DEEPAK MALHOTRA
Amritsar
Summary
Experienced Manager in Pharmaceutical Industry specializing in Small Volume Parenteral and Dry Powder production. Improved operational efficiency through effective employee motivation and stringent policy enforcement while ensuring compliance with regulatory standards. Demonstrated leadership in project management and production compliance, contributing to successful outcomes in manufacturing environments.
Overview
16
16
years of professional experience
Work History
Manager Production
Kwality Pharmaceutical Ltd.
10.2024 - Current
- Provide leadership and guidance to ensure leading edge practices are defined and implemented related to regulatory requirements for implementation of Production department (SOP, BMR, Change Control, CAPA, Risk Assessment, Deviation and Incident) and operation of the Lyophilization Equipment
- Qualified Trainer, to train the production personnel on aseptic techniques, policies, SOPs.
- Monitors trends, identifies issues, recommends and implements appropriate actions
- Review Batch Manufacturing Records, Batch Packing Records
- Internal and External Audit compliance
- Support the Validation team on Media Fill Execution and Qualification of Equipment
- Motivating down line team members for completion of all QMS related activities within stipulated time line by creating work healthy atmosphere
- Responsible for successful conducting of Media Fill, identification of interventions, qualification of intervention.
- Product Handling: Propofol Injection and Liposomal Amphotericin B for Injection etc.
Deputy Manager Production
Kwality Pharmaceutical Ltd.
04.2024 - 09.2024
- Provide leadership and guidance to ensure leading edge practices are defined and implemented related to regulatory requirements for implementation of Production department (SOP, BMR, Change Control, CAPA, Risk Assessment, Deviation and Incident) and operation of the Lyophilization Equipment
- Qualified Trainer, to train the production personnel on aseptic techniques, policies, SOPs.
- Monitors trends, identifies issues, recommends and implements appropriate actions
- Review Batch Manufacturing Records, Batch Packing Records
- Internal and External Audit compliance
- Support the Validation team on Media Fill Execution and Qualification of Equipment
- Preparation and Review of URS.
- Motivating down line team members for completion of all QMS related activities within stipulated time line by creating work healthy atmosphere
- Responsible for successful conducting of Media Fill, identification of interventions, qualification of intervention.
Asst. Manager Production
Eugia Pharma Specialities Ltd. (Unit of Aurobindo Pharma Ltd.)
05.2020 - 03.2024
- Provide leadership and guidance to ensure leading edge practices are defined and implemented related to regulatory requirements for implementation of Production department (SOP, BMR, Change Control, CAPA, Risk Assessment, Deviation and Incident) and operation of the Lyophilization Equipment
- Qualified Trainer, to train the production personnel on aseptic techniques, policies, SOPs.
- Monitors trends, identifies issues, recommends and implements appropriate actions
- Review Batch Manufacturing Records, Batch Packing Records
- Internal and External Audit compliance
- Support the Validation team on Media Fill Execution and Qualification of Equipment
- Motivating down line team members for completion of all QMS related activities within stipulated time line by creating work healthy atmosphere
- Responsible for successful conducting of Media Fill, identification of interventions, qualification of intervention.
- Product Handling: Ertapenem for Injection
Team Leader
Dr. Reddys Ltd., FTO-6, Baddi, H.P
12.2017 - 03.2020
- In charge of unit preparation area – Liquid vial & ampoule Line
- Manufacturing Planning, Qualification planning and execution within stipulated timeline
- Qualified Trainer, to train the production personnel on aseptic techniques, policies, SOPs.
- Production QMS (SOP, BMR, Change Control, CAPA, Risk Assessment, Deviation and Incident).
- Motivating down line team members for completion of all production and QMS related activities within stipulated timeline by creating work healthy atmosphere.
- Responsible for successful conducting of Media Fill, identification of interventions, qualification of intervention.
- Product Handling: Omeprazole for Injection and Ketorolac injection etc.
- Reporting to: Resource Leader Production
- Team SizeHandled: Approx.15 persons.
