VENU GOPALA REDDY LANKA

PRODUCTS HANDLED :
Anti hypertensive (CILAZAPRIL )

Anti hypertensive ( RAMIPRIL)
Anti-fungal (TERBINAFINE HCL)

Anti-fungal (VORICONAZOLE)
Anti-psychotic (ARIPIPRAZOLE)
Anti- retro viral (DARUNAVIR AMORPHOUS )

Anti- retro viral (DARUNAVIR ETHANOLATE)
Anti allergic & Antihistaminic agent (RUPATADINE FUMARATE)
MAN POWER HANDLED:
Operators,Chemists,Shift in charges,Executives,Sr.Executives,Asst.Managers
Dy.Managers,Engineering, Ware house & Civil People.

• Lead the manufacturing analytical laboratory using Lean and Operational Excellence tools while preventing waste and providing on-time results to maintain manufacturing production schedule of 18 commercially licensed products.
• Enhanced group productivity and process improvement 75% with development and implmentation of new sample testing and documentation strategy using electronic batch record (EBR).
• Ensure that manufacturing facilities, equipment, processes and procedures are compliant with cGMP requirements and applicable regulations.
• Maintain laboratory quality service by enforcing quality and customer service standards.
• Provide and analyze production and laboratory metrics for site and corporate management business reviews.
• Analyze and resolve laboratory issues, manage deviations (Non-conformances), participate in investigations and support processes to establish robust CAPA's and Change Controls.
• Review laboratory operations and interact with cross functional teams (Quality, Engineering and Process Development) to resolve production and processing problems.
• Participate in regulatory agencies and internal corporate audits.
• Primary point of contact for evaluation of compendia changes impacting the site.
• Participate in Method Transfer activities for new products.
• In depth knowledge of Laboratory working principles, Good Documentation Practices and Good Laboratory Practices (GDP and GLP).
• Accomplish staff results by communicating job expectations, planning and monitoring.
• Assess laboratory capacity, strategize and deliver results on time.
• Coordinate and plan detailed laboratory work plans/schedules.
• Identify opportunities and drive initiatives to reduce error, gain laboratory efficiency and reduce cycle time.
• Responsible for interviewing applicants, recommend individuals for hiring and evaluation of staff performance.
• Understand, use and execute in laboratory electronic systems (EBR and LIMS) and Quality systems.
• Understanding of Human Resources policies and Puerto Rico Labor Law.
• Responsible for coaching, counseling, and disciplining employees; developing, coordinating and enforcing systems, policies, procedures and productivity standards.
• Foster a positive working environment of partnership, transparency and teamwork throughout the department and organization.
• Tracked new material shipments and coordinated flow of materials at different stages of manufacturing to align with procurement expectations.
• Evaluated suppliers to maintain cost controls and improve operations.
• Set product standards, examining samples of raw products and processing tests, to monitor quality of finished products.
• Supervised production team, keeping production schedules on track to meet tight deadlines.
• Introduced new methods, practices, and systems to reduce turnaround time.
• Evaluated employee skills and knowledge regularly, training, and mentoring individuals with lagging skills.
• Made sure that products were produced on time and are of good quality.
• Anticipated and addressed production problems, material shortages, equipment malfunctions, and unavoidable delays.
• Changed equipment over to new products to meet customer requirements.
• Reviewed processing schedules and production orders concerning inventory requirements, staffing requirements, work procedures and duty assignments, considering budgetary limitations and time constraints.
• Minimized resource and time losses by addressing employee or production issue directly and implementing timely solutions.

• Leading plant production Operations, site compliance functions with a team strength of 35 members and overall responsible for total about 12 manufacturing blocks QMS activities, implementation of quality systems & responsible for compliance activities, Production, raw material planning and man power planning according to the production target.Handling of external/Internal auditors during GMP/Periodical audits.Providing the response to the internal / external audit observations.Review of Pre-Validation / validation / commercial documents.
• Attending technology transfer meetings.Providing inputs during technology transfer from R&D / other sites.Over all site new products validations and Production planning as per monthly projections.Supporting to regulatory department for submission of dossiers and complying regulatory deficiencies.Vendor Quality Audits and evaluation with respect to compliance to GMP.Receiving Purchase orders from various customers for finished products (APIs) anddistributing the same to the customers as per their requirements.

Roles as Jr.Chemist to Sr.Chemist in Production Manufacturing from 2003 to 2006 :
* Execution of Intermediates/API manufacturing operations as per BMR.
* Reactions,Separations,Centrifugation's ,Filtrations,Drying,Operations.
* Following Safety rules as per company policies.
* Equipment handled:Reactors SSR,HLR and GLR ,Centrifuges,Nutsche filters,Pressure

filters,Leaf filters and Tray Driers.
Roles as Jr. Executive to Executive in Production Manufacturing from 2007 to 2010 :
* Handling of Crystallizer and Clean Room operations.Crystallization,Drying,Powder Processing

Operations like Pulverizing,Milling,Micronising,Blending,Sifting and Packing operations.
* Equipments handled: Reactors SSR,HLR and GLR ,Centrifuges,Nutsche filters,Pressure filters,

Leaf filters ,Tray Driers,Vacuum tray Driers,Pulverizers,Millers,Ultra fine miller,Micro pulverizers,

Micronisers and Sifters.
* Maintenance of clean rooms and clean room validations.Size Reduction Operations of API to

the Various Customers on Product Particle size requirements (Spec & MOAs), BD /TD

requirements etc...
* Blending Operations of API based on Customer requirement to enhance the Batch Size of API.
* Good exposure on API Container Closure System (Packing and Re-Packing Operations)
* Planning and execution of pre exhibit and exhibit batches at plant as per cGMP.
* Receiving Purchase orders from various customers through PPIC department for finished

products (APIs) and distributing the same to the customers as per their requirements.
* Keeping quality documentation up to date.
* Finished product dispatch to various customers.
Roles as Sr. Executive in Production Manufacturing Shift Incharge from 2011 to 2014 :
* Execution of Process Validations for new Products/Scaleup/ Scale-down.
* Execution of Cleaning Validations in the multi products facility.
* Execution of Re-Processing/Re-Work/Re-Validations as per requirement as per cGMP.
* Preparation of SOPs,Protocols for Process Validation and Cleaning Validations.
* Preparation of Reports for Process Validation and Cleaning Validations.
* Product CC reducing Unit Operations by using the recovery Solvents/ Materials as per cGMP.
* Process trials in laboratories, pilot plants or in plant scale.
Roles as Asst. Manager in Production department from 2015 to 2018 :
Worked on over all site QMS Elements :
* Change Control/CAPA Management
* Incident/Deviation Management
* OOS/OOT Handling
* Pre-Validation/Process Validations for new products
* Cleaning Validations
* Re-Processing/Re-Work.
* Audit response preparation against the customer audits.
* Involving in RA related quarries.
* Investigations preparation against Cpk/CPV failure,OOS/OOT, Complaints, Return Goods.
* Qualification activity of equipment/Facility.
* Quality Risk Assessments.
* Vendor/Supplier audits
Roles as Manager in Production Manufacturing as Block Incharge From 2019-2022:
* Production planning and Inventory Control as per monthly projection with 25.0 cr per month.
* Co-ordinating with warehouse for supply and stock of raw materials for current month

production as well as inadvance for next 3 months.
* Increase production, assets capacity and flexibility while minimizing unnecessary costs and

maintaining current quality standards.
* Coordination with marketing & the purchase dept. for the dispatch, market requirement, special

requirements time to time as well customer/Marketing sample for new registration.