Summary
Overview
Work History
Education
Skills
Websites
Accomplishments
Timeline
Generic

BHAVANA KUMAR VANGARA

Dublin

Summary

Pharmaceutical Manufacturing Specialist with over 4 years of experience in GMP-regulated environments. Expertise in batch production setup, process troubleshooting, and quality assurance. Demonstrated success in leading shifts, implementing lean initiatives, and training personnel to achieve operational excellence.

Overview

6
6
years of professional experience

Work History

Biotech Associate

MSD
01.2025 - Current
  • Prepare, thaw, and expand mammalian cell lines. Monitor cell viability, density, and growth kinetics. Maintain sterility throughout cell culture processes using aseptic techniques.
  • Prepare and filter growth media, feeds, and buffers. Ensure media is formulated accurately and documented per SOPs.
  • Maintain an inventory of raw materials and reagents.
  • Set up (Single use systems), calibrate, and operate shake flasks, wave bags, benchtop, and large-scale bioreactors (up to 2,000 L). Monitor and control parameters. Troubleshoot equipment or process deviations.
  • Collect and analyze samples at different growth phases. Perform or support in-line and at-line analytics (e.g., metabolite analysis, pH, osmolality). Document results clearly, and ensure traceability by using GLIMS
  • Follow cGMP, GLP, and SOPs rigorously.
  • Assist in deviation investigations or CAPAs as needed.
  • Support tech transfer of processes from development to manufacturing. Participate in scale-up studies for process optimization.
  • Collaborate with downstream and quality teams to ensure smooth handoff.
  • Supported shift handovers, updating Tier boards, and visual management tools to ensure a seamless transition and awareness.
  • Maintained and reviewed production documentation, including batch records, trend logs, and EM data.
  • Clean and sterilize equipment.
  • Perform routine maintenance on bioreactors and ancillary systems.
  • Work closely with downstream process teams, Quality Assurance and control teams, Engineering and validation teams.
  • Suggest and implement process improvements or optimization strategies.
  • Operate and troubleshoot automated bioreactor control systems (e.g., DeltaV).
  • Use electronic batch records (EBR) and lab information management systems (LIMS), validation software (Kneat Gx).
  • QMS software (Trackwise).
  • Trained in microbiological activities like Environmental monitoring and aliquoting.

Production Member

OMNIACTIVE HEALTH TECHNOLOGIES
12.2022 - 06.2023
  • Performed SAP Activities: Accountable for the generation of process orders, batch determination in accordance with process orders, issuance, return, and rejection of materials, recording of finished goods receipts, and meticulous maintenance of recovery stock as per SAP requirements.
  • Prepared and Reviewed BMR: Ensured thorough preparation and review of Batch Manufacturing Records (BMR) to guarantee accuracy, compliance, and adherence to production protocols and regulatory standards.
  • Developed and Maintained QMS: Led initiatives to develop and implement solutions to sustain and improve the Quality Management System, ensuring alignment with regulatory standards.
  • Created Validation Protocols: Developed a wide array of Validation Protocols and a comprehensive Validation Master Plan to uphold stringent quality standards and ensure consistent production efficacy.
  • Process Validation: Conducted process validations and qualifications, ensuring adherence to customer requirements and regulatory standards.
  • Quality Issue Resolution: Provided quality support to resolve manufacturing issues and participated in the CAPA process for continuous improvement.
  • Coordinated Planning and Execution: Effectively planned and coordinated daily production activities with planners and various cross-functional teams, ensuring seamless execution and timely completion of production targets.
  • Led daily shift meetings and Tier board discussions to ensure alignment with the production plan and safety goals.
  • Managed Team: Supervised and managed a team of approximately 15 technical staff members, ensuring effective communication, task delegation, and maintenance of high productivity levels.
  • Strategically allocated manpower and coordinated with team members to execute daily production plans, ensuring optimal use of resources and meeting of production deadlines.
  • Conducted on-the-job training and competency evaluations, ensuring adherence to GMP and safety protocols.
  • Provided Technical Support: Given expert technical support to operators and executives, troubleshooting and resolving issues promptly to ensure smooth and uninterrupted production processes.
  • Oversaw raw material handling, safety checks, and sanitization procedures in alignment with EHS standards.
  • Collaborated with Engineering Team: Coordinated with the engineering team for the installation and commissioning of new equipment, ensuring the commercial facility was prepared and operationally ready.
  • Compliance Activities: Maintained compliance with regulatory requirements, supported audits, and ensured the facility met environmental, health, and safety standards.