Sr. Officer
Fresenius-Kabi Oncology Limited, Baddi, H.P
10.2016 - 12.2017
- BMR preparation
- Production QMS (Preparation of SOP and BMR)
- Support Validation Team for qualification of equipment/ Instruments
- Unit Preparation area, Solution Preparation
- Internal Audit
- Reporting to: Manager Production
- Team Size Handled: Approx.10 persons.
Executive
Immacule Lifesciences Ltd., Nalagarh, H.P.
02.2014 - 09.2016
- Shift In-charge: Liquid vial & ampoule Line
- Production QMS (SOP, BMR, Change Control, CAPA, Risk Assessment, Deviation and Incident).
- Support Validation Team for qualification of equipment/ Instruments
- Reporting to: Manager Production
- Team Size Handled: Approx.20 persons.
Officer
Psychotropic India Ltd., Haridwar, Uttarakhand
07.2010 - 01.2014
- Operated vial washing equipment in sterile environment.
- Executed sterilization procedures to ensure safety and compliance.
- Formulated solutions according to established guidelines.
- Conducted filling and sealing of products in compliance with standards.
- Executed dry powder injections to ensure effective delivery.
- Reported directly to Assistant Manager for operational updates.
- Managed a team of around 10 members to achieve project goals.
Education
B.Pharma -
Doaba College of Pharmacy
Mohali01-2010
Master of Science - Medicinal And Pharmaceutical Chemistry
Ram Gopal College of Pharmacy, Gurugram
Rohtak, India 04.2001 -
Skills
Injectable products
Lyophilization
Regulatory compliance
Aseptic techniques
Media fill execution
Production oversight
Process validation
Training and development
Consultative problem solving
Cross-functional communication
Collaborative teamwork
Effective communication
Accomplishments
FDA APPROVAL: APPROVED BY FDA OF Approved Chemist under Himachal Pradesh FDA “MANUFACTURING SMALL VOLUME PARENTERALS”
Timeline
Manager Production
Kwality Pharmaceutical Ltd.
10.2024 - Current
Deputy Manager Production
Kwality Pharmaceutical Ltd.
04.2024 - 09.2024
Asst. Manager Production
Eugia Pharma Specialities Ltd. (Unit of Aurobindo Pharma Ltd.)
05.2020 - 03.2024
Team Leader
Dr. Reddys Ltd., FTO-6, Baddi, H.P
12.2017 - 03.2020
Sr. Officer
Fresenius-Kabi Oncology Limited, Baddi, H.P
10.2016 - 12.2017
Executive
Immacule Lifesciences Ltd., Nalagarh, H.P.
02.2014 - 09.2016
Officer
Psychotropic India Ltd., Haridwar, Uttarakhand
07.2010 - 01.2014
Master of Science - Medicinal And Pharmaceutical Chemistry
Ram Gopal College of Pharmacy, Gurugram
04.2001 -
B.Pharma -
Doaba College of Pharmacy
PERSONAL SNAPSHOT
DATE OF BIRTH: 20 FEBRUARY 1986 GENDER: MALE FATHER’S NAME: KHAIRATI LAL MARITAL STATUS: MARRIED PERMANENT ADDRESS: H.NO. I-4B, 2nd FLOOR, NEW GOBIND PURA EXT., BEDI MARKET, CHANDER NAGAR, DELHI-110051. I VOUCH THE AUTHENTICITY OF THE STATEMENT. DATE: Yours faithfully, (Deepak Malhotra)
NOTEWORTHY CREDENTIALS
- Instrumental in clearing the audits conducted by the following authorities
- Kwality Pharmaceutical Ltd.: COLOMBIA, ANVISA, EU-GMP
- Eugia Pharma Specialities Ltd.: EU GMP
- Dr. Reddys Ltd.: RUSSIA, EU-GMP, COLOMBIA
- Fresenius-Kabi Oncology Limited,: EU-GMP
- Immacule Lifesciences Ltd.: EU-GMP, COLOMBIA
- Psychotropic India Ltd.: EMCURE, PFIZER