Manoj Tripathi
Satna
Summary
Dynamic professional committed to maximizing potential and driving organizational growth through a collaborative, quality-focused environment. Extensive knowledge and experience in FDA-approved small volume parenteral processes, demonstrating a strong foundation in regulatory compliance and technical proficiency. Seeking opportunities that promote personal development while making impactful contributions to organizational objectives.
Overview
20
20
years of professional experience
Work History
DEPUTY GENERAL MANAGER
LUPIN BIOTECH – PUNE
05.2025 - Current
- Responsible for fill finish section: Combi line (PFS and Vial).
- Responsible for packing operation. (PFS Denesting , Plunger rod insertion and labelling machine , PFS Pen device assembling , PFS Blister pack operation.
- Responsible for QMS related activity of the department.
- Responsible for the recruitment of the department.
Deputy General Manager-Production
AUROBINDO PHARMA UNIT-XII BACHUPALLY (HYDERABAD)
11.2023 - 03.2025
- Heading the Injectable lines and responsible for the Injectable block which includes the Activity Dispensing to Packaging.
- Processing line configuration includes (Two Aseptic Processing line , Dry Powder Injectable and Liquid line dedicated for lyophilized products , liquid line caters two lyophilizer identical with each other.
- Secondary Packaging area having two packaging lines includes labeler, cartonator, serialization equipment’s and check-weigher etc.
- Responsible for facing the regulatory audits and customer audits.
- Responsible for the recruitment of the department.
- Responsible for Process & equipment troubleshooting, equipment / facility up-gradation & qualification.
- Responsible for the initiation and handling of Quality management system which includes Change control, CAPA, Process nonconformance, OOS and OOTs.
- Responsible for the Budget preparation.
- Integration of online non-viable particle counting system with filling machine (Strengthen the process controls)
- Development of Aseptic setup process – Liquid line. (Hopper was fixed , made removable and included in aseptic setup)
- Aseptic practice procedure was upgraded with respect to observations cited by USFDA Inspectors in other units.
General Manager Production
Shilpa Medicare Limited (Unit -IV)
01.2023 - 10.2023
- Responsible for the Handling of the Regulatory Audits, customer audits and compliance of the observations.(Regulatory audit completed – TGA)
- Responsible for the recruitment of the department.
- Responsible for the Budget preparation of solid oral and injectable department.
- Handling of three Inject able blocks having the Isolator equipped filling line & Oral solid dosage form.
- Qualification completed for the isolator based filling line and started the commercial activity.
- Training to subordinates and juniors in-order to strengthen their capability to face the regulatory audits.
- Process & equipment troubleshooting, equipment / facility up-gradation & qualification.
- Completed the customer audit and got the clearance from Novartis and Demo-pharma.
- Successfully completed qualification of two lyophilizer (LSI Make) and Three isolators which are the part of capacity enhancement project.
- Faced Novartis audit and all the observation cited by the auditors are minor against which CAPA submitted and accepted by the customer.
General Manager Production
Immacule life-science Pvt. Ltd
01.2022 - 01.2023
- Responsible for the production and compliance of the production department including packaging.
- Responsible for the Handling of the Regulatory Audits, customer audits and compliance of the observation.
- Appreciated by the USFDA auditor for the demonstration of the aseptic practices. Aseptic setup and Man and Material movement.
- Responsible for the recruitment of the department.
- Responsible for the Budget preparation.
- Face the customer audit i.e. M/s Sagent , M/s Provepharm, M/s Pharmanovia , M/s Cipla , M/s SRS, M/s Apotex , M/s Stira , M/s Xelia , M/s Inventia etc.
- Responsible for maintaining the quality and compliance culture in the department.
- Responsible for the Vial, Ampoule and Lyohilization operations.
- Faced Recently : 06 Jun 22 to 13 Jun 22
Indoco remedies GOA -Unit-III
- Left early due to family problem
ASSISTANT GENERAL MANAGER –OPERATIONS
BIOLOGICAL EVANS PVT. LTD. (FORMELY KNOW AS AKORN INDIA PVT. LTD.)
