Mebin Joseph Babu
Indore
Summary
Dedicated pharmaceutical professional with over three years of experience in the pharmaceutical industry, specializing in quality assurance, formulation development, and GMP training. Holds an MSc in advanced pharmaceutical manufacturing, demonstrating agility in learning and staying up-to-date with industry advancements. Skilled in product optimization, cGMP compliance, and cross-functional collaboration, with a proven track record of executing laboratory experiments, scaling up formulations, and developing technical documentation. Aims to leverage strong pharmaceutical manufacturing background in product development to create innovative consumer products that meet market needs.
Overview
5
5
years of professional experience
1
1
Certification
Work History
Quality Assurance Analyst I
Teva Pharmaceuticals
01.2024 - 12.2024
- Company Overview: R&D Generics site
- Operational Support - Supported investigational medicinal product development through preparation of SOPs and following cGMP guidelines
- Initiated change control and deviation and followed up with relevant teams for CAPA implementation and closure
- Documentation - Reviewed and updated facility management documentation such as method SOPs and ensured training requirements were met
- Ensured all product quality reviews were completed in a timely and compliant manner
- Performed review of Bach records and instrument/equipment qualification records
- Training and mentoring - Supported site wide team through training and mentoring on SOP updates, navigation of Quality Management System and review of deviation investigation and approval
- Control and issue of documents - Managed issue of controlled documents such as SOPs, forms, logbooks, validation and qualification protocols
- Maintained comprehensive knowledge of relevant industry regulations and standards, ensuring compliance throughout the QA process.
- Acted as a liaison between the QA team and other departments such as Analytical Development, Product development, and Engineering, ensuring effective communication throughout all stages of the project lifecycle.
Formulation Scientist
Randox Laboratories
01.2023 - 12.2023
- Company Overview: Clinical diagnostic reagent services
- Product development - Led product development experiments for serum based diagnostic products developing formulations by applying scientific knowledge to develop products that aligned with the critical quality attributes and target product profile
- Demonstrate strong understanding of regulatory requirements
- Documentation - Accurately followed work instructions and adhered to Good Documentation Practices while completing Batch records, manufacturing logs and calibration records
- Prepared and ensured timely approval of technical documents such as development reports
- Scale up and transfer - Defined scale up plans and performed scale-up calculations to ensure seamless transfer from lab to production ensuring consistent quality and performance across batches
- Process Optimization - Participated in manufacturing automation project to streamline formulation activities and enhance accuracy in material dispensing and sequencing
- Cross functional collaboration - Collaborated closely with Quality assurance and Quality control to lead change management and issue investigation
- Technical expertise - Contributed towards planning and execution of a range of technical tests, summarizing and making correlations between them
- Streamlined production workflows by implementing process improvements such as automation, reducing time-to-market for new formulations.
- Performed pre-formulation studies, providing critical data for successful scale-up and commercialization efforts.
GMP trainer
Sun Pharmaceuticals
05.2020 - 06.2021
- Company Overview: Large site covering manufacturing of PENEM, Cephalosporin antibiotics and OTC product such as Revital
- Mentored new hires, resulting in stronger staff development and increased productivity.
- Provided one-on-one mentoring to help individuals reach their full potential within the organization.
- Developed Training Programs - Created training modules and delivered training on Good Manufacturing Practices (GMP), adherence to Standard Operating Procedures (SOPs), safety protocols, equipment operation, and process-related skills in production operation
Education
Master of Science - Pharmaceutical Sciences
University of Strathclyde
Glasgow, Scotland09-2022
Bachelor's Degree - Pharmacy
Rajiv Gandhi Technical University
Bhopal, India07-2019
Skills
- Quality Management System
- Electronic Document Management System
- Documentation skills
- Mentoring and training
- Root-cause analysis
- Project management
- Focus on regulatory compliance and quality output
- Auditing expertise (Internal, external and supplier)
- Presentation skills
- Lean Manufacturing (Six Sigma White Belt certified)
- English language (IELTS qualified overall 75)
- Ability to work in a team and independently in fast paced environment
Accomplishments
- Played a pivotal role in development and implementation of quality improvement project aimed at streamlining training delivery across site wide team through development of an automated platform.
- Demonstrated commitment to operational success through pre inspection audit before external audit and back room support during MHRA audit in April 2024.
- Achieved outstanding performance review during annual employee performance review and recognized for exceptional observation skills suring internal audit.
Certification
- Quality Management for Operational Excellence Certification (Project Management Institute, Oct 2024)
- Lean Six Sigma White Belt (LinkedIn learning, May,2024)
Timeline
Quality Assurance Analyst I
Teva Pharmaceuticals
01.2024 - 12.2024
Formulation Scientist
Randox Laboratories
01.2023 - 12.2023
GMP trainer
Sun Pharmaceuticals
05.2020 - 06.2021
- Quality Management for Operational Excellence Certification (Project Management Institute, Oct 2024)
- Lean Six Sigma White Belt (LinkedIn learning, May,2024)
Master of Science - Pharmaceutical Sciences
University of Strathclyde
Bachelor's Degree - Pharmacy
Rajiv Gandhi Technical University
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