Expert Details

Expert in Product Development, Quality Assurance, GMP Audits, Qualifications, Troubleshooting, Pharmaceutical, Nutraceutical, Production Issues, GMP Compliance, Pharmaceutical Dosage Forms, Quality Control

Expert ID: 726302 India

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Expert has more than 24 years of experience Internationally (New Zealand; Australia; Oman, and India) in pharmaceutical formulation plants, Product Development; Analytical development; Scale-up, Technology transfer; Manufacturing, Quality Assurance; quality control (testing and releasing); Lead regulatory audits and meet the compliance.

Expert experienced in developing, manufacturing, and cGMP compliance of pharmaceutical dosage forms to various markets like US-FDA, UK-MHRA, TGA, ANVISA, RVO& BSG-Germany, MOH-OMAN, GCC-GULF, etc. markets from conception through to product release. Expert excellent knowledge of various kinds of like SOLID DOSAGE FORMS (TABLETS-IR, ER, DR, SOFT GELATIN CAPSULES & HARD GELATIN CAPSULES), LIQUIDS (SOLUTIONS, SUSPENSIONS, and EMULSIONS), INJECTABLES & TOPICAL (CREAMS/OINTMENTS & LOTIONS). In addition, he had good experience in troubleshooting and process improvement.

Expert experience was R&D (Formulation Development), Technology transfer; Operations (Commercial Manufacturing), and cGMP compliance (Quality Assurance) of pharmaceutical dosage forms to various markets like US-FDA; UK-MHRA, TGA, ANVISA, RVO& BSG-Germany, MOH-OMAN, GCC-GULF, etc. markets from conception through to product release. Experienced in Quality Assurance as Head position, faced all major regulatory audits and successfully lead the TEAM for USFDAs / UK-MHRAs / TGA/ EU- Germany / SAPHRA (MCC) / ANVISA / MOH-Oman / SFDA / & GCC- central etc.

Expert experienced in the qualification of pharmaceutical plants and equipment to meet regulatory requirements. Pre Audit preparation, back-end support during Regulatory/ Customer audits, Audit compliance & CAPA closer.

Education

Year Degree Subject Institution
Year: 2000 Degree: Ph.D. Subject: Pharmaceutical Technology Institution: Andhra University, India
Year: 1995 Degree: M. Pharm Subject: Pharmaceutical Technology Institution: Andhra University, India
Year: 1993 Degree: B. Pharm Subject: Pharmaceutical Sciences Institution: Andhra University, India

Work History

Years Employer Title Department
Years: 2019 to 2021 Employer: Sarvotham Care Ltd; INDIA Title: COO Department: Management
Responsibilities:
 Responsible for Leadership Management to oversee the day-to-day administrative and operational functions of firm's Research and Development; Quality Assurance; Plant Operations at various locations; Purchase; Business Development & HR
 Design and implement business strategies, plans, and procedures.
 Set comprehensive goals for performance and growth.
 Establish policies that promote company culture and vision.
 Lead employees to encourage maximum performance and dedication.
 Participate in expansion activities (investments, acquisitions, corporate alliances, etc).
 Manage relationships with partners/vendors.
 Review & Monitor all New Product Development activities in Formulation R&D with the concerned team leaders to see the progress and provide the technical advice (Guidance) to meet the timelines

Attainments:
 Streamlined the departments to meet organizational goals (turned the organization to profits from Losses).
 Tie-up with new customers like P&G, Expert, GSK, ICM(Singapore), Marico and HUL, etc.
 Successfully developed and delivered the new products as per committed timelines.
 Streamlined the procedures and practices in GMP areas and completed Major audits.
 Improved the operational efficiencies in all manufacturing locations for better productivity.
Years Employer Title Department
Years: 2017 to 2018 Employer: AIZANt Drug Research Solutions; INDIA Title: Associate Vice President Department: QA ;& QC
Responsibilities:
 Review & Monitor all New Product Development activities in Formulation R&D with the concerned team leaders to see the progress and provide the technical advice (Guidance) to meet the timelines
 Responsible for overall operational management and supervision of QC department and lead all Regulatory/customers.
 Monitoring of Plant QA systems
 Completed 2 USFDA, 1 EU (Malta), and 1 ANVISA

