4 Principal Pharmaceutical Quality Assurance Specialist jobs in whatjobs
Principal Pharmaceutical Quality Assurance Specialist
Posted 10 days ago
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Job Description
Our client, a leading global pharmaceutical company, is seeking a highly experienced Principal Pharmaceutical Quality Assurance Specialist to join their esteemed remote team. This role is pivotal in ensuring that all pharmaceutical products meet the highest standards of quality, safety, and efficacy, entirely managed through remote collaboration. You will be responsible for developing, implementing, and maintaining comprehensive quality management systems, including cGMP, GCP, and GLP compliance. Your duties will involve conducting internal audits, managing external audits, investigating deviations and CAPAs, and ensuring regulatory compliance with global health authorities. You will collaborate closely with R&D, manufacturing, and regulatory affairs departments to ensure product quality throughout the lifecycle. A significant part of your role will involve risk assessment, trend analysis of quality data, and continuous improvement initiatives to enhance product quality and process robustness. You will also be involved in the review and approval of documentation, including validation protocols, batch records, and change controls. This position requires a deep understanding of pharmaceutical manufacturing processes, analytical testing, and regulatory requirements. The ideal candidate will possess a Master's degree or PhD in Pharmacy, Chemistry, Biology, or a related life science field, with a minimum of 8 years of progressive experience in pharmaceutical quality assurance. Exceptional analytical, problem-solving, and critical thinking skills are essential. Strong knowledge of regulatory guidelines (FDA, EMA) and experience with electronic quality management systems (eQMS) are highly desirable. You must be adept at working independently, managing complex quality projects remotely, and fostering a strong quality culture across distributed teams. This is a remarkable opportunity to contribute significantly to patient safety and drug quality within a world-class pharmaceutical organization, operating entirely in a remote capacity.
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Principal Pharmaceutical Quality Assurance Specialist
Posted 9 days ago
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Job Description
Our client, a distinguished pharmaceutical company dedicated to developing life-changing medications, is seeking a highly experienced Principal Pharmaceutical Quality Assurance Specialist to join their remote-first team. This role is crucial for ensuring that all our products meet the highest standards of quality, safety, and efficacy, in compliance with global regulatory requirements. You will lead initiatives to enhance our Quality Management System (QMS), conduct internal audits, and provide expert guidance on QA best practices across all stages of drug development and manufacturing.
Key Responsibilities:
Key Responsibilities:
- Lead and manage quality assurance activities for pharmaceutical products, from development through commercialization.
- Develop, implement, and maintain robust Quality Management Systems (QMS) compliant with GMP, ICH, and other relevant global regulations.
- Conduct comprehensive internal audits of manufacturing processes, documentation, and data integrity to identify deviations and areas for improvement.
- Review and approve critical quality documents, including batch records, validation protocols, and deviation reports.
- Provide expert guidance and training to cross-functional teams on QA principles, GMP compliance, and regulatory requirements.
- Lead investigations into quality deviations, root cause analyses, and the implementation of effective corrective and preventive actions (CAPAs).
- Liaise with regulatory agencies during inspections and manage responses to regulatory queries.
- Stay abreast of evolving regulatory landscapes and implement necessary changes to ensure ongoing compliance.
- Assess and qualify suppliers and contract manufacturers to ensure adherence to quality standards.
- Drive continuous improvement initiatives within the QA function and across the organization.
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Principal Pharmaceutical Quality Assurance Specialist
Posted 5 days ago
Job Viewed
Job Description
Our client, a reputable pharmaceutical manufacturer, is seeking a highly accomplished Principal Pharmaceutical Quality Assurance Specialist to enhance their quality management systems. This is a crucial, fully remote position, allowing an expert to drive quality initiatives across the organization without geographical constraints. The successful candidate will be responsible for developing, implementing, and maintaining robust quality assurance programs, ensuring compliance with all relevant regulatory standards, including GMP, GDP, and ICH guidelines. You will lead audits, manage deviations and CAPAs, and oversee change control processes to uphold the highest quality standards.
