Flat No.***, Sai Durga Residency, ITI Road, Bharath Nagar, Kurmannapalem,
Visakhapatnam, AP 530046, India. Cellular +91-995******* Email Id: email@example.com; Skype Id: Satyanarayana Seetalam PHARMACEUTICAL STERILES(INJECTABLES) MANUFACTURING PROFESSIONAL With Expertise in Pharmaceutical Steriles(Injectables) Manufacturing and Fill Finish Line activities. Resourceful, analytical and detail-driven individual with capabilities in completing multiple tasks with competing deadlines. Aggressive in identifying and resolving inefficient operational processes. Strong team member, able to motivate crews to achieve optimal production rates while maintaining high safety methods and practices. Reliable follow-through skills, fulfilling all administrative requirements from field activities. Clear communicator, both oral and written. Interpersonal skills interface effectively with co- workers, management and customers. Excel in unpredictable and hectic environments. Strengths include:
Change controls/QRM Handling • Solution Preparation & Compounding activities
Process Validation • Fill Finish Line activities
Clean room practices • Regulatory Compliance
IMEX Program • Process & Performance Optimization
Troubleshooting/Investigating ER’s • Personnel Supervision MANUFACTURING PROCESS & PRODUCTS
Sterile Water for Injection(Aqueous vehicle)
Bacteriostatic Water for Injection(Aqueous vehicle)
Bupivacaine HCL Injection(0.25% & 0.50%) (Anaesthetic)
Sodium Acetate 2mEg/mL Injection(Electrolyte)
Ketorolac Tromethamine Injection(NSAID)
Lidocaine Hydrochloride Injection 2%(Local Anaesthetic)
Potassium Acetate 2mEg/mL Injection(Electrolyte)
Furosemide 10mg/mL Injection(Diuretic, Hypotension)
Propofol Emulsion Injection(General Anaesthetic) SKILLS
Innovation: Apply new technologies and methods to improve service.
Management: Coordinate professionals to deliver integrated, high quality operations.
Planning: Institute long-range forecasting for growth and improvement.
Technical expertise: In-depth knowledge of diverse aspects of validating process equipments of Fill finish line.
Pfizer Healthcare India Pvt. Ltd, Senior Executive, Visakhapatnam, AP, India, 2017 to Present
Working as a Manufacturing Supervisor for processing of Manufacturing (Solution & Component Preparation) and Fill-Finish Line activities(Washing, Filling, Capping & Vial Collection ) as per procedures
Handling all the process related SOPs, Drawings, Specifications, Qualification protocols etc in PDOCS system(Pfizer Documentation Management System).
Participating in routine formulation activities during the manufacturing of Drug product.
Participating in routine manufacturing operations like CIP of Mixing and Holding vessels, COP of Filling machine parts, Pre and Post activity clearances. NVPC monitoring,, Area Upkeep, EMS&BMS monitoring, inprocess checks, visual inspection, sterilization activities
Experienced in utilization of Quality tools like Change controls, investigations(Track wise), CAPA’s, QRM’s etc when there is need to justify the deviations.
As a Safety Zone Member, escalating the safety issues in the process and implementing the CAPA actions with coordination of EHS Team to avoid safety incidents.
Experienced in handling of Electronic systems like SAP, AMPS, GLIMS, EAMS &PLS(Pfizer Learning system software)
Note:(1)As a part of Part Washer Project, attended FAT(Factory Acceptance Test) twice conducted at Fedegari Autoclavi SPA premises, Pavia, Albuzzano, Italy-27010, Dec-2017 and Feb-2018.
(2)As a Pfizer representative, attended Scissor Lift Quality Verification Test conducted at Pune, Aug- 2018
Hospira Healthcare India Pvt. Ltd, Executive, Visakhapatnam, AP, India, 2015 to 2017
Responsible for processing of Manufacturing and Fill- finish Line activities as per the procedures.
Responsible for Activity planning and deploying the personnel according to the plan.
Conduct real time Batch Manufacturing Record(BMR) review in assigned area
Ensure area upkeep with adequate identification of machines and materials
Ensure compliance of clean room behavior, discipline and personnel hygiene to procedures and adequate cleaning, sanitization to area and equipments.
Coordinate with support cross functional departments for smooth operation of Production activity.
Initiating CCFS(Change Control Forms) related to documents, equipment. Ensuring their closure and implementation of changes within the specified time.
Identify deviations/ exceptions and escalate to Manager by appropriate procedures.
