ROBIN DEY

Summary of Qualification: 

• Having working experience in FDA, GCC, ANVISA, AGES, and TGA-approved pharmaceutical companies.
• More than 5 years experience in computer application and Proficient in MS Word, Excel, PowerPoint, and the Internet.
• Having lean training that gives the knowledge of how to use resources and minimize waste and inventory.
• Strong ability to work under pressure and a quick learner.
• Excellent interpersonal, communication, and customer service skills.
• Dedicated to always maintaining the highest levels of service.
• Excellent verbal and written communication skills.
• Having an experience in Symex methodologies.

Professional Experience:

Job Title: Strategic Sourcing Associate, Clinical Capital

Period: Sep 2022- present

Organization: Shared Services West, Northgate Business Park, 1107 Clay Avenue, Unit 500|Burlington| ON | L7L 0A1

Major Job Responsibilities: 

 Manage procurement process to effectively purchase equipment, products, and services at the best overall cost, consistent with satisfactory performance, quality, and service.

 Develop and issue RFx documentation of basic to mid-level procurements based on customer requirements.

 Proactively meet with end-users to review approved equipment requests and upcoming contract expirations.

 Manage contract negotiations, amendments, and extensions in a timely manner.

 Gather and analyze supplier data and information to perform simple financial analysis and determine best value opportunities.

 Ensure that business relations with suppliers are conducted according to the ethical guidelines and BPSPD directives.

 Manage transactions for equipment, product supply, and service agreements, including monitoring compliance with terms and conditions.

 Review equipment specifications and service requirements with customer groups through meetings and ongoing communication with suppliers to achieve the best product and service value (cost, quality, delivery, warranty).

 Provide timely communication of project status with internal and external customers and escalate issues as appropriate.

 Develop and maintain strong customer relationships.

 Coordinate and facilitate evaluations/ trials when required.

 Maintain adequate department coverage to ensure departmental standards are upheld.

 Lead and coordinate project activities as required.

Job Title: Production Technician

Period: Mar 2013 – Sep 2022

Organization   : Contract Pharmaceuticals Ltd; 7600 Danbro Crescent, Mississauga ON L5N 6L6

Major Job Responsibilities:

• Preparing any types of customer requirements and validation samples according to the protocol.
• Taking responsibility and accountability for the execution of validation protocols including the collection of samples, coordination of testing, and coordination of third-party services.
• Assist in the planning of validation program schedules.
• Ensuring specific equipment and the process will consistently produce a product meeting predetermined specifications and attributes.
• Make suggestions on current SOPs as required.
• Checking that cross-contamination or bacterial contamination does not occur during the manufacturing and packaging process.
• Assisting in assembly and set-up of manufacturing equipment.
• Assisting and maintaining safe and healthy working conditions during the manufacturing of bulk products.
• Ensuring the new trainees can get the proper training and information on how to work safely and healthily in a GMP environment.
• Performed and experienced in manufacturing the product in presence of the internal and external customers.
• Recording the observations and process characteristics during making product development, customer, and validation batches.
• Having good knowledge of basic processes and equipment used in product and process development. 
• Review the manufacturing work order to ensure the whole process meets all specifications.
• Ensures that all work is performed in compliance with the required applicable SOPs, cGMP, and established Safe Work Practices (SWP).

Achievements:

• Outstanding ability to prioritize and juggle multiple tasks.
• Exposure to Manufacturing Equipment. Such as Murzan pump, Silverson pump, Silverson Inline mixer, Quadro-Ytron equipment, Micro fluidizer, Graco pump, Vacuum De-aerator, Gaulin mill, BDC Stirrer,Olsa Kettle, Symex Kettle.

Job Title: Industrial pharmacist (Quality Assurance Pharmacist)

Period: May 2009 - Feb 2013

Organization: Beximco Pharmaceuticals Limited, Tongi, Gazipur, Bangladesh. 

Major Job Responsibilities:

1. Checking the area’s cleanliness during packaging operation which includes blistering, cartooning, labeling, and shipping.