05.2016 - 05.2021
- Responsible for operation of 04 production blocks i.e. (General Block, Carbapenem Block, Cephazoline Block, and Hormone Block).
- Designing of the New General Injectable Block and Lines as per the cGMP & Regulatory requirement.
- Evaluation of technical offers and design review of integrated vial lines, Autoclaves.
- Technology transfer of products those are to be transfer to AIPL site and evaluation of the product with respect to available resources.
- Equipment and Facility Qualification as per the schedule.
- Training to subordinates and juniors in-order to strengthen their capability to face the regulatory audits.
- Completed quality system redeployment and production facility remediation.
- Process & equipment troubleshooting, equipment / facility up-gradation & qualification.
- FAT: Inspection Machine (Make : Bosch , AIM 5021), Part washer (Make : Steelco Italy), Manufacturing vessels and CIP & SIP systems (Make : M/s Praj).
- Plant Capex management, Opex Management.
- Implementation of new software in core production team- LMS (Learning management system), DCMS (Document management system), Track wise.
- Leading investigations related to production deviations/incidents and arriving, at root causes and implementing CAPAs.
- Escorting auditors to the production floor and facing audits (regulatory and clients) with a responsibility of organizational representation.
- Providing administrative coverage to the sub-ordinate team comprising of 32 staff personnel and 45 technicians/operators.
- Process & equipment troubleshooting, equipment / facility up-gradation & qualification.
- Escorting auditors to the production floor and facing audits (regulatory and clients) with a responsibility of organizational representation in an efficient way & thereby framing appropriate responses and explanations for the observations.
- I was joined the company in production department as a Sr. Manager and promoted within the organization as a Assistant General Manager with tenure of One and half year.
- REPORTING TO VP OPERATIONS: Production, TEAM SIZE HANDLED: 77 nos. (Including staff and technician)
MANAGER PRODUCTION (STERILE BLOCK-PFS LINE)
WOCKHARDT INDIA LTD. SHENDRA (AURANGABAD)
09.2014 - 05.2016
- SMOOTH SETUP OF THE PFS LINE: From initial phase to till release of facility for routine usage.
- INITIAL AND INTERMEDIATE MEDIA FILL SIMULATION:
- Completion of the initial and intermediate media fills simulation of PFS Line for different Pack size.
- Evaluation of the new product with respect to the existing available facility.
- Up gradation of documents and system to meet the cGMP and regulatory requirement.
- Preparation of budget as per the fixed production plan.
- Recruitment of manpower for the department as per the requirements.
- Handled the complex injectable formulation like: Palperidone injection and Resperidone injection etc.
- Designing of the PFS packing machine i.e. Pen Assembly.
- Completed 37 EB batches of the Enoxaparin Injection of multiple strength in 2months. No Major or critical deviation reported.
- REPORTING TO GENERAL MANGER, TEAM SIZE HANDLED: 14 nos. (Including staff and technician)
ASSISTANT MANGER BAND - JM-1
GLAXO SMITH KLINE BEACHEM
10.2013 - 09.2014
- Leading to the Ampoule Manufacturing Block
- Core team member for the remediation activities of Manufacturing Block.
- Tracking of the production plan on day to day basis.
- Participation in Compliance of EHS Policy, HR policy, GSK global policy.
- Implemented the policy of GSK production system , member of the core team member.
- Support to Department in-order to Quality Improvement and cost Reduction
- Up gradation of documentation and timely to meet the regulatory compliance.
- Leading the Deviation, change control, CAPA, Verification observation compliance points.
- Developments of EHS related policies and procedures.
- REPORTING TO GENERAL MANAGER : Production , TEAM SIZE HANDLED: 70 Nos. (Including staff and technician)
Sr. EXECUTIVE PRODUCTION
FRESENIUS KABI ONCOLOGY BADDI Unit-II KISHANPURA
10.2010 - 10.2013
- Led production department in international regulatory inspections like USFDA, ANVISA, WHO-Geneva, Peru, Mexico, MCC and MCAZ.
