R. Karthikeyan
Thiruporur,Tamil Nadu
Summary
More than Two and Half decades of success in spearheading manufacturing operations in the Pharma Industry for products including Sterile Formulation ,Tablets, Capsules, Oral liquid, products while ensuring quality compliance with major regulatory standards including NAFDAC, WHO CGMP & USFDA.
Over 20 years of hands-on experience in sterile formulation manufacturing, specifically in large volume parenteral (LVP) using Form-Fill-Seal (FFS) technology by Rommelag. Skilled in operating and managing critical process equipment, including sterilizers, mixing systems, packaging lines, and pharmaceutical-grade water systems (WFI, PW, and HVAC support systems). Versatile and detail-oriented pharmaceutical professional with 4+ years of additional experience in the manufacturing of oral solid dosage forms (tablets and capsules) and liquid formulations. Strong background in Manufacturing, Quality Assurance (QA) and Regulatory with proven expertise in GMP-compliant operations. Demonstrated success in handling regulatory audits and inspections from agencies such as NAFDAC, US FDA, and CDSCO. Proficient in manufacturing process validation, in-process and finished product testing, deviation management, CAPA implementation, and maintaining robust documentation systems to ensure quality compliance at every stage of production.
Working Experience in leading Pharmaceutical industry Wockhardt, Baxter, Euro life in India and Dana Pharmaceutical in Nigeria. Key Strength and Best in: Leadership, Results oriented, Strategic achiever, Strong work ethics and compliance, Managerial courage, competitive and Self-assured.
Overview
28
28
years of professional experience
Work History
Sr.Manager (Production,QA&Regulatory)
Dana Pharmaceutical Ltd
Minna, Niger-State
11.2021 - Current
- Coordination & Planning for routine Production daily, weekly, monthly.
- Handling the Infusion, Oral liquid, Tablet & Capsules plant shop floor activities.
- Handling The NAFDAC, ISO and SON audit.
- Managing manufacturing operations with 250 Permanent staff & 400 casual labor in shop floor.
- Responsible for Key performance indicator’s (Production volume, Product Quality, PQS/QMS, Product delivery, and Preventive maintenance schedule compliance.
- Handling the CAPAs, NCR (Deviation), OOT/OOS, Trends analysis and Market complaints & Investigation.
- Ensure Quality compliance (Process /Personal / Equipment / Clean room / Utility system)
- Manufacturing Intravenous fluids, Tablet, Capsules & Oral Liquid Facility
Operation Manager
Eurolife Healthcare Private Limited
Alathur, Chennai
10.2017 - 10.2021
- Achievement of production to the highest quality standards at minimum costs and specifically to motivate all employees towards the highest quality levels of the finished product.
- Continuously review plant process, methods, procedures and efficiency and ensuring that modifications to equipment, process, methods and procedures are in accordance with corporate standards and safety standards.
- Setting Annual Operating Plans (AOP) to control the manufacturing cost, Increasing Plant capacity enhancement, de-bottlenecking of various stages, capacity validation and process optimization.
- Responsible for Production, Quality and Engineering KPIs and efficiency improvement.
- Responsible for execution and timely completion of plant CAPEX.
- Working with Business teams for S & OP planning and dispatch plans.
- Determine the goals of the plant in accordance with Company Strategic Plan and Goal; and communicates it with the employees in the Department.
- Planning & implementing the preventive & predictive maintenance schedules for improving the overall reliability and safety of plant equipment in power intensive business operations.
- Monitor monthly progress of 1QSys and EHS compliance, On time closure of CAPA, CCM and Audit action items.
- Facilitate the compliance with all statutory standards to ensure that the facility is fully and consistently complaint with all applicable laws.
- Provides leadership for the development and direction of all team members involved in the preparation and presentation of monthly plant performance review, annual budgets and formulation of capital expenditures.
- Support to vendor developments for RM & PM and indigenous M/c Spares.
- Ensure CSR, Field visit and Employee engagement as per calendar.
- Promoting and providing the best environment to stimulate all team members and ensure harmonious Industrial relations.
- Manufacturing FFS bottles (IVs) Rommelag at Alathur Facility
Asst. Manager Production & Team Leader Production
Baxter India Pvt Ltd
Alathur, Chennai
06.2013 - 10.2017
- Continuously strive for improvements in material utilization, equipment utilization, and reduction of waste, cost reduction and process improvement program.
