227 Assurance Specialist jobs in Vietnam
Pharmaceutical Quality Assurance Specialist
Posted today
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Job Description
Key Responsibilities:
- Review and approve batch records, validation protocols, and other quality-related documentation.
- Ensure adherence to Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and other relevant regulatory standards.
- Conduct internal audits and inspections to assess compliance with quality systems.
- Investigate deviations, non-conformances, and out-of-specification (OOS) results.
- Develop and implement corrective and preventive actions (CAPAs) to address quality issues.
- Participate in regulatory inspections and audits from health authorities.
- Assist in the development and maintenance of Standard Operating Procedures (SOPs).
- Monitor and evaluate the performance of quality control processes.
- Collaborate with R&D, manufacturing, and other departments to ensure quality integration.
- Stay updated on pharmaceutical regulations and quality best practices.
- Contribute to the continuous improvement of the Quality Management System.
- Manage and maintain quality documentation and records.
- Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science field.
- Minimum of 3-5 years of experience in Quality Assurance or Quality Control within the pharmaceutical industry.
- In-depth knowledge of GMP, GLP, and other relevant pharmaceutical regulations.
- Experience with quality management systems and documentation practices.
- Strong analytical and problem-solving skills.
- Excellent attention to detail and organizational abilities.
- Proficiency in Microsoft Office Suite and familiarity with electronic document management systems.
- Effective written and verbal communication skills.
- Ability to work independently and manage multiple tasks concurrently.
- Experience with audits and regulatory inspections is a plus.
Pharmaceutical Quality Assurance Specialist
Posted today
Job Viewed
Job Description
Pharmaceutical Quality Assurance Specialist
Posted today
Job Viewed
Job Description
Responsibilities:
- Implement and maintain the company's Quality Management System (QMS) in accordance with relevant regulations.
- Review and approve batch records, deviations, and change controls.
- Conduct internal audits and support external audits by regulatory agencies and customers.
- Ensure compliance with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and other applicable quality standards.
- Monitor and evaluate manufacturing processes to ensure product quality and consistency.
- Investigate deviations, out-of-specification (OOS) results, and customer complaints, implementing corrective and preventive actions (CAPAs).
- Develop and maintain Standard Operating Procedures (SOPs) and other quality-related documentation.
- Participate in validation activities for equipment, processes, and analytical methods.
- Train personnel on quality procedures and GMP requirements.
- Release finished products for distribution after verifying compliance with all specifications.
- Analyze quality data and identify trends, recommending improvements to processes and systems.
- Collaborate with production, R&D, and regulatory affairs departments to ensure quality objectives are met.
- Stay updated on current pharmaceutical regulations and industry best practices.
- Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific field.
- Minimum of 4 years of experience in Quality Assurance or Quality Control within the pharmaceutical industry.
- In-depth knowledge of GMP, FDA regulations, and ICH guidelines.
- Experience with QMS, deviation management, change control, and CAPA systems.
- Strong analytical and problem-solving skills.
- Excellent attention to detail and accuracy.
- Proficiency in Microsoft Office Suite and quality management software.
- Strong written and verbal communication skills.
- Ability to work effectively both independently and as part of a team.
- Experience with validation processes is a plus.
- Good understanding of pharmaceutical manufacturing processes.
Pharmaceutical Quality Assurance Specialist
Posted today
Job Viewed
Job Description
Responsibilities:
- Develop, implement, and maintain Quality Management Systems (QMS) for pharmaceutical manufacturing.
- Ensure compliance with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and other relevant regulatory guidelines.
- Review and approve batch records, analytical data, and other quality-related documentation.
- Conduct internal audits and inspections to assess compliance with quality standards.
- Investigate deviations, out-of-specification (OOS) results, and customer complaints, implementing corrective and preventive actions (CAPAs).
- Participate in external audits from regulatory agencies and customers.
- Monitor and analyze quality control data to identify trends and areas for improvement.
- Collaborate with manufacturing, R&D, and other departments to ensure quality is integrated into all stages of product lifecycle.
- Develop and deliver training programs on quality assurance principles and practices for staff.
- Manage and maintain quality control equipment calibration and validation schedules.
- Write and revise Standard Operating Procedures (SOPs) and quality policies.
- Perform risk assessments and implement mitigation strategies.
- Release finished products after reviewing all necessary quality documentation.
- Stay updated on current regulatory requirements and industry best practices.
- Contribute to the continuous improvement of quality processes.
- Bachelor's degree in Pharmacy, Chemistry, Biology, or a related science field. Advanced degree is a plus.
- Minimum of 3-5 years of experience in Quality Assurance or Quality Control within the pharmaceutical industry.
- In-depth knowledge of GMP, FDA, and other relevant pharmaceutical regulations.
- Experience with QMS, CAPA systems, and deviation management.
- Strong analytical, problem-solving, and documentation skills.
- Excellent attention to detail and accuracy.
- Proficiency in Microsoft Office Suite.
- Good communication and interpersonal skills.
- Ability to work effectively both independently and as part of a team.
- Experience with validation processes (process, equipment, cleaning) is desirable.
Pharmaceutical Quality Assurance Specialist
Posted today
Job Viewed
Job Description
Responsibilities:
- Develop, implement, and maintain the Quality Management System (QMS) in compliance with GMP, ICH, and other relevant regulatory guidelines.
- Conduct internal audits and inspections to ensure adherence to quality standards.