- I was joined the organization as executive and promoted within the Organization as a Sr. Executive in the tenure of one year.
- Up gradation of cGMP Practices, related documentation and facility to meet the regulatory compliance.
- Responsible for smooth Aseptic operations.
- Responsible for manufacturing and filling operation .
- Transfer of New Products from R&D to Production Unit.
- Participation in the FAT of CIP and SIP System (Make : Neela) , and Isolator (Make : iso kleanzide)
- Over All Compliance of the Japanese Product requirement.
- Conversion of off-line manual packaging activities into an integrated andautomated operation thereby achieving a significant reduction in time and cost.
- Handling of Quality Tools : Deviation , Change control ,CAPA
- Preparation of the BMR, BFR, SOP & PROTOCOLS etc.
- Handling of Online Documentation systems, DCS, EMS, ACCESS MONITROING, cRABS SCADA etc.
MANAGEMENT STAFF
CIPLA LTD. INDORE UNIT-III STERILE BLOCK
03.2009 - 10.2010
- Setup of the Pre filled syringe line (Make : M/s Optima German Line )
- Water system qualification (Pre-treatment plant set up , purified water generation plant set up, water for injection generation plant set up and Qualification)
- Performed Moist heat sterilizer and terminal sterilization set up and qualification (Make : M/s Fedegari)
- Qualification of following new equipment’s which includes the preparation of document and execution of the prepared documents :
- Manufacturing Tank , Holding vessel , Mobile CIP/SIP Unit ,Moist Heat sterilizer
- Filling Machine ,Depyrogenation tunnel ,Labeling Machine ,Blister Packaging Machine , Inkjet Printing unit , Sealing Machine ,Online and off line Particle Counter .
IN CHARGE OF MANUFACTURING ACTIVITY
SUN PHARMACEUTICAL LTD HALOL, GUJARAT
09.2007 - 03.2009
- I was selected to the company as Sr. officer and responsible for the core manufacturing activity, being manufacturing personnel I was responsible for the manufacturing and filling process approx. 20 technicians and 05 officers are directly reporting to me.
- Efficiently handled & utilized 20 workers to meet Minimum & stretched production targets.
- Hands on experience of insulin products & ophthalmic products manufacturing & Lyophilizer operation.
- Handled Ampoule, vial (liquid as well as lyophilized), pre-sterilized plastic bottle aseptic filling operations.
- PRODUCT HANDLED :
- INJECTABLE: Amifostine injection, Lupride injection, Octreotide injection, Pantoprazole lyo injection , HUMAN INSULIN: Different range of Human insulin 30/70, 50/50, Regular, NPH etc.
- OPTHALMIC PRODUCTS: Ketlur eye drop, Ofloxacin eye drop, Latanoprost, eye drop, Miliflox eye drop etc.
- COMPLEX PRODUCTS : Manufacturing of the Amphotericin Injection (Liposomal product )
EXECUTIVE PRODUCTION OPTHALMIC DEPARTMENT
NICHOLAS PIRAMAL INDIA LTD INDORE
06.2005 - 09.2007
- Selected to the organization as executive in ophthalmic department and responsible for the smooth operation of the production in three shift (shift in-charge)
- Daily work allocation to permanent and contractual worker.
- I was initially assigned the job of the ophthalmic packaging line and then looking at my performance they transferred me to core manufacturing area where I was responsible and directly involved in the manufacturing of following types of the product
- Clear solution manufacturing
- Clear solution manufacturing
- Suspension manufacturing
- Clear with on line Filling
- Contact lens Solution (For AMO )
- Exposure of validation activity related to manufacturing and filling :
- Autoclave validation and Qualification (Machine fabric)
- Area qualification
- Cleaning validation
- Exposure for HVAC system and qualification
- Individual operation of Form Fills Sealing machine and qualification and setup, well known and operated the machine many time in absence of the Operators.