- Driving volume efficiency to meet budgeted volume and financial targets.
- Responsible for driving continues improvement through Kaizen and Lean project implementation.
- Creating problem solving culture through implementation of EMS (Operational Excellence Management System).
- Responsible for driving energy saving projects and implementation of Employee Suggestion.
- Overall responsible for Production & Engineering Key performance indicator’s (Production volume, Product Quality, Product delivery, Power/FO consumption and plant Preventive maintenance schedule compliance).
- Handling the CAPAs, NCR, and Market complaints & Investigation.
- Ensure Quality compliance (Process /Personal / Equipment / Clean room / Utility system).
- Manufacturing FFS bottles (IVs) at Alathur Facility
Sr.Executive Manufacturing
Baxter India Pvt Ltd
Alathur, Chennai
08.2002 - 06.2013
- Managing manufacturing operations with 50 direct employees in shop floor.
- Responsible for manufacturing activities (Mixing, steriliser and packing), which include new product / lines, meeting production targets, managing work effectively and improving product quality.
- Continue to improve customer service level through focused initiatives & Improve customer understanding and interface.
- Ensure key quality processes are managed and continuously improved through leader standard work, visual management and the daily accountability processes.
- Develop Productivity strategy towards cost reduction and manpower optimization.
- Meet the Production volume & Control and meet the budgeted conversion loss.
- Develop and execute strategy towards healthy employee-employer relationships, supporting towards the goal of 'Non-unionized environment'.
- Continue to execute a comprehensive strategy to ensure an injury free workplace.
- Co-ordinate, plan, evaluate and provide training for all subordinates.
- Manufacturing FFS bottles (IVs) at Alathur Facility
Production Chemist
Wockhardt health care Ltd
Alathur, Chennai
03.1998 - 08.2002
- Ensure the plant and its machineries are in state of qualification.
- Ensure the products are delivered to customers as per desired quality and delivered on time.
- Worked as Shift Manufacture chemist (Batch manufacturing & Filtration process).
- Worked as shift in charge in sterilization and Packaging activity.
- Involved in Equipment validation & Facility Validation activity.
- Manufacturing FFS bottles (IVs) at Alathur Facility
Education
B. Pharmacy - undefined
Annamalai University
M. Pharmacy - Pharmaceutices
Dr MGR-Medical University
M.A - Yoga
Madras University
Skills
- Employee safety
- Product quality
- Product delivery
- Manufacturing cost
- Continuous improvement
- Customer focus
- Dedication to safety
- Quality consciousness
- Cost consciousness
- Operational excellence
- Succession planning
- Talent development
- Employee engagement
- Performance targets
- CAPA
- Complaint management
- Inspection readiness
- Cost of quality (COQ)
- Product performance
- Process performance
- Problem solving
- Accountability
- Enterprise Management System (EMS)
- Capacity planning
- Asset efficiency
- Product service levels
- Product code mix
- Release time (OTBR)
Languages
Tamil
English
Personal Information
- Age: 49
- Father's Name: Ramalingam
- Date of Birth: 06.06.1975
- Nationality: Indian
Mobile
- +91 9566191119, India
- +2348126019023, Nigeria
Spouse
Geetha. P
Current Salary
$2010 USD + Local Allowances
Travel Passage
Every Six Month Once
Training
- Training for CAPA, CCM & JDE-Manufacturing software
- Baxter EMS - advanced version of Operational Excellence Training
- Lean boot Camps (LBC)
Timeline
Sr.Manager (Production,QA&Regulatory)
Dana Pharmaceutical Ltd
11.2021 - Current
Operation Manager
Eurolife Healthcare Private Limited
10.2017 - 10.2021
Asst. Manager Production & Team Leader Production
Baxter India Pvt Ltd
06.2013 - 10.2017
Sr.Executive Manufacturing
Baxter India Pvt Ltd
08.2002 - 06.2013
Production Chemist
Wockhardt health care Ltd
03.1998 - 08.2002
B. Pharmacy - undefined
Annamalai University
M. Pharmacy - Pharmaceutices
Dr MGR-Medical University
M.A - Yoga
Madras University