SHIJU KOOTTALA BABY
Manager – Quality Systems And Compliance
Singapore
Summary
To achieve a professionally competitive position in the world of Pharmaceutical Sector.
Overview
15
15
years of professional experience
1
1
Certification
Work History
Manager – Quality Systems and Compliance
MSD International GmBH
2 2021
- Currently working as Manager Quality System and Compliance in charge of Document control Team consists of 11 members in charge of document management for Singapore Site
- Also in charge of implementation of Global guidelines in Standard Operating procedure (SOP) on Site
- Manage all GMP records generated at Site
- Acts as RIM (Records and Information Management) Liaison Officer
- Implement Global guidelines
Production Lead / Operation Support Lead
MSD International GmBH
- Participated in the commissioning and qualification of equipment and facility
- Management of Team of 24 technicians
- Maintain safety, quality and compliance standards as per Corporate and regulatory standards
- Work in co-ordination with other support functions including QA, GTO, EHS and Engineering
- Implementation of WCS (World Class Supplier) project in Janumet manufacturing Facility
- Part of capacity improvement program for Janumet from 24 Bxs to 39 bxs per week with a peak of 45 Bxs
- Reduction of Granulation CT and granulation Cleaning CT
- Introduction of e-Shopfloor to reduce use of HC forms on shop floor.
Production Pharmacist
Variety Pharmaceuticals Ltd & Variety Formulations Ltd
- Assist production manager on the daily activities
- Supervising the formulation and packaging activities involved in the sterile preparation
- Ensure the operators follow procedure as per SOP's
- Maintaining the daily log for the tractability of all manufacturing process
- Prepare/review Batch Manufacturing Records
- Perform the process and cleaning validation as per the protocol
- Coordinate with the QA/QC department for the validation of the product and investigation on product failures.
Production Pharmacist & R&D in Charge
Sunward Pharmaceutical Sdn Bhd
02.2008 - 03.2013
- Total management of different production departments from formulation to packaging (Granulation/Tabletting/Film /Sugar Coating/Packing)
- Control and monitoring of manufacturing process effectively in accordance with cGMP and in-house standards
- Ensure in-process and finished products meet the QA/QC standards
- Review the manufacturing process documents like Batch Manufacturing Records, SOP’s, and Deviation control documents etc
- As per SOP and regulatory standards
- Provide support for the qualification of manufacturing equipments
- Preparation of SOP’s related to the manufacturing process
- Provide guidance and training production staffs in accordance with SOP’s
- Monitoring the effective implementation of change control recommendations
- Monitor the performance of production staff
- Supervise the production scheduling and ensures that the targets are meets in time
- Analysis of daily achievement of Production targets and coordinate with other departments if there is a change in schedule
- Prepare for the regulatory audit and participant in internal audit program and implement recommendations
- Coordinate closely with QA on the investigation on manufacturing process deviations and product failures
- Coordinate with QA for the qualification or re qualification of machineries
- Assist in process validations and cleaning validations.
Pharmacist in Charge
Ustra Pharma Limited
06.2006 - 12.2008
- Import of drugs and surgical products
- Registration of new products with Pharmacy Board of Malawi
- Maintenance of distribution records
- Maintenance of warehouse as per the regulations of the Pharmacy Board
- Marketing products
- Introduction of new products in Malawi
- Preparation of bidding documents for GOVT/ Private tenders
- Dealing with suppliers and customers
- Arrange inspection from the Pharmacy Board on the manufacturing sites.
Pharmacist Production
Sance Laboratories Pvt Ltd
09.2004 - 06.2006
- To give proper inputs for the design of the plant
- To find out suitable machineries fro the manufacturing of Tablets, Capsules, Dry Syrups and Dry powder injectables
- To do the Factory Acceptance test for the machineries
- To look after various civil/electrical activities are done according to the design and specifications and their documentation
- Preparation of deviation report and its documentation
- Preparation of design qualification for various machines with the Maintenance dept
- Prepare IQ and OQ for above machines
- Prepare relevant SOP’s, its training and implementation
- Commissioning of the machineries
- Preparation of trial batches and its documentation
- Monitoring the performance of the Supervisors and other production staffs
- Prepare production scheduling and ensure that the targets are achieved in time
- Prepare plant for various regulatory audits
- Participate in internal and external audits and implement and follow up the recommendations
- Coordinate with QA to prepare PQ for the machineries
- Conduct internal audits in QA, QC, Maintenance, Warehouse and Administration.
Production Manager
Vysali Pharmaceuticals Limited
08.1998 - 09.2004
- Organize the daily activities in the plant according to the production scheduling
- Preparation and revision of SOP’s as per the requirement and train the staff accordingly and document the same
- Review of BMR/BPR used in the formulation department
- Ensure in-process and finished products meet the internal and regulatory standards
- Trouble shooting in the manufacturing process and review/prepare the deviation reports
- Provide guidance and support fro qualification of manufacturing equipments
- Preparation/Review and execution of Protocols for process validation and cleaning validation
- Prepare/review change control documents and prepare effective recommendations and its execution
- Monitor and evaluate the performance of the supervisors and other production staffs.
Education
Bachelor of Pharmacy (B Pharm) -
University of Mysore
Bachelor of Pharmacy (B Pharm) - undefined
University of Mysore
Skills
process and equipment qualification
Manufacturing operations
Operations Management
Personnelprofile
I introduce myself as one of the experienced professionals in the Pharmaceutical Industry with a wide range of experience in Manufacturing and Marketing since 1995. I have proved myself to be self-motivated, committed, and determined in achieving my goals. I use my managerial as well as interpersonal skills to achieve these goals. I have also demonstrated my organizing skills, firm sense of responsibility, and my capacity to work under pressure. I possess good verbal and written communication skills.
Personalparticulars
47, 03/26/74, Indian, Male, Married
Accomplishments
- Achieved [Result] by introducing [Software] for [Type] tasks.
Languages
English
Bilingual or Proficient (C2)
Hindi
Intermediate (B1)
Malayalam
Upper intermediate (B2)
Certification
Licensed [Job Title] - [Timeframe]
Interests
Pets
Cricket
Used to play cricket in schools and college.
Timeline
Production Pharmacist & R&D in Charge
Sunward Pharmaceutical Sdn Bhd
02.2008 - 03.2013
Pharmacist in Charge
Ustra Pharma Limited
06.2006 - 12.2008
Pharmacist Production
Sance Laboratories Pvt Ltd
09.2004 - 06.2006
Production Manager
Vysali Pharmaceuticals Limited
08.1998 - 09.2004
Manager – Quality Systems and Compliance
MSD International GmBH
2 2021
Production Lead / Operation Support Lead
MSD International GmBH
Production Pharmacist
Variety Pharmaceuticals Ltd & Variety Formulations Ltd
Bachelor of Pharmacy (B Pharm) -
University of Mysore
Bachelor of Pharmacy (B Pharm) - undefined
University of Mysore
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