Karthikeyan Muthuvel
Manufacturing Fill-Finish Injectable
- Role
- Manufacturing Lead at Caplin Point Laboratories Ltd
- Location
- Chennai, TN, IN
- LinkedIn followers
- 500 followers
About Karthikeyan Muthuvel
Pharmaceutical professional with 13+ years of experience in the entire lifecycle of sterile fill-finish injectable. I have a strong expertise in operation management, people management, mentoring supervisors & operators, leading cross-functional teams (PDN, QA, QC, MICRO, Engineering and Technology transfer), compliance management, planning management, Incident and Investigation management, media fill simulation and validation activities. I have proven ability and Hands on experience in maintaining quality organization of global compliance in worked pharmaceutical industries. I have involved overall project experience for production sterile injectable in Vial and Prefilled syringes. I have competent in global audit exposure of USFDA (USA), MHRA (UK), ANVISA (BRAZIL), TGA (AUSTRALIA), Health Canada, DCGI (INDIA) and other regulatory agencies. Proficient in handling communication with cross-functional teams and ensured manufacturing efficiency. Managed to make decisions that saved hundreds of thousands of dollars in manufacturing costs. Mentored various teams and individuals to integrate best practices in improving their performance results. Have been awarded various appreciations and merits for excelling business expectations. Proven experience in handling the highly demanding expectations in real-time emergency situations to increase production batches with quality compliance.
Experience
Manufacturing Lead
Mar 2024 — Present · Tamil Nadu, IN
Education
K.S.R College
Master of Science - MS, Biotechnology
2008 — 2010
Sri Kaliswari College - India
Bachelor of Science - BS, Biotechnology
2005 — 2008
Skills
- Gdp Practices
- Pharmaceutical Industry
- Sop
- Regulatory Guidelines
- Validation
- Biotechnology
- Cgmp Practices
- Life Sciences
- Biopharmaceuticals
- Formulation
- Technology Transfer
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