MOHANKUMAR EKAMBARAM

• Planning, Implementing and prioritizing Quality Control Systems and jobs as per Plant requirements w.r.t. Raw Materials, Packing materials, In process , Finished Products and miscellaneous samples in coordination with cross-functional teams.
• Establishing specification and Method of Analysis of Raw Materials, Packing materials, in process and Finished Products as per norms
• To train Staff, Operators and update their skills (cGMP, GLP, GDP, Data-Integrity, Safety, etc) and Troubleshooting
• Ensure completeness of documentation and validation of process and analytical methods as per cGMP requirements.
• Coordination with RnD, RA, QA, Maintenance, Stores, Admin., Production
• Having 25 + years of experience in QC of formulations
• Have faced international audits like EU GMP, WHO GMP, NPRA, Uganda, Customer audits etc. in a leading role
• Faced US FDA, EU GMP in previous tenures in leading role
• Validation Activities / AMV / AMT
• Administration of Microbiological activities
• QMS activities
• CAPA
• Laboratory Investigations
• Internal Trainer/ Auditor
• Competent Staff for testing functions
• Review of various chemical and microbiological documents
• Have an experience of closely working with Regulatory Affairs
• Have strong Analytical Skills
• Knowledge of QC analysis and interpretation of results, cGMP and GLP
• Analysis and Trouble shooting in analysis
• Managing Audits
• Knowledge of ISO 9000/14001
• Reviewing of Specs/STPs/SOPs/ATR/ADS/GTPs/COAs/Various protocols and reports
• Management of Analytical Standards
• Overall Maintenance of the QC Department and Team Management.
• Hard working, Positive Attitude, Excellent Communication Skills, Willingness to Learn
• Hands-on Approach, Energetic, Hardworking, Meticulous and Analytical Skills
• Good Leadership qualities and Interpersonal Skills
• Strong presence of mind
• Skilled at working independently and collaboratively in a team environment.
• Organized and detail-oriented with a strong work ethic.
• Used strong analytical and problem-solving skills to develop effective solutions for challenging situations.
• Participated in team projects, demonstrating an ability to work collaboratively and effectively.
• Developed strong organizational and communication skills through coursework and volunteer activities.
• Excellent communication skills, both verbal and written.
• Demonstrated strong organizational and time management skills while managing multiple projects.
• Passionate about learning and committed to continual improvement.

SUCCESSFULLY FACED US FDA, EU-GMP, INVIMA AUDITS AND OTHER MAJOR CUSTOMER AUDITS IN A LEADING ROLE

TRAINER

INTERNAL AUDITOR

INSTRUMENTAL IN IMPLEMENTING VARIOUS QUALITY IMPROVEMENT PROGRAMMES IN QC.

INSTRUMENTAL IN IMPLEMENTING 5S, KAIZEN, QCC, SQC, SPC

COST REDUCTION

TRAINER

ANALYSIS OF RAW MATERIALS. PACKING MATERIALS, IP, FP, STABILITY SAMPLES

CALIBRATION OF EQUIPMENTS

PREPARATION OF REAGENTS, VOLUMETRIC SOLUTIONS