GHANSHYAM PATEL
Calgary,Canada
Summary
Results-driven and detail-oriented Quality Assurance professional with over 20 years of experience in the pharmaceutical industry. Well-versed in good manufacturing practices and knowledgeable about Canadian cGMP and FDA requirements. Demonstrated exceptional communication, self-motivation, and target-oriented skills while performing all duties and responsibilities. Thrived in a fast-paced environment, exhibiting strong interpersonal and leadership abilities, and excelled with minimal supervision. Proficient in various computer software programs, including MS Word, Excel, Outlook Web, ERP, and SAP. Skilled in documentation management, including electronic Quality Management Systems. Recognized for maintaining high standards and achieving consistent results. Proven track record of identifying and resolving quality issues to uphold top-tier product standards. A reliable team player focused on collaboration and adapting to evolving project needs. Expertise in quality control processes and meticulous analysis.
Overview
21
21
years of professional experience
Work History
Quality Assurance Specialist
Bausch Health Companies
01.2018 - 09.2021
- Facilitates release of finished products to international market (i.e., Canadian market, US market, European market etc.) by reviewing product compliance and preparing various certificates and documents such as certificate of Analysis and certificate of manufacture
- Review and evaluation of GMP documentation and QC test reports to determine disposition of in-process material, bulk material and packaged products
- Conduct Investigation to resolve discrepancies and error in collaboration with other operational areas in a timely manner ensuring appropriate actions are taken
- Review, evaluation and maintenance of various Quality systems including compilation of department metrics according to key performance indicators
- Write and revise Standard Operation Procedures to ensure compliance
- Compilation of Annual Product Quality Review information on various quality system
- Support regulatory inspections and Audits
- Support the management of Contract Manufacturing Operations to ensure CMOs are following approved Quality Agreements, SOPs and Regulations
- Ensure compliance to current good manufacturing practices, Regulatory requirement and Occupational health & safety
- Provide change control support by documenting changes, reducing chances of unauthorized activities
- Provide continuous support to manufacturing department for any quality related issues
- Initiate and follow up reject notifications of rejected or returned pharmaceuticals products and packaging materials
Production Operator II / Designate
Elys Chemical Industries (U) ltd
09.2011 - 07.2017
- Six years of experience in pharmaceutical manufacturing in a GMP and quality assurance regulated environment
- Ensure that GMP and quality assurance protocols are being applied or implemented constantly while supervising team of pharmaceutical manufacturing employees
- Performed inspection and approval of manufacturing line on daily basis to ensure standard operating procedure are being followed
- Performed inspection and approval of materials and pharmaceuticals products being manufactured to ensure standard and specifications are consistently met
- Participated in product related investigation to resolve problems and issues in the manufacturing area
- Prepared written recommendations for improvements in manufacturing practices after inspection and/or investigation in the manufacturing area had been conducted
- Coordinate team activities in dispensing department through effective communication and diligent record review, ensuring correct batch records are being dispensed in accordance to schedule, priorities and needs
Pharmacy Technician
Karuri Pharmaceuticals ltd
07.2000 - 08.2011
- Receiving prescriptions from patients and verifying all information
- Preparing labels for prescriptions as per doctor’s instruction before pharmacist dispense
- Carrying out technical and clerical duties related to the receipt and recording of prescriptions
- Performing a full range of pharmacy technician procedures
- Taking inventory of stock and entering orders into database
- Keeping appropriate, accurate and up to date records and documentation
- Working hand to hand with other health care professionals in professional manner
Education
Diploma -
Computerized Business System
Bachelor of Science - Chemistry
Gujarat University
India05-1997
Skills
- Good manufacturing practices
- Quality Assurance
- Canadian cGMP
- FDA requirements
- Communication
- Self-motivation
- Target oriented
- Interpersonal skills
- Leadership skills
- Ability to work under minimum supervision
- Computer software programs
- MS Word
- Excel
- Outlook web
- ERP
- SAP
- Documentation management
- Electronic Quality management systems
Relatedtraining
- Quality assurance and good manufacturing practices (cGMP) workshops, 2018-2021, Bausch Health Canada
- GMP Principle for Batch Records and Adverse Event Reporting, 2020, Bausch Health Canada
Languages
English
Professional Working
Punjabi
Limited Working
Timeline
Quality Assurance Specialist
Bausch Health Companies
01.2018 - 09.2021
Production Operator II / Designate
Elys Chemical Industries (U) ltd
09.2011 - 07.2017
Pharmacy Technician
Karuri Pharmaceuticals ltd
07.2000 - 08.2011
Diploma -
Computerized Business System
Bachelor of Science - Chemistry
Gujarat University
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