96 Remote Pharmaceutical Quality Assurance Specialist jobs in whatjobs
Remote Pharmaceutical Quality Assurance Specialist
Posted 20 days ago
Job Viewed
Job Description
The ideal candidate will possess a thorough understanding of Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and other relevant pharmaceutical quality standards. You will be responsible for reviewing and approving batch records, deviations, change controls, and other quality-related documentation. Your role will involve participating in internal audits, supporting external regulatory inspections, and contributing to the continuous improvement of quality processes. You will work closely with manufacturing, R&D, and regulatory affairs teams to ensure all activities comply with established procedures and regulatory guidelines. Strong analytical skills, meticulous attention to detail, and excellent written and verbal communication abilities are essential for success in this role.
Key responsibilities include:
- Reviewing and approving batch manufacturing records (BMRs) and analytical testing results.
- Investigating deviations, out-of-specification (OOS) results, and customer complaints.
- Managing change control processes and ensuring proper implementation.
- Participating in and supporting internal and external audits (e.g., FDA, EMA).
- Developing and updating Standard Operating Procedures (SOPs) and quality guidelines.
- Ensuring compliance with current Good Manufacturing Practices (cGMP) and other regulatory requirements.
- Conducting risk assessments and implementing corrective and preventive actions (CAPAs).
- Collaborating with cross-functional teams to resolve quality issues.
- Monitoring and reporting on key quality metrics and performance indicators.
- Contributing to the overall quality management system (QMS).
This is a fully remote position, offering the flexibility to work from your preferred location. We require candidates with a Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science field, and a minimum of 3-5 years of experience in pharmaceutical quality assurance or quality control. In-depth knowledge of pharmaceutical regulations and quality systems is essential. Strong analytical, problem-solving, and documentation skills are a must. Join our dedicated team and uphold the highest standards of quality in the pharmaceutical industry.
Remote Pharmaceutical Quality Assurance Specialist
Posted 20 days ago
Job Viewed
Job Description
Key Responsibilities:
- Review and approve batch records, validation documents, and change controls.
- Ensure compliance with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and other relevant regulations.
- Participate in internal and external audits and inspections.
- Develop, implement, and maintain Quality Management Systems (QMS).
- Investigate deviations, out-of-specification results, and customer complaints.
- Conduct risk assessments and implement CAPA (Corrective and Preventive Actions).
- Prepare and review Standard Operating Procedures (SOPs) and work instructions.
- Train personnel on quality assurance principles and procedures.
- Monitor quality metrics and prepare quality reports for management.
- Collaborate with cross-functional teams, including R&D, manufacturing, and regulatory affairs.
- Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science field.
- Minimum of 4 years of experience in Quality Assurance within the pharmaceutical industry.
- In-depth knowledge of GMP, ICH guidelines, and regulatory requirements.
- Experience with electronic QMS and document control systems.
- Strong understanding of pharmaceutical manufacturing processes.
- Excellent analytical, problem-solving, and critical thinking skills.
- Exceptional attention to detail and commitment to accuracy.
- Effective written and verbal communication skills for remote collaboration.
- Ability to work independently and manage tasks efficiently in a remote environment.
- Experience with pharmacovigilance is a plus.
Remote Pharmaceutical Quality Assurance Specialist
Posted 20 days ago
Job Viewed
Job Description
Remote Pharmaceutical Quality Assurance Specialist
Posted 20 days ago
Job Viewed
Job Description
Responsibilities:
- Develop, implement, and manage quality assurance systems and procedures in accordance with cGMP, ICH, and other relevant regulatory guidelines.
- Conduct internal and external audits of manufacturing facilities, suppliers, and contract research organizations (CROs).
- Review and approve batch records, validation protocols, and reports for pharmaceutical products.
- Manage deviations, CAPAs (Corrective and Preventive Actions), and change control processes.
- Prepare and submit regulatory documentation for product registration and lifecycle management.
- Conduct risk assessments and implement risk mitigation strategies to ensure product quality and patient safety.
- Stay abreast of evolving regulatory requirements and industry best practices in pharmaceutical quality assurance.
- Train and mentor internal teams and external partners on quality standards and procedures.
