MANOJ BABU
Wesley Chapel,FL
Summary
QUALITY ASSURANCE & COMPLIANCE MANAGEMENT Extensive pharmaceutical industry experience (over 22 years) focused on the quality of varied pharmaceutical products and all related FDA, EU, GMP and ICH compliance. Specific competencies in: Non-conformance Investigations Staff Management/Training QA Auditing / Reporting SOP Revision/Development Consumer Complaint investigations Supplier Quality Audits/Lead Auditor External Manufacturing Quality Assurance Quality Agreements Supplier Quality Management Process Validations Cleaning Validations Technology Transfer Annual Product Review Batch Record Review/Release Regulatory Inspections New Product Developments Packaging Validations Change Control Management
Overview
29
29
years of professional experience
1
1
Certification
Work History
Quality Account Manager
Johnson and Johnson
03.2012 - Current
- Leads and maintains the quality and compliance relationship with the External Manufacturing (EM) sites
- Leads the qualification for a new EM facility or an existing EM facility in case of changes
- Leads new product developments and Tech Transfer Projects (Manufacturing & Packaging
- Lead audits included PAIs and support BOH inspections
- Facilitates Cleaning Validation Discussions
- Manages Non-Conformance investigations
- Reviews and approves Change Controls
- Participates in complaint investigations and review of resulting investigations and corrective actions
- Negotiates and implements Quality Agreements
- Facilitates Quality Business Review Meetings
- Reviews and approves Process/ Packaging Validation documents such as PDAP,IQ/OQ, PQ, PDR,PPQ and SQP documents
- Reviews and approves Cleaning Validation Documents for tech transfer, new products and base business projects
- Leads risk assessment process and provide data, metrics and provide an opinion on the EM being evaluated
- Participates in Quality audits and ensure that critical and major audit observations are addressed in a timely manner
- Participates in the Disengagement process
- Provides compliance guidance to the EM sites
- Performs general GMP audits, mock PAI and for cause audits
- Reviews and approves APRs
- Performs Quality Risk Assessment
- Supports the supply chain by ensuring that the batches are released to the market in a timely manner.
Coordinator
Merck Sharp Dohme (MSD)
12.2010 - 03.2012
- Developed and implemented Quality Agreements, Supplier Test Qualifications, etc
- Developed appropriate corrective actions in order to support continuous improvements to the EP’s quality systems
- Presented these plans with EPs during the Tier 1 and 2 Quality Meetings and Business Review Meetings
- Reviewed and approved product related change proposals from a quality and GMP stand point
- Managed internal and end customer complaints by ensuring that all justified complaints requiring investigation at the EPs are answered in a timely manner and that the EPs investigation report is appropriate and meeting requirements
- Facilitated the Merck and other Regulatory Agency inspections which included ANVISA, Turkish MOH, KFDA, etc
- At the contractor site
- Define appropriate action plans for improvement and periodically follow-up and communicate action closures
- Act as the Merck representative in the event of an external regulatory audit involving Merck product at the contractor
- Ensured that APRs are timely generated by the contractor for Merck products or generate APR for products when needed and ensure required corrective or preventative actions are defined and implemented in a timely manner
- Reviewed and approved all major and critical deviations generated at the contractor and negotiate any actions required
- If necessary, initiate the “Notification to Management” process and facilitate a proper resolution for the non-conforming
- Periodically assessed the overall quality risk associated with the contractor
- Acted on adverse trends in order to improve contractor quality and compliance performance
- Reviewed batch records and released products
- Reviewed and approve validation reports, IQ/PQ, stability specifications, drug substance specification, developmental protocols from a Quality and GMP stand point
- Supported GMP renewal and new drug application filings.
QA Team Leader
McNeil Consumer Healthcare
02.2005 - 12.2010
- Conducted non-conformance investigations and developed CAPAs
- Reviewed and approved Quality Notifications
- Lead/Conducted Consumer Complaint Investigations
- Supervised QA Specialists and Associates
- Developed SOPs and guidelines to execute new quality programs and systems
- Trained new QA personnel on reviewing batch records, conducting in-process monitoring audits and batch releases
- Revised SOPs to improve compliance and streamline practices / procedures
- Reviewed and approved master batch records
- Provided ongoing compliance support to QA and operations by conducting in-process monitoring and formal audits
- Lead QA Special Projects (Kaizen events and Lean initiatives)
- Supported Contract Quality Operations
- Addressed Internal and FDA audit observations
- Lead internal cGMP audits
- Conducted supplier audits
- Assisted in hosting FDA facility inspections by acting as scribe and/or reviewing documents and identifying and calling operational staff to answer questions as needed
- Reviewed completed batch record, certificate of analysis and release products according to the SOPs and industry practices.