Education
MS - Pharmaceutical Technology
Arrihant college and research center Indore
Indore, M.P.01.2010
Bachelor - Pharmacy
SCOPE Indore
Indore, M.P.01.2004
H.S.S.C. - undefined
S.H.S. School
Satna, M.P.01.1999
H.S.C. - undefined
01.1997
Skills
- Pharmaceutical manufacturing expertise
- Technical project management
- Knowledge of QMS systems
- Sterile equipment commissioning and qualification
- Project management
Accomplishments
- Completed Infarmed (Purtgal) audit with minor observation from 09 Dec. 2024 to 17 Dec. 2024
- Successfully completed USFDA audit from 06 Jun 22 to 13 Jun 22 , Appreciated by the USFDA Auditor (M/s Cynthia and Mr. Wyne Macgrath) for demonstration of Man and Material movement and Aseptic setup of the machine . Received the EIR.
- Successfully completed the EU Audit from 24 Aug 2022 to 30th Aug 2022 , appreciated by the EU auditor for the demonstration of the In-process checks of Vial Line. (Eva Maria and Gargely Tasi )
- APPRECIATED BY THE NSF (US Consultant) during the NSF Consultant Phase-1assessment of the facilityand personnel, recommended for the promotion. (Promoted in the same year from Sr. Manager to AGM )
- Demonstrated the man-material movement, QMS of the Independent PFS block to US Inspectors and caught the appreciation. (Wockhardt India pvt. Ltd. Shendra)
- Successfully completed the installation and operational qualification and setup of the Liquid and Dry powder filling line for the General Products.
- Successfully lead the installation and operation qualification of the manufacturing and filling vessel and fixed process pipelines -M/s Praj Hi Purity system.
- Initiated the Process simulation activity of the Liquid products.
- Completed the Remediation of the General Block –Liquid line and executed the Exhibit batches for sterile operations.
- FAT of the following machine: Liquid vial inspection – M/s Bosch Inspection machine – Japan, Part washer –Steelco –Italy , Filling and closing Machine –M/s Groninger –Germany –Frankfurt.
- Participated in Global Akornian production summit of US Illinois/ Decatur represented the Akorn India Plant.
- APPRECIATED BY THE PWC Consultant for the development of the aseptic area and good aseptic practices. Recommended by the PWC Consultant to lead the Aseptic Operations.
- Enhance the production output from 2.50 lacks to 3.0 lacks monthly from one line. (M/s Fresenius Kabi Oncology Baddi Unit-II)
- Completed PFS Line qualification project in M/s Wockhardt India pvt. Ltd. , successfully completed the process simulation activity in the same line. (Total 7 nos. of the media batches passed in single attempt )
Timeline
DEPUTY GENERAL MANAGER
LUPIN BIOTECH – PUNE
05.2025 - Current
Deputy General Manager-Production
AUROBINDO PHARMA UNIT-XII BACHUPALLY (HYDERABAD)
11.2023 - 03.2025
General Manager Production
Shilpa Medicare Limited (Unit -IV)
01.2023 - 10.2023
General Manager Production
Immacule life-science Pvt. Ltd
01.2022 - 01.2023
ASSISTANT GENERAL MANAGER –OPERATIONS
BIOLOGICAL EVANS PVT. LTD. (FORMELY KNOW AS AKORN INDIA PVT. LTD.)