- Investigate quality complaints and product deviations, implementing appropriate corrective actions.
- Contribute to the continuous improvement of quality processes and systems.
- Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, Pharmaceutical Sciences, or a related field.
- Minimum of 6 years of progressive experience in pharmaceutical quality assurance and quality control.
- In-depth knowledge of cGMP, GLP, GCP, and relevant international regulatory guidelines (e.g., FDA, EMA, WHO).
- Proven experience in conducting audits, managing deviations, and implementing CAPA systems.
- Strong understanding of pharmaceutical manufacturing processes and analytical methods.
- Excellent analytical, problem-solving, and critical thinking skills.
- Exceptional attention to detail and commitment to accuracy.
- Outstanding written and verbal communication skills, with the ability to prepare clear and concise documentation.
- Demonstrated ability to work independently, manage multiple projects, and meet deadlines in a remote setting.
- Proficiency in quality management software and common office applications.
Remote Pharmaceutical Quality Assurance Specialist
Posted 20 days ago
Job Viewed
Job Description
Remote Pharmaceutical Quality Assurance Specialist
Posted 20 days ago
Job Viewed
Job Description
Responsibilities:
- Develop, implement, and maintain quality management systems and procedures.
- Review and approve batch records, validation protocols, and other quality-related documentation.
- Conduct internal audits and participate in external audits of suppliers and partners.
- Investigate deviations, out-of-specifications (OOS) results, and customer complaints.
- Develop and implement corrective and preventive actions (CAPA) to address quality issues.
- Ensure compliance with relevant regulatory requirements (e.g., FDA, EMA, local health authorities).
- Train personnel on quality assurance policies and procedures.
- Monitor and analyze quality metrics and trends, reporting findings to management.
- Participate in process validation and qualification activities.
- Manage the change control process effectively.
- Stay updated on regulatory changes and industry best practices in pharmaceutical quality assurance.
- Contribute to the continuous improvement of quality systems.
- Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science field.
- Minimum of 3-5 years of experience in pharmaceutical quality assurance or quality control.
- In-depth knowledge of GMP, GLP, and other relevant quality standards.
- Familiarity with regulatory submission processes and requirements.
- Strong understanding of pharmaceutical manufacturing processes.
- Excellent analytical, problem-solving, and investigative skills.
- Exceptional attention to detail and accuracy.
- Strong written and verbal communication skills, adapted for remote collaboration.
- Ability to work independently, prioritize tasks, and manage time effectively in a remote environment.
- Proficiency in quality management software and MS Office Suite.
Remote Pharmaceutical Quality Assurance Specialist
Posted 20 days ago
Job Viewed
Job Description
Key responsibilities include reviewing and approving batch records, investigating deviations and out-of-specification results, and implementing corrective and preventive actions (CAPA). You will also participate in internal and external audits, conduct risk assessments, and contribute to the continuous improvement of quality processes. This role requires a strong understanding of Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and relevant regulatory guidelines (e.g., FDA, EMA). You will collaborate with cross-functional teams, including R&D, manufacturing, and regulatory affairs, to ensure product quality throughout its lifecycle. The ideal candidate is highly detail-oriented, possesses excellent analytical and problem-solving skills, and can communicate complex quality-related issues effectively in a remote environment. This is a critical role for ensuring the safety and efficacy of pharmaceutical products.
Qualifications:
- Bachelor's degree in Pharmacy, Chemistry, Biology, or a related science field.
- Minimum of 4 years of experience in pharmaceutical quality assurance or quality control.
- In-depth knowledge of GMP, GLP, and other relevant regulatory guidelines.
- Experience with deviation investigations, CAPA, and change control systems.
- Strong analytical and problem-solving skills.
- Excellent written and verbal communication skills.
- Proficiency in quality management software and standard office applications.
- Ability to work independently and manage tasks effectively in a remote setting.
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Remote Pharmaceutical Quality Assurance Specialist
Posted 20 days ago
Job Viewed
Job Description
Key Responsibilities:
- Develop, implement, and maintain quality assurance policies and procedures in accordance with GxP regulations (GMP, GCP, GLP).
