Asst in Formulation Research & Development
RaChem Pharma Ltd
03.2011 - 02.2012
B.Pharmacy -
Bharat Institute of Pharmacy
M.Pharmacy - Pharmaceutics
SASTRA University
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