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:

• Checking the area’s cleanliness during packaging operation which includes blistering, cartooning, labeling, and shipping.
• Ensuring the release of the final product to the export market after reviewing and compilation of the batch record.
• Preparation of certificate of analysis (COA) for routine and registration purposes for export.
• Releasing the quality control report after reviewing the data and results.
• Communicate with the quality control department to get the report of the product to release in the commercial market.
• Communicate with the manager about the problem identification in the product.
• Maintaining proper documentation of Batch production records, quality checking records, and retention samples.
• 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.
• Maintain and retain the batch record and retention sample as per the guideline.
• Entry the retention sample into the log to rectify the expired retention sample.
• Ensuring the corrective and preventive actions (CAPA) identifying, implementing, and remedying timely.
• Carry out the quality check of drug products in every stage of manufacturing
• Performing the proper dispensing of raw materials by evaluating the proper labeling of pass tags and dispensing of accurate quantity.
• Operating the in-process instruments like weight balance, hardness, thickness and diameter tester, disintegration, friability, and leak tester.
• Maintaining the validation activities to validate the Batch manufacturing and packing procedure
• 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