2.  Ensuring the release of the final product to the export market after reviewing and compilation of the batch record.

3.  Preparation of certificate of analysis (COA) for routine and registration purposes for export.

4.  Releasing the quality control report after reviewing the data and results.

5. Communicate with the quality control department to get the report of the product to release in the commercial market.

6. Communicate with the manager about the problem identification in the product.

7. Maintaining proper documentation of Batch production records, quality checking records, and retention samples.

8. Ensure the batch manufacturing record, batch packaging record, and quality control report are compiled together to release the product in the commercial and export markets.

9. Maintain and retain the batch record and retention sample as per the guideline.

10. Entry the retention sample into the log to rectify the expired retention sample.

11. Ensuring the corrective and preventive actions (CAPA) identifying, implementing, and remedying timely.

12. Carry out the quality check of drug products in every stage of manufacturing

13. Performing the proper dispensing of raw materials by evaluating the proper labeling of pass tags and dispensing of accurate quantity.

14. Operating the in-process instruments like weight balance, hardness, thickness and diameter tester, disintegration, friability, and leak tester.

15. Maintaining the validation activities to validate the Batch manufacturing and packing procedure

16. Handling the deviation report, write-off form, TIS (Technical Information Sheet), QA observation report, and problem notification form during in process.

Achievements:

• Adapted quickly to a fast-paced and demanding industrial environment.
• Demonstrated good problem-solving skills in pharmacology.
• Exposure to Manufacturing Equipment. Such as-

Compression Machine- Manesty(16 and 35 station), Sejong(49 & 51 station), Fette1200(30 and 55 station), Encapsulation Machine- MG2, Coating Machine- Accelacota, Pamglatt, Powder filling Machine for suspension, Fluid bed dryer. Packaging Machine- Hoonga, Hemson and Ganson Strip packing machine, Tien Tuan machine.

Educational Qualifications:

MS in Pharmaceutical Technology-University of Asia Pacific, Dhaka

Bachelor of Pharmacy- University of Science and Technology, Chittagong.

Pursued courses in Pharmaceutical Quality Assurance and Basics and English at Seneca College.

Certificate from the Coursera- Better Business Writing in English

References:

References are available upon request.

Major Job Responsibilities:

• Preparing any types of customer requirements and validation samples according to the protocol.
• Taking responsibility and accountability for the execution of validation protocols including the collection of samples, coordination of testing, and coordination of third-party services.
• Assist in the planning of validation program schedules.
• Ensuring specific equipment and the process will consistently produce a product meeting predetermined specifications and attributes.
• Make suggestions on current SOPs as required.
• Checking that cross-contamination or bacterial contamination does not occur during the manufacturing and packaging process.
• Assisting in assembly and set-up of manufacturing equipment.
• Assisting and maintaining safe and healthy working conditions during the manufacturing of bulk products.
• Ensuring the new trainees can get the proper training and information on how to work safely and healthily in a GMP environment.
• Performed and experienced in manufacturing the product in presence of the internal and external customers.
• Recording the observations and process characteristics during making product development, customer, and validation batches.
• Having good knowledge of basic processes and equipment used in product and process development. 
• Review the manufacturing work order to ensure the whole process meets all specifications.
• Ensures that all work is performed in compliance with the required applicable SOPs, cGMP, and established Safe Work Practices (SWP).

Achievements:

• Outstanding ability to prioritize and juggle multiple tasks.
• Exposure to Manufacturing Equipment. Such as Murzan pump, Silverson pump, Silverson Inline mixer, Quadro-Ytron equipment, Micro fluidizer, Graco pump, Vacuum De-aerator, Gaulin mill, BDC Stirrer,Olsa Kettle, Symex Kettle.

Educational Qualifications:

MS in Pharmaceutical Technology-University of Asia Pacific, Dhaka

Bachelor of Pharmacy- University of Science and Technology, Chittagong.

Pursued courses in Pharmaceutical Quality Assurance and Basics and English at Seneca College.

Certificate from the Coursera- Better Business Writing in English