Pradeep Birthare
Indore,India
Summary
Dedicated Senior Quality Management professional with over 30 years of extensive experience in Pharmaceutical industry , out of which over 15 years got Global exposure in various countries including Ireland, Washington, Nigeria, Cameroon and Zambia), have a history of meeting company goals utilizing consistent and organized practices. Skilled in working under pressure and adapting to new situations and challenges to best enhance the organizational brand.
Fully proficient with in-process testing, calibration of instruments, sampling and ensuring observance of end-to-end quality assurance. All-round competencies in quality assurance domain including all fine aspects including but not limited to Qualifications & Validations, Quality Audits, Documentation, Chemical & Instrumental Analysis. Track record in implementing cost saving measures to achieve substantial reduction in terms of budgeted cost.
Introducing an exiting switch and currently offering consultation services to Pharmaceuticals PAN India and looking to expand globally soon.
Overview
25
25
years of professional experience
1
1
Certification
Work History
General Manager Compliance - Consulting
Pentagon Labs Limited
02.2022 - Current
- Monitoring all Quality Management systems to ensure compliance
- To meet requirements of regulatory authorities, company Standard Operating Procedures (SOPs) and external customers, with respect to quality, service, lead time
- Ensuring that all activities are performed in accordance with GMP, and Health and Safety policies
- Responsible for C GLP /C GMP & GWP compliance in the plant as per the current WHO Practice
- Providing direction and guidance to the Quality team
- Reviewing data & give direction to quality personals
- Management of Laboratory Instruments & control
- Self-inspection / regulatory audit & their compliance
- To provide training of plant personnel on department policies, systems and processes
General Manager Quality
VIATRIS (Mylan)
10.2017 - 01.2022
- To ensure it meets business requirements and customer deliverables, as well as ensuring departmental performance against goals
- Implementing and monitoring all Quality Management systems to ensure compliance
- Implementing and maintaining Quality Risk Management system to ensure that risks are adequately controlled in accordance with current requirement
- To meet requirements of regulatory authorities, company Standard Operating Procedures (SOPs) and external customers, with respect to quality, service, lead time
- Ensuring that all activities are performed in accordance with GMP,and Health and Safety policies
- Responsible for C GLP /C GMP & GWP compliance in the plant as per the current regulatory Practice
- Managing all validation activities, including validation strategy and approval of protocols and reports
- Observing and complying with GMP and GDP
- Providing direction and guidance to the Quality team
- Reviewing and approving Technical and Quality Agreements
- Management of Laboratory Instruments & control
- Self-audit / regulatory audit & their compliance
- Overall responsibility of the Plant
- To provide training of plant personnel on department policies, systems and processes
- Audit Exposure: Gazibona, Zamra.
Deputy General Manager Quality
Symbiotec Pharma lab Ltd
02.2012 - 09.2017
- Administer quality control activities and to spearhead quality assurance function with overall responsibility for quality management of company's product range
- Review stability study program status for each product
- Evolving Documentation Systems to meet cGMPs / GLP and Regulatory standards
- Responsible for coordinating, planning, identifying and conducting training on cGMPs, Regulatory, Systems and Documentation Practices, Handling Internal audits of QA /QC / utilities / warehouse / Solvent Recovery plants through structured self audit approach
- Audit compliance & execute audit deliverables
- (regulatory & customer audit) To identify the GMP lapses in laboratory and preparation of proposed CAPA report and implementation
- Handling of Deviation, Change control, OOS chasing and closing in the QC ,QA, Microbiology & Other dept
- Ensure effective budgetary control & cost reduction measures in QA/QC dept
- Successfully headed the Quality control & assurance for the execution of regulatory audits i.e EUGMP, USFDA etc
- Responsible for finished product release Authorization of Corporate SOPs, Quality Manual, VMP, SMF, Validation documents and other Master Documents
- Ensuring effective safety systems are implemented in labs
- Overall responsible for Quality Operations
- Audit Exposure: German Barbarian (EUGMP), USFDA
General Manager Quality
CINPHARM SA (Cameroun)
08.2010 - 12.2011
- Responsible for monitoring the quality of products (sterile & non sterile) manufactured and to assure quality of products in each stage of manufacturing
- Responsible for C GLP /C GMP & GWP compliance in the plant as per the current regulatory Practice
- Closely monitor and to ensure compliance to regulatory requirements (ATR)
- Management of Laboratory Instruments & control
- Calibration of QC /Micro instrument & documentation
- Review the analytical Data
- Self audit / vendor audit & their compliance
- Administer quality control activities and overall responsibility for quality management of company's product range
- Identify shortfalls in awareness/understanding/access of process and practice while providing effective solutions; handling incident and non-conformance reporting
- New product launch, overseas purchase, technology transfer training and development setting up systems and procedures
- Successfully handled the project (QMS) of plant for making it comply to regulatory expectations
- Successfully ensured cordial relations between employees of various levels and built a disciplined team
- Audit Exposure: WHO-Geneva / Local FDA
Sr. Manager Quality
RANBAXY NIGERIA LIMITED
04.2005 - 07.2010
- Technical expertise, leadership to meet specified timelines
- Overall Supervision of Quality Control laboratory
- Ensuring the Qualification, Calibration, Preventive maintenance of QC & Micro Instruments/Equipments
- Successfully analyzed and approved the in-process materials, intermediate and finished product
- Ensured products are stored, distributed and subsequently handled so that quality is maintained throughout shelf life
- Prepared Standard Operating Procedures, calibration of QC Instruments & Equipments and conducting stability studies
- Supported new product launches and Technology transfer projects & GMP assessment at Third parties as per Ranbaxy Policy
- Initiated Audit at third party manufacturing
- Propagated Quality Circle movement and developed quality culture in the work force to achieve quality leadership in the industry
- Formulated plan for reducing rejection and enhancing yield by effective utilization of manpower and taking preventive measures for frequent breakdown of machines
- Vendor Audit & compliance
- Devised effective strategies for control & review of batch records, SOPs & specification and release of RM/PM/In process & finished Products
- Manage and administer people processes including provide training of personnel on company and department policies systems and processes
- Audit Exposure: WHO, NAFDAC
Quality Manager
RANBAXY LABORATORY LIMITED
06.2001 - 03.2005
- Shouldered the responsibility for Documentation and Data control – Review, approval, issue and control of Standard Operating Procedures
- Handling of Deviation, Change control, OOS chasing and closing in the QC and Microbiology
- Initiated the turnaround efforts for ensuring the monitoring of effective implementation of GLP/GMP norms, as per the laid down systems in the Quality Control lab
- Associated closely and supported Product release and troubleshooting quality problems, continuous improvement programs at Third party, establishment and implementation of Quality Assurance and Quality Control systems at contract manufacturers
- Handled product release by review of all documentation relating to the manufacturing, packaging and in- process report of each batch of product before dispatch
- Led efforts in developing & executing best practices & standard operating procedures targeting at organizational excellence
- Ensured instruments are qualified & calibrated in QC & Micro lab
- Responsible for PM of all instrumentation QC / Micro Lab
- Audit Exposure: WHO-Geneva, MCA, MCC
- USFDA.