Initiate and assist ER(Exception Report) investigations as applicable
Preparation of trail run protocols related to Exceptions.
Raise requests to Engineering in the event of breakdown/maintenance-Certify the same after completion.
Responsible to carry out the below operations of the process equipment as per the schedule.
IQ/OQ/PQ(Installation, Operaional and Performance Qualifications)
PRQ’S(Periodic Requalification) of Area and Equipments
Periodic Review of Procedures and Equipments
Provided technical support in design, selection and process path of cGMP Compliant Parts Washer(Purpose: Cleaning of Product contact Accessories) for TS Block at Hospira Healthcare India Pvt Ltd.
Ensure adherence of Manufacturing procedures met the quality systems, GMP's and statutory requirements.
Promoted Continuous Improvement by utilizing a team approach to identifying and providing effective solutions to Manufacturing process operational problems.
Particicpated internal and external(Regulatory & Non Regulatory) audits.
Ensure compliance of operations to cGMP, safety and integrity at all stages of activities.
Supervised and trained 10 employees in daily processing operations of Manufacturing activities.
Hospira Healthcare India Pvt. Ltd, Junior Executive, Visakhapatnam, AP, 2012 to 2015
cGMP and its application of Quality Management systems
Good documentation practices and technical writing & document review skills.
Ability to write and revise SOP’s(Standard Operating Procedures), URS(User Requirement Specifiecation) and related Manufacturing and Filling documents.
Strong technical knowledge on Fill Finish Line activities.
As a part of process, involved in the integrity testing of Capsule and Cartridge Filters with IT4 Machine(Make: Millipore).
Handling, storage and reconciliation of materials.
Handling, storage and retrieval of different types of machine change parts based on the vial/ampoule size
Experiences in good understanding of Manufacturing and Quality systems
Analytical thinking to grasp complex technical issues and provide feasible solutions by Decision making on activities in the area according to GMP procedures.
Ability to communicate effectively with all levels within the organization.
Investigated and resolved manufacturing operation problems, which resulted in improved operational efficiency levels within the organization.
Troubleshoot technical issues when the need arises, and escalating appropriately as needed.
Responsible for Scheduled monitoring of Non viable particle count(NVPC) for the area.
Involved technically during the Installation and Qualification of AVSRS Machines(Automatic Vertical Storage and Retrieval Systems, Purpose: Storage of Change parts and Accessories) for TS Block at Hospira Healthcare India Pvt Ltd.
Vasudha PharmaChem Pvt. Ltd, Unit-II, Chemist, Visakhapatnam, AP, 2010 to 2012
Resposible for Inprocess analysis and sampling.
Resposible for raw material sampling and Analysis.
Providing online documentation of Analytical reports and Preparation of Specifications of Packing Materials and STPs(Standard Testing Procedures)
Responsible for Initiating Change controls.
Supervised and trained 05 employees in daily processing of Sampling and analytical activities
Project : Pfizer Healthcare India Pvt Ltd
Scope : Supervising the Manufacturing Process Operations and Compliance activities
Duration : 2017 to Present.
Project : Hospira Healthcare India Pvt Ltd,
Scope : Installation and Qualification of Process Equipments in TS Block and Involved from initial stage Exhibit batches to till date Commercial batches.
Duration : 2012 to 2017.
Project : Vasudha Pharma Chem Ltd.
Scope : Supervising the sampling and analytical activities of raw and inprocess materials along with Quality documentation.
Duration : 2.5 years.
Bachelor of Pharmacy, 2009
Nova College of Pharmacy, Jawaharlal Nehru Technological University, Kakinada, Andhra Pradesh, India GPA: 75 % - First Class with distinction.
Moving and Aligning to Excellence, Skillsoft, 2015 to 2015
First aid and Basic Fire Fighting, Safety Training, 2016 to 2016.
Training the teams on relevant procedures and getting trained on the respective area of work.
Qualified Trainer for the Pfizer Healthcare India Pvt Ltd Vizag Facility
Attended the Method1 Training for handling Investigations and Trouble shooting 2017. COMPUTER SKILLS
Word, PowerPoint, Excel, Outlook, Internet Research.
Hands on working in SAP, AMPS, GLIMS & EAMS environment as a process and to execute Electronic Batch Records
Handling of Electronic Quality Tools like Trackwise, Global Trackswise Management system(gQTS) etc PROFESSIONAL REFERENCES
Available upon request