Attainments:
 Successfully developed and delivered the new products as per committed timelines.
 Streamlined the procedures and practices in GMP areas
 Completed major regulatory audits.
Years Employer Title Department
Years: 2010 to 2017 Employer: OMAN Pharmaceuticals Co LLC; OMAN Title: Head - Quality Assurance and technical Department: Quality Assurance; R&D and Plant Operations
Responsibilities:
 Spearheading end-to-end execution of Research & Development projects, involving initiation, multi-step development, scale-up, and commercialization.
 Directing the entire Quality Assurance, Quality Control, and Analytical Method Validations Teams of the organization and supervising all regulatory audits.
 Assessing requirement and feasibility of research projects involving interface with top management; communicated with the customers to identify their current and future requirements.
 Creating lab strategy and proposed disruptive innovations for the product category; designed robust platforms that can be cascaded into winning formulas matching the defined performance objectives.
 Developing descriptions for the examinations, procedures, research methods, and services designed for the formulation products; sanctioned QA specifications for the formulation products.
 Monitoring scale-up formulations and transferred technology to design dept.; performed process validation of newly developed products & actions to be taken for inconsistent results.
 Providing troubleshooting support in case of complex problems in order to ensure that robust, stable & the scalable formulation is developed.
 Drafted scientific communication describing the technological positioning and performance of the products.
 Working in close coordination with cross-functional departments such as Purchase, Plant, QA & QC and Customer Service.
 Developing strategic partnerships by negotiating with customers (Contract Givers) to offer contract development and manufacturing services of finished dosage forms and also dealing for contract manufacturing services for their site transfer/ Technology transfer products for US and Europe markets.

Attainments:
 Managed a team of R&D Scientists for product development from conception through stability studies for US-FDA; UK-MHRA, TGA, RVO & BSG-Germany, MOH-Oman, and GCC-Gulf.
 Directed Compliance Team to ensure quality in Research & Development, Production and Quality Control & Distribution of OPP Pharmaceutical products.
 Conducted lead regulatory/ customer audits in the plant and managed overall quality.
 Led a team to ensure that products manufactured are tested and distributed according to Current Good Manufacturing Practices (cGMP), Good Laboratory Practice (GLP), and Regulatory compliances.
 Formulated & executed/ensured compliance to quality, validation system & analytical assurance.
 Participated in regulatory and customer audits.
Years Employer Title Department
Years: 2005 to 2010 Employer: LIPA PHarmaceuticals; AUSTRALIA Title: Snr. Principal R&D Scientist Department: R&D; and QA
Responsibilities:
1. Development of generic products for US companies like ENDO Pharmaceuticals, IMPAX, etc.
2. Responsible for developing various kinds of dosage forms like TABLETS (IR & ER), capsule (HARD & SOFTGEL), LIQUIDS; CREAMS/OINTMENTS from conception through stability trial, clinical studies, validation, final manufacture, registration, and release for non-regulated and regulated markets like TGA, MEDSAFE & US-FDA, etc
3. Technical Support to production
4. Lead the R&D group and coordinates with Regulatory, Clinical, Marketing, and Manufacturing teams.
5. Creating lab strategy and proposed disruptive innovations for the product category; designed robust platforms cascaded into winning formulas matching the defined performance objectives.
6. Developing descriptions for the examinations, procedures, research methods, and services designed for the formulation products; sanctioned QA specifications for the formulation products.
7. Monitoring scale-up formulations and transferred technology to design dept.; performed process validation of newly developed products & actions to be taken for inconsistent results.
8. Providing troubleshooting support in case of complex problems to develop robust, stable & the scalable formulation is developed.
9. Monitoring GMP compliance and Plant quality systems
Years Employer Title Department
Years: 2002 to 2005 Employer: Ancare NZ Ltd; NEW ZEALAND Title: R&D Scientist Department: R&D
Responsibilities:
1. Developed Pharmaceutical products for USA, Australia, and New Zealand Markets
2. Project planning, development, and management disciplines and reporting
3. Developed new technologies for kept incompatible drugs in single unit dosage forms and patent.
5. Development of bioequivalent generic products to seek USFDA approval.
6. Involved in many cost reduction projects, which are ongoing production batches.
7. Solved some of the problems in ongoing production batches in injectables, liquids, and semi-solid dosage forms.
Years Employer Title Department
Years: 2002 to 2003 Employer: University of Auckland, Auckland, NEW ZEALAND Title: Department: School of Pharmacy
Responsibilities:
1. Given the support to establish the newly established School of Pharmacy Department.
Developed lipid-based drug delivery systems for poorly soluble systems.
2. Evaluated the new excipient for the controlled release dosage form and applied for the patent.
3. Performing research and development, which aims to present solutions to NZ companies incorporating recent advances in science and technology.
Years Employer Title Department
Years: 2001 to 2002 Employer: Title: Research & Development Executive Department:
Responsibilities:
1. Development of bioequivalent ANDA products to seek USFDA approval under Para 1, 2, 3 & 4 filings.
2. Developed delayed-release formulation for rifampicin.
3. Prepared oral dosage forms like tablets, liquids, injectables, and ointments.
4. Involved in many cost reduction projects, which are ongoing in production.
5. Solved some of the problems, which occurred in ongoing production batches.
Years Employer Title Department
Years: 2001 to 2001 Employer: Title: Research & Development Executive Department:
Responsibilities:
1. Developed floatable drug delivery systems for ciprofloxacin, Amoxycillin.
2. Handled various granulation techniques (Aqueous, Nonaqueous, and melt) for oral controlled and immediate-release products. Prepared oral dosage forms like tablets, capsules, liquids, and ointments.
3. Involved in many cost reduction projects, which are ongoing in production.
4. Solved some of the problems, which occurred in ongoing production batches.
Years Employer Title Department
Years: 1996 to 1998 Employer: NET Pharmacy College, Raichur, INDIA Title: Department:
Responsibilities:
1. Taught a group of Pharmaceutics subjects to undergraduate students.
2. Consultation with the pharmaceutical companies.
Years Employer Title Department
Years: 1996 to 2000 Employer: Andhra University Title: Senior Research Fellow (CSIR) Department: Pharmaceutical Technology
Responsibilities:
Did the research work on Noval Drug delivery systems
Technical support is given to local Pharmaceutical Companies