05.2016 - 05.2021
MANAGER PRODUCTION (STERILE BLOCK-PFS LINE)
WOCKHARDT INDIA LTD. SHENDRA (AURANGABAD)
09.2014 - 05.2016
ASSISTANT MANGER BAND - JM-1
GLAXO SMITH KLINE BEACHEM
10.2013 - 09.2014
Sr. EXECUTIVE PRODUCTION
FRESENIUS KABI ONCOLOGY BADDI Unit-II KISHANPURA
10.2010 - 10.2013
MANAGEMENT STAFF
CIPLA LTD. INDORE UNIT-III STERILE BLOCK
03.2009 - 10.2010
IN CHARGE OF MANUFACTURING ACTIVITY
SUN PHARMACEUTICAL LTD HALOL, GUJARAT
09.2007 - 03.2009
EXECUTIVE PRODUCTION OPTHALMIC DEPARTMENT
NICHOLAS PIRAMAL INDIA LTD INDORE
06.2005 - 09.2007
Indoco remedies GOA -Unit-III
Bachelor - Pharmacy
SCOPE Indore
H.S.S.C. - undefined
S.H.S. School
H.S.C. - undefined
MS - Pharmaceutical Technology
Arrihant college and research center Indore
Disclaimer
I hereby declare that the information given above is true to the best of my knowledge. Manoj Tripathi
5.0 REGULATORY AUDIT FACED
- Regulatory Body Name: Infarmed (Purtgal)
- No. of times Exposed: 01
- Role: Direct Demonstration to Auditor for Aseptic area and Manufacturing Area
- Organization Name: Eugia Pharma Unit-III SEZ (Parshyamlarma)
- Regulatory Body Name: EU Audit (Hungery)
- Role: Direct Demonstration of the Man and Material Movement and Product Process.
- Organization Name: Immacule Life science Pvt. Ltd. Auditor Name : Mrs. Eva Maria and Mr. Gargely Tasi .
- Regulatory Body Name: USFDA
- Role: Direct Demonstration to USFDA Auditor for Man and Material movement, Aseptic Assembling, Aseptic setup.
- Organization Name: Immacule Life science Pvt. Ltd. Auditor Name : Mr. Cynthia and Mr. Wayne Macgrath. Date : 06 / Jun/22 to 13/Jun/22
- Role: Direct Demonstration to Auditor – Man –Material Movement & QMS of the PFS Block
- Organization Name: Wockhardt India pvt. Ltd. Shendra Aurangabad (Maharastra) Auditor Name : Mr. Dipesh shah Mr. Danish
- Regulatory Body Name: MHRA
- No. of times Exposed: 03
- Organization Name: Fresenius Kabi Oncology ltd. Baddi – Himachal Pradesh
- No. of times Exposed: 02
- Role:
- Organization Name:
- Regulatory Body Name: ANVISA
- Regulatory Body Name: JAPAN
- Regulatory Body Name: UGANDA
- Regulatory Body Name: MIP / FKOL / Internal audit / Local audit
- No. of times Exposed: 06
- Role: Direct Demonstration
- Organization Name: Sun Pharmaceutical Halol -Gujarat
- Regulatory Body Name: WHO
- Organization Name: Cipla Ltd Indore – Madhya Pradesh
- Regulatory Body Name: MCC
- Role: Preparatory work
- Organization Name: Nicholas Piramal ltd Indore- Madhya Pradesh
- Regulatory Body Name: Allergan
- CONSULTANT AUDITS
- NSF
- All Phases
- Direct Demonstration
- Appreciated by the NSF for good demonstration in Akorn india pvt. ltd. Paonta Sahib – Himachal Pradesh
- PWC
- Once
- Appreciated by the PWC and recommended to have the similar kind of demonstration in front of USFDA in Akorn india pvt. Ltd. Paonta Sahib – Himachal Pradesh
7.0 EXTRA CURRICULAR ACTIVITIES
Active Member of M.P. Pharma Meet 2002&2003&2004 Pawan Jyoti Award in1997 Pre senior union information test 1994 SAP system Exposure Received the computer system application and software validation Actively involved in ZAP reporting system , EHS policy Implementation Knowledge of basic of computer, M.S. Word & internet ERP system exposure
PROJECTS
Projects Title: “Pre Filled Syringes Technology and Over View”, University /Organization: VMS University Salem Tamil Nadu/Arihant College Indore, Year: 2010, Projects Title: “Plant tissue culture and Overview”, University /Organization: Smriti college of Pharmaceutical Education Indore, Year: 2004