Quality Control Officer
RANBAXY IRELAND LIMITED
01.1999 - 05.2001
- Drove process standardization by creating and implementing SOPs, resulting in increased efficiency and reduced deviations.
- Evaluated and approved new suppliers based on thorough assessments of their quality management systems, ensuring ongoing reliability in the supply chain.
- Improved product quality by implementing stringent inspection processes and quality control measures.
- Facilitated cross-functional team collaboration, ensuring seamless communication between departments regarding quality matters.
- Oversaw department of 12 by supervising daily operations, providing technical support and coordinating personnel.
- Minimized down time 19% by reducing production rework and recalls.
Education
Master of Science - Medicinal And Pharmaceutical Chemistry
Jiwaji University
Gwalior, MP1985
Bachelor of Science -
Bundelkhand University
Jhansi , UP1981
Skills
- Total Quality Management
- Risk Management
- Project Management
- Business Development
- Budget Allocation and coordination
- Efficient multi-tasker
- Training and Development
- Performance Improvement
- Product Development
- Deadline-oriented
- Risk Mitigation
- Project scope
- Exceptional interpersonal communication
- Change Implementation
- Operations Oversight
- Verbal and written communication
- Problem Resolution
- Inventory Control
- MRP and ERP systems
- Labor Cost Controls
- Analytical Skills
- Cost Reductions
Accomplishments
- I was shortlisted for Project Crusoe, a cost saving project in Ranbaxy in 2001- API & EXCIPIENTS.
- I have completed capacity enhancements project & GMP upgradation for Ranbaxy Nigeria in 2007.
- I have designed and renovated the plant ans system as per the expectation of regulatory bodies (NAFDAC)
- Plant upgradation as per the WHO requirements in CINPHARM at Cameroun.
- Audit Exposures - WHO, MCA, MCC.USFDA, Irish Medical Board, NAFDAC, EUGMP, local FDA, etc.
Languages
English
Native or Bilingual
Hindi
Native or Bilingual
French
Limited Working
Certification
- Twenty five days training in Pune, conducted by Lab India Limited with focus on Chromatography.
- Six days training on HPLC analysis & Troubleshooting by Waters India.
- One day workshop attended for "Data Integrity and GMP documentation" by French Consultants.
- Three days training course on CGMP at Abuja, Nigeria.
- One week training on FTNIR analysis & Validation by FOSS NIR Systems at Maryland, USA
Timeline
General Manager Compliance - Consulting
Pentagon Labs Limited
02.2022 - Current
General Manager Quality
VIATRIS (Mylan)
10.2017 - 01.2022
Deputy General Manager Quality
Symbiotec Pharma lab Ltd
02.2012 - 09.2017
General Manager Quality
CINPHARM SA (Cameroun)
08.2010 - 12.2011
Sr. Manager Quality
RANBAXY NIGERIA LIMITED
04.2005 - 07.2010
Quality Manager
RANBAXY LABORATORY LIMITED
06.2001 - 03.2005
Quality Control Officer
RANBAXY IRELAND LIMITED
01.1999 - 05.2001
Master of Science - Medicinal And Pharmaceutical Chemistry
Jiwaji University
Bachelor of Science -
Bundelkhand University
Similar Profiles
Amol BisaryaAmol Bisarya
Enterprise Account Manager at Pentagon System and Services Private LimitedEnterprise Account Manager at Pentagon System and Services Private Limited
AKSHAY SAWANTAKSHAY SAWANT
IT Executive – IS&T Support at Pentagon System & Services Private LimitedIT Executive – IS&T Support at Pentagon System & Services Private Limited
Manjunath BGManjunath BG
Business Development Executive at Pentagon Space Private LimitedBusiness Development Executive at Pentagon Space Private Limited
Amit TiwariAmit Tiwari
Assistant Manager at ViatrisAssistant Manager at Viatris
Sanskar PatidarSanskar Patidar
Legal intern at Jus CorpusLegal intern at Jus Corpus