International Experience

Years Country / Region Summary
Years: 2017 to Present Country / Region: INDIA Summary: Heading- R&D; Quality Assurance ad Operations; Regulatory/ Customer Audits; GMP Compliance
Years: 2010 to 2017 Country / Region: OMAN Summary: Heading- R&D; Quality Assurance ad Operations; Regulatory/ Customer Audits; GMP Compliance
Years: 2005 to 2010 Country / Region: AUSTRALIA Summary: Development of various types of dosage forms from conception through to stability trail, clinical studies, validation, final manufacture, registration, and release with many years in humans and veterinary pharmaceuticals for non-regulated and regulated markets like TGA, MEDSAFE and US-FDA etc. His expertise include supervision of R&D team and coordination with marketing, regulatory affairs, clinical, quality assurance and production departments and he has very good knowledge in formulation improvement and process quality improvement. He has much knowledge on different kinds of dosage forms like SOLID DOSAGE FORMS (TABLETS, HARD & SOFT GELATIN CAPSULES), INJECTABLES, OINTMENTS/ CREAMS, TRANS DERMAL DRUG DELIVER SYSTEMS AND LIQUID DOSAGE FORMS. Expertise on development of NDDS products and many years of experience in PATENT writing and analysis.
Years: 2002 to 2005 Country / Region: NEW ZEALAND Summary: Development of various kinds of dosage forms in veterinary pharmaceuticals.

Career Accomplishments

Associations / Societies
Conferences Attended As Guest Speaker

International Conference on “Current Status and Future Perspective in Pharmaceutical Sciences”: Aug 19-20, 2011, Bangalore, India
International Conference on “Updates on Protein Drug Discovery, Formulation and Production Challenges”, October 28-29, 2011 in Tirupati, India
CSIR Sponsored National Level Seminar on Advanced Biopharmaceutical Strategies- A Regulatory Perspective: July 13 14, 2012; Tirupati, India
4thInternational Congress of Pharmacy Graduates; Theme: Pharma Vision – Present & Future: October 6-7; 2012; Chennai, India.
Oman Pharmaceutical Conference 2013 on “Advances in Drug Delivery Systems and Pharmaceutical Care Practices; 17 – 18th April 2013; Muscat, Oman.



Licenses / Certifications
PROFESSIONAL DEVELOPMENT INITIATIVES
 International Conference on “Current Status and Future Perspective in Pharmaceutical Sciences”: Aug 19-20, 2011, Bangalore, India.
 International Conference on “Updates on Protein Drug Discovery, Formulation and Production Challenges,” October 28-29, 2011 in Tirupati, India
 CSIR Sponsored National Level Seminar on Advanced Biopharmaceutical Strategies - A Regulatory Perspective: July 13 14, 2012, Tirupati, India
 4th International Congress of Pharmacy Graduates; Theme: Pharma Vision – Present & Future: October 6-7; 2012; Chennai, India
 Oman Pharmaceutical Conference 2013 on “Advances in Drug Delivery Systems and Pharmaceutical Care Practices; 17 – 18th April 2013; Muscat, Oman.
 Published 25 Research Articles in reputed Journals.
 Published 3 Patents.
Publications and Patents Summary
Patents: 3
Papers published: 25
Presentations at conferences: 7

Additional Experience

Training / Seminars
Provide training /seminars on cGMP, product development, and regulatory requirements for USFDA, UK-MHRA, and TGA.
Marketing Experience
In-depth knowledge on manufacturing facility setup / R&D facility setup & product development and technical support on soft gel capsules; solid dosage forms, liquid dosage forms, and semisolid dosage forms.

Language Skills

Language Proficiency
English; Telugu; Hindi He has high level of proficiency in writing and spoken technical English.

Fields of Expertise

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