QA Compliance Coordinator
GlaxoSmithKline
06.2004 - 11.2004
- Reviewed complete manufacturing batch documentation prior to release of sterile product, anti-infective and cancer drugs
- Provided technical problem solving and investigation support to quality engineers
- Generated dashboard metrics regarding documentation errors for QA, QC, and operations management review.
Plant Compliance Specialist
McNeil Consumer & Specialty Pharmaceuticals
05.2000 - 04.2004
- QA compliance liaison for solid dose bottling
- Supported GMP compliance by troubleshooting GMP deficiencies, partnered with operations to identify root causes for non-conformances reports, recommended and implemented preventive actions, and developed and presenting GMP training modules
- Provided additional GMP compliance support to the liquids, granulation, compression, coating and printing, gelatin-dipping, and packaging areas
- Reviewed processing, packaging, and contract facility batch records and disposition of in-process, bulk, and finished goods according to cGMPs, and company SOPs
- Developed departmental SOPs and guidelines
- Conducted roving and formal GMP audits.
QA Supervisor
Schein/Watson Pharmaceuticals
08.1996 - 03.2000
- Supervised QA inspectors evaluated and qualified the QA trainers and coordinated personnel
- Motivated and trained personnel on a wide range of responsibilities to elevate employee performance, promote advancement and efficiency
- Managed SOP review and revision
- Performed GMP Investigations
- Performed batch record review, and release of sterile pharmaceuticals
- Coordinated Annual Product Reviews.
QA Inspector
URL Pharma
02.1995 - 08.1996
- Performed in-process and GMP inspections
- Performed batch record reviews
- Inspected and released packaging materials
- Sampled incoming raw materials.
Education
M. A. Organizational Management -
University of Phoenix
01.2002
B.S Pharmacy -
DR MGR Medical University
Madras, India01.1994
Skills
- Demonstrates ability to: excel at execution, collaborate in cross-functional teams, cultivate an assertive front, maintain commercial acumen to effectively work with external companies, and present intercultural skills
- Presents a sense of urgency to complete project goals, investigations, and change controls including all necessary information to make decisions on batch disposal, product commercialization, etc
- Experience in commercial solid and liquid dose manufacturing operations with an in-depth knowledge of global regulatory and compliance requirements
- Maintains ability to adapt, anticipate issues, work under uncertainty, and accommodate flexible work demands
- Has in-depth knowledge and skills in managing CMOs to ensure that commercial drug product operations remain in a complain state, and products meet all required standards and specifications; specifically, managing deviations, change controls, CAPA resolution, and lot disposition
- Working knowledge of Risk Management tools including: FMEA, KT analysis, and 5 Whys
- Experience working with FDA and other regulatory agency personnel during site audits
- Ability to manage QA staff
- Works collaboratively with commercial and development product manufacturing teams, business partners, and CMOs
Certification
ASQ Certified Quality Auditor, 06/2015
Professional Advancement Courses
- CGMP for Production Supervisors-2005
- Human Error Investigations (Talsico) –2008
- Human Error Reduction –Batch records, Forms, Checklists (Talsico)-2008
- Problem Solving and Decision Making ( KT Analysis) -2009
- Yellow Belt and Six Sigma (2011)
- IVT-Validation (2012)
- IVT-Pharmaceutical/Medical Devices Audits and Inspections (2013)
- Cleaning Validations – ISPE (2015)
Awards
- Johnson & Johnson Eagle Award -2013
- Encore Platinum Awards 2013 to 2019
- Johnson & Johnson Standards of Leadership Award -2018
Timeline
Quality Account Manager
Johnson and Johnson
03.2012 - Current
Coordinator
Merck Sharp Dohme (MSD)
12.2010 - 03.2012
QA Team Leader
McNeil Consumer Healthcare
02.2005 - 12.2010
QA Compliance Coordinator
GlaxoSmithKline
06.2004 - 11.2004
Plant Compliance Specialist
McNeil Consumer & Specialty Pharmaceuticals
05.2000 - 04.2004
QA Supervisor
Schein/Watson Pharmaceuticals
08.1996 - 03.2000
QA Inspector
URL Pharma
02.1995 - 08.1996
M. A. Organizational Management -
University of Phoenix
B.S Pharmacy -
DR MGR Medical University