Dr. Srenivasarao
About Candidate
Hi
I am herewith enclosing my Resume for a suitable position in the esteemed organization either in Plant operations or in Quality Assurance or in R&D and I am also willing to relocate..
Currently I am working in Pellets Pharma Ltd as CTO with nearly 25 years of experience in numerous positions of increasing responsibility in Pharmaceutical formulation plants Internationally (New Zealand; Australia; Oman and India) from concept to commercialization. I enclosed my curriculum vitae as a first step in exploring the possibilities of employment.
My most recent experience was over all operations of commercial manufacturing (Plant Operations) and Quality Assurance (overall cGMP compliance) including R&D (Formulation Development), Technology transfer; commercial manufacturing 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 4 USFDAs / 2 UK-MHRAs / 2 TGA/ 3 EU- Germany / 1 SAPHRA (MCC) / 2 ANVISA / 3 MOH-Oman / 1 SFDA / & 2 GCC- central / ROW .
Currently Responsible for Leadership Management to oversee the day-to-day operational and administrative functions of firm’s Plant Operations; Quality Assurance; and Research & Development; and reporting all activities to Managing Director.
Work closely with external consultants as needed to implement the company’s overall business strategy, identify and select third party service providers and appropriate technology solutions for customer relationship management. Manage and develop strategic alliances and marketing relationships with other companies to increase business.
I can take-up the new assignment ASAP in any function and willing to relocate
If you need any information, please let me know
Mobile Number: +91 9550984131
Yours truly
Sreenivas
Location
Education
Work & Experience
Responsible to see overall Plant operations; Quality Assurance and R&D departments
Responsible for Leadership Management to overseeing 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 ect). Manage relationships with partners/vendors. Attainments: Streamlined the departments to meet organizational goals (turned the organisation to profits from Losses). Tie-up with new customers like P&G, DRL, GSK, ICM(Singapore), Marico and HUL ect 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.
Directing the entire Quality Assurance; Quality Control and Analytical Method Validations Teams of organization and supervising all regulatory audits. Look after day to day activities of Quality control and AR&D teams. Successfully completed 2-US-FDA, 1- EU ( Malta) and 1- ANVISA Audits
Lead highly skilled and qualified people to look after overall Quality of the plant (Non antibiotic, Antibiotic and Hormonal products) having approvals like US-FDA; UK-MHRA, TGA, RVO& BSG-Germany, MOH-OMAN, GCC-GULF for dosage forms such as tablets, capsules and liquids produced in-house as well as outsourced. Implementation and adherence of cGMP as per international guidelines. Also responsible for implementing, maintaining and ensuring the effectiveness of the quality processes for worldwide development of high quality pharmaceutical products and to ensure compliance with global regulatory requirements. Designing & Implementing / ensuring Compliance to Quality, Validation System & Analytical Assurance. Attending Regulatory and customer audits. Technical agreements review. Preparation & review of SOP & documents. Leading a group of well-trained group of people to look after overall quality control department activities like–Analytical Method validation, Analytical method transfers activity; Equipment and instrument validation protocol approval and certification. Review and approval of protocol and summary reports of compatibility study. Testing and release of In-process and Finished products. Leading highly motivated and target oriented team of scientists for product development/ analytical R&D teams to develop from conception through stability studies for US-FDA; UK-MHRA, TGA, RVO& BSG-Germany, MOH-OMAN, GCC-GULF etc,. Responsible for develop various kinds of dosage forms like TABLETS (IR & ER), Hard gelatin capsule, LIQUIDS; CREAMS/OINTMENTS from conception through stability trail. Developing Non antibiotic products, Antibiotic products (Cephalosporin) and Hormonal products.