Production Executive

GRANULES INDIA
06.2022 - 12.2022
  • Established Manufacturing Processes: Established and implemented comprehensive processes for trial, pre-validation, and validation stages in the manufacturing area, ensuring that each phase adhered to industry standards and supported the production of high-quality products.
  • Monitored Validation Batches: Conducted thorough monitoring of pre-validation, validation, and post-validation batches to ensure that each stage of the manufacturing process met stringent quality standards and complied with regulatory requirements.
  • Process Control Programs: Developed and implemented process control programs to optimize quality and meet production targets.
  • Troubleshot Shop Floor & Validation Issues: Identified and resolved various issues encountered on the shop floor during production execution, applying problem-solving skills to maintain operational efficiency and prevent production delays.
  • Prepared and Reviewed Documentation: Prepared and reviewed Batch Manufacturing Records (BMR), Batch Packaging Records, Validation protocols and other critical documentation to ensure accuracy, compliance with regulatory standards, and effective record-keeping of production activities.
  • Training and Mentorship: Trained staff on Quality Procedures including GMP, Audit Prep, and compliance.

Production Associate

LAURUS LABS
12.2020 - 06.2022
  • Planned and Controlled Departmental Activities: Coordinated and managed departmental activities on a daily basis, meticulously planning and controlling operations to ensure alignment with production requirements & organizational goals, thus facilitating smooth and efficient workflows.
  • Executed Production Schedules: Developed and executed detailed production schedules based on activity requirements and area specifications, ensuring that all production processes were carried out according to planned timelines and operational needs.
  • Setup and operated different equipments according to the SOPs and routed documents.
  • Managed Daily Planning and Work Allocation: Oversaw daily planning activities, including the strategic distribution of manpower and allocation of tasks, to optimize workforce efficiency and meet production targets effectively.
  • Monitored Productivity and Process Stages: Actively monitored IPQC activities during the manufacturing stages of Oral Solid Dosage forms, performed line clearance at various stages of the process, and prepared daily and monthly reports to assess and enhance productivity.
  • Assisting the department head in the development of systems, SOPs, and documentation in line with cGMP.
  • Validation and Compliance: Coordinated validation activities, ensured compliance with GMP, and monitored in-process controls.
  • Assisted in creating and refining SOPs for validation processes.
  • Audits Support: Assisted in preparing for internal and external audits by ensuring process documentation was up to date.

Quality Control Technician

Reckitt
01.2020 - 12.2020
  • Prepare and label samples for testing, ensuring accuracy and compliance with standard procedures.
  • Collect samples of raw materials, in-process materials, and finished products.
  • Document test results accurately in lab notebooks or software systems.
  • Routine maintenance and calibration of laboratory equipment like pH meters, spectrophotometers, and balances.
  • Participate in continuous improvement projects to optimize quality control processes.
  • Communicate effectively with various departments to coordinate on quality issues and ensure products meet required standards.
  • Support the quality control team during internal and external audits.
  • Coordinate with production, quality assurance, and R&D teams for sample testing, deviations, and batch release documentation.

Intern Quality Control

Deccan chemicals
09.2019 - 12.2019
  • Participate in investigating deviations and Out-of-Specification (OOS) results to identify potential improvements.
  • Assist with inventory management of reagents, standards, and consumables in the QC laboratory.
  • Complete training on Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) for the pharmaceutical industry.
  • Assist in environmental monitoring of the QC laboratory and production areas to ensure compliance with cleanliness standards.
  • Work under supervision to maintain sterile conditions and proper disposal of samples, reagents, and other waste.
  • Help maintain logs of equipment calibration, usage, and maintenance activities.

Education

MSc - Digital Transformation (Life sciences)

Griffith College Dublin
01.2024

Masters - Pharmaceutics

Acharya Nagarjuna University
01.2022

Skills

  • Quality management systems
  • Aseptic Manufacturing
  • Validation and Qualification
  • MES, SAP, GLIMS, Kneat GX, DeltaV
  • Technology tranfer
  • Analytical Techniques
  • Cross-functional collaboration
  • Deviations, Change controls, CAPA
  • Organizational and communication skills
  • Internal and External Audits

Websites

Accomplishments

  • Led a team-based root cause analysis that resolved recurring material handling errors, improving batch yield.
  • Reduced deviation rate by 30% through proactive CAPA management and cross-functional training.
  • Developed a process control dashboard using SPC tools to monitor cell growth kinetics, leading to improvement in yield consistency.
  • Spearheaded a tech transfer project that enabled successful scale-up of mammalian cell culture to 2000L bioreactors.

Timeline

Biotech Associate

MSD
01.2025 - Current

Production Member

OMNIACTIVE HEALTH TECHNOLOGIES
12.2022 - 06.2023

Production Executive

GRANULES INDIA
06.2022 - 12.2022

Production Associate

LAURUS LABS
12.2020 - 06.2022

Quality Control Technician

Reckitt
01.2020 - 12.2020

Intern Quality Control

Deccan chemicals
09.2019 - 12.2019

MSc - Digital Transformation (Life sciences)

Griffith College Dublin

Masters - Pharmaceutics

Acharya Nagarjuna University

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BHAVANA KUMAR VANGARA