- Conduct internal audits and inspections to assess compliance with quality standards and regulatory requirements.
- Review and approve manufacturing batch records, validation protocols, and other critical documentation.
- Investigate deviations, out-of-specification (OOS) results, and customer complaints, implementing corrective and preventive actions (CAPAs).
- Participate in the qualification and validation of equipment, processes, and analytical methods.
- Monitor and manage quality metrics and key performance indicators (KPIs).
- Prepare for and support regulatory agency inspections (e.g., FDA, EMA).
- Collaborate with various departments (e.g., manufacturing, R&D, regulatory affairs) to ensure quality throughout the product lifecycle.
- Stay current with evolving regulatory guidelines and industry trends.
- Train personnel on quality assurance principles and procedures.
- Manage vendor quality agreements and audits.
- Contribute to the continuous improvement of the Quality Management System (QMS).
- Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science field.
- Minimum of 3 years of experience in pharmaceutical Quality Assurance or Quality Control.
- Thorough understanding of Good Manufacturing Practices (GMP) and other relevant GxP regulations.
- Experience with document control, CAPA systems, change control, and deviation investigations.
- Familiarity with validation principles and execution.
- Strong analytical and problem-solving skills.
- Excellent attention to detail and organizational abilities.
- Effective written and verbal communication skills.
- Ability to work independently, manage priorities, and meet deadlines in a remote setting.
- Proficiency in MS Office Suite and experience with QMS software is advantageous.
- Ability to collaborate effectively with diverse teams.
Remote Pharmaceutical Quality Assurance Specialist
Posted 20 days ago
Job Viewed
Job Description
Responsibilities:
- Develop, implement, and maintain Quality Management Systems (QMS) in line with GMP and regulatory standards.
- Review and approve batch manufacturing records, analytical test results, and other quality-related documentation.
- Investigate deviations, out-of-specification (OOS) results, and customer complaints.
- Develop and implement Corrective and Preventive Actions (CAPA).
- Conduct internal audits and support external regulatory inspections.
- Participate in risk assessment activities and contribute to Quality Risk Management (QRM).
- Manage change control processes for procedures, equipment, and materials.
- Ensure compliance with all applicable pharmaceutical regulations and guidelines.
- Collaborate with cross-functional teams (R&D, manufacturing, regulatory affairs) to resolve quality issues.
- Train personnel on quality systems and GMP requirements.
- Stay current with evolving regulatory landscapes and industry best practices.
- Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science field.
- Minimum of 5 years of experience in pharmaceutical quality assurance or quality control.
- Thorough understanding of GMP, ICH guidelines, and other relevant regulatory requirements.
- Experience with batch record review, deviation investigations, and CAPA management.
- Strong analytical and problem-solving skills with excellent attention to detail.
- Proficiency in quality management software and standard office applications.
- Excellent written and verbal communication skills.
- Ability to work independently, manage priorities, and meet deadlines in a remote setting.
- Experience with virtual audits and remote quality oversight is a plus.
Remote Pharmaceutical Quality Assurance Specialist
Posted 20 days ago
Job Viewed
Job Description
Responsibilities will include developing, implementing, and maintaining quality management systems (QMS) in compliance with cGMP and other relevant regulatory guidelines. You will conduct internal audits and inspections, identify non-conformities, and oversee the implementation of corrective and preventive actions (CAPA). Reviewing and approving batch records, validation protocols, and other critical documentation will be a core part of your daily tasks. You will also be responsible for investigating deviations, customer complaints, and out-of-specification (OOS) results, ensuring thorough root cause analysis and resolution. The ideal candidate will have a strong understanding of pharmaceutical manufacturing processes, quality control principles, and regulatory affairs. Excellent written and verbal communication skills are a must, as you will be interacting with various departments and potentially external regulatory bodies. You should be adept at risk assessment and management, with a keen eye for detail and a commitment to continuous improvement. This role requires a proactive approach to quality assurance, a commitment to ethical practices, and the ability to work independently while managing multiple priorities. Staying updated on evolving pharmaceutical regulations and quality standards will be critical to your success. The opportunity to significantly contribute to the quality and safety of life-saving medications.
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