- Review and approve batch records, validation protocols, and manufacturing documentation.
- Investigate deviations, out-of-specification (OOS) results, and customer complaints, implementing corrective and preventive actions (CAPAs).
- Participate in external audits and inspections by regulatory authorities and clients.
- Collaborate with manufacturing, R&D, and regulatory affairs departments to resolve quality issues.
- Develop and deliver quality training programs to personnel.
- Monitor and analyze quality control data to identify trends and areas for improvement.
- Contribute to the qualification and validation of equipment and processes.
- Stay current with evolving regulatory requirements and industry best practices in the pharmaceutical sector.
- Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related scientific field.
- Minimum of 4 years of experience in Quality Assurance within the pharmaceutical industry.
- In-depth knowledge of Good Manufacturing Practices (GMP) and other relevant pharmaceutical regulations.
- Experience with QMS, CAPA systems, and deviation management.
- Proficiency in reviewing technical documents and performing quality audits.
- Strong analytical and problem-solving skills.
- Excellent written and verbal communication abilities.
- Ability to work independently and collaboratively in a remote team environment.
- Meticulous attention to detail and commitment to quality.
- Experience with sterile manufacturing or specific drug product categories is an advantage.
Pharmaceutical Quality Assurance Specialist
Posted today
Job Viewed
Job Description
Key Responsibilities:
- Review and approve batch production and control records.
- Investigate deviations, CAPAs, and out-of-specification results.
- Ensure compliance with GMP, GLP, and other regulatory guidelines.
- Develop, implement, and maintain quality management systems.
- Conduct internal audits and support external audits.
- Collaborate with manufacturing and R&D on quality-related issues.
- Analyze quality data and identify trends.
- Prepare quality documentation and reports.
- Participate in validation activities.
- Stay current with pharmaceutical regulations and quality standards.
- Proven experience as a Quality Assurance Specialist in the pharmaceutical industry.
- In-depth knowledge of GMP, GLP, and regulatory requirements (e.g., FDA, EMA).
- Experience with quality management systems and audit processes.
- Strong analytical and problem-solving skills.
- Excellent documentation and communication abilities.
- Ability to work independently and manage responsibilities in a remote environment.
- Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific field.
Pharmaceutical Quality Assurance Specialist
Posted today
Job Viewed
Job Description
Key responsibilities include conducting regular audits of manufacturing processes, reviewing batch records, and investigating deviations and non-conformances. You will be involved in validating manufacturing equipment and processes, as well as developing and executing quality control tests. The ability to analyze data, identify root causes of quality issues, and implement corrective and preventive actions (CAPAs) is essential. We are looking for a detail-oriented individual with strong analytical and problem-solving skills, coupled with excellent written and verbal communication abilities. Proficiency in documentation management and a thorough understanding of regulatory submissions and compliance are highly valued. Experience in the pharmaceutical or biotechnology industry is a prerequisite. You will play a key role in ensuring the safety and efficacy of pharmaceutical products and maintaining the company's commitment to quality excellence. Collaboration with R&D, production, and regulatory affairs teams will be integral to success in this role. Your expertise will contribute directly to patient safety and product integrity.
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Pharmaceutical Quality Assurance Specialist
Posted today
Job Viewed
Job Description
Key Responsibilities:
- Develop, implement, and maintain quality assurance programs and SOPs.
- Conduct internal audits and inspections of manufacturing processes and facilities.
- Review and approve batch records, validation protocols, and quality-related documents.
- Investigate deviations, CAPAs (Corrective and Preventive Actions), and customer complaints.
- Perform product release testing and ensure compliance with specifications.
- Collaborate with R&D, production, and regulatory affairs teams to ensure product quality.
- Train personnel on quality control procedures and GMP requirements.
- Stay updated on relevant industry regulations and quality standards.
- Participate in external audits by regulatory agencies.
- Contribute to continuous improvement initiatives for quality systems.
- Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific field.
- Minimum of 3 years of experience in pharmaceutical quality assurance or quality control.
- In-depth knowledge of GMP, ICH guidelines, and other relevant pharmaceutical regulations.
- Experience with quality management systems (QMS) and audit procedures.
- Strong analytical and problem-solving skills.
- Excellent documentation and technical writing skills.
- Proficiency in MS Office and quality management software.
- Ability to work effectively in a team-oriented environment.
Pharmaceutical Quality Assurance Specialist
Posted today
Job Viewed
Job Description
Pharmaceutical Quality Assurance Specialist
Posted today
Job Viewed
Job Description
Responsibilities:
- Implement and maintain the Quality Management System (QMS) according to pharmaceutical regulations.
- Conduct internal audits and ensure compliance with GMP and GLP.
- Review and approve batch records, validation reports, and other quality documents.
- Investigate deviations, OOS results, and customer complaints.
- Manage the change control process and ensure proper implementation.
- Participate in external audits and regulatory inspections.
- Collaborate with cross-functional teams to address quality issues.
- Contribute to the continuous improvement of quality processes and systems.
- Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science field.
- Minimum of 3-5 years of experience in Quality Assurance within the pharmaceutical industry.
- In-depth knowledge of GMP, GLP, and other relevant regulatory guidelines (e.g., FDA, EMA).
- Experience with quality control testing and data analysis.
- Strong understanding of pharmaceutical manufacturing processes.
- Excellent documentation, analytical, and problem-solving skills.
- Proficiency in quality management software is a plus.
- Ability to work effectively in a hybrid work environment.