Expert Details
Product Development, Quality Assurance, GMP Audits, Qualifications, Troubleshooting, Pharmaceutical, Nutraceutical, Production Issues, GMP Compliance, Pharmaceutical Dosage Forms, Quality Control
ID: 726302
India
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, DRL, 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. |
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| 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. |
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| 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. |
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| 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 |
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| 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 Markets2. 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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 systemsTechnical support is given to local Pharmaceutical Companies |
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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
contract manufacturing, controlled-release drug delivery, gelatin capsule, tablet manufacturing, controlled-release oral drug delivery, pharmaceutical liquid, drug delivery, pharmaceutical capsule, drug dosage form development, over-the-counter drug product development, injectable pharmaceutical product, oral drug delivery, parenteral drug delivery, pharmaceutical drug, pharmaceutics, solid pharmaceutical product, drug formulation, softgel capsule, generic drug manufacturing, Current Good Manufacturing Practice, ophthalmic pharmaceutical product, suppository, generic drug, over-the-counter cosmetic, cytotoxic drug, dibasic calcium phosphate, medicinal herb, chewable tablet, polymer drug-delivery method, cosmetic exported product, cream, cosmetic product manufacturing, acne product, topical drug, drug analysis, controlled-release drug delivery technology, cosmetic product, new drug, drug regulation, veterinary medicine, veterinary hematology, transdermal drug delivery, pharmacokinetics, over-the-counter drug, ocular drug delivery, injectable drug, dosage form, auditing, audit failure, healthcare regulatory compliance