This role demands a meticulous attention to detail, a comprehensive understanding of pharmaceutical manufacturing processes, and a strong command of quality control principles. You will be instrumental in conducting internal and external audits, supplier quality management, and risk assessments. The Principal Pharmaceutical Quality Assurance Specialist will also be responsible for training personnel on quality systems and procedures, fostering a culture of quality throughout the organization. You will analyze quality data, identify trends, and propose continuous improvement initiatives to enhance product safety and efficacy. The ability to interpret complex regulatory requirements, implement effective quality solutions, and lead cross-functional teams in a remote setting is essential. This is an excellent opportunity for a seasoned QA professional to make a significant impact on product quality and regulatory compliance.
Responsibilities:
This role demands a meticulous attention to detail, a comprehensive understanding of pharmaceutical manufacturing processes, and a strong command of quality control principles. You will be instrumental in conducting internal and external audits, supplier quality management, and risk assessments. The Principal Pharmaceutical Quality Assurance Specialist will also be responsible for training personnel on quality systems and procedures, fostering a culture of quality throughout the organization. You will analyze quality data, identify trends, and propose continuous improvement initiatives to enhance product safety and efficacy. The ability to interpret complex regulatory requirements, implement effective quality solutions, and lead cross-functional teams in a remote setting is essential. This is an excellent opportunity for a seasoned QA professional to make a significant impact on product quality and regulatory compliance.
Responsibilities:
- Develop and maintain pharmaceutical quality assurance systems and SOPs.
- Ensure compliance with GMP, GDP, and other relevant pharmaceutical regulations.
- Lead internal and external audits, including supplier audits.
- Manage deviation investigations, CAPA implementation, and change control processes.
- Analyze quality data, identify trends, and implement corrective and preventive actions.
- Oversee risk management activities related to product quality.
- Train staff on quality assurance procedures and regulatory requirements.
- Collaborate with manufacturing, R&D, and regulatory affairs teams.
- Champion a strong quality culture throughout the organization.
- Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science discipline.
- Advanced degree or relevant certifications (e.g., ASQ CQA) are a plus.
- Minimum of 10 years of experience in pharmaceutical quality assurance.
- In-depth knowledge of GMP, GDP, ICH guidelines, and regulatory submission processes.
- Proven experience in conducting audits, managing deviations, and implementing CAPAs.
- Strong analytical and problem-solving skills.
- Excellent leadership, communication, and interpersonal skills.
- Ability to interpret complex regulatory requirements and drive compliance.
- Experience leading quality initiatives in a remote environment.
This advertiser has chosen not to accept applicants from your region.
2
Principal Pharmaceutical Quality Assurance Specialist
Posted 5 days ago
Job Viewed
Job Description
Our client is seeking a highly experienced and motivated Principal Pharmaceutical Quality Assurance Specialist to lead and enhance their quality systems. This is a fully remote, critical role, offering the flexibility to work from anywhere while maintaining the highest standards of pharmaceutical product quality and compliance. You will be responsible for developing, implementing, and maintaining robust quality assurance programs, ensuring adherence to global regulatory requirements (e.g., FDA, EMA, WHO GMP). Your expertise will be vital in overseeing all aspects of quality control, risk management, and continuous improvement initiatives within the pharmaceutical manufacturing lifecycle. This role requires a deep understanding of pharmaceutical regulations, quality management systems, and a proactive approach to ensuring product safety and efficacy.
Key Responsibilities:
Qualifications:
Key Responsibilities:
- Lead the development, implementation, and continuous improvement of the Quality Management System (QMS) in accordance with cGMP, ICH, and other relevant regulatory guidelines.
- Oversee and manage quality assurance activities, including batch record review, deviation investigation, CAPA management, and change control.
- Conduct internal and external audits (supplier audits) to ensure compliance with regulatory standards and company policies.
- Develop and implement validation strategies for manufacturing processes, equipment, and analytical methods.
- Prepare and review regulatory submission documents related to quality aspects.
- Lead and participate in regulatory inspections by health authorities, ensuring successful outcomes.
- Develop and deliver training programs on quality assurance principles and regulatory compliance for relevant personnel.
- Identify quality risks and implement effective risk mitigation strategies throughout the product lifecycle.
- Analyze quality data to identify trends, root causes of deviations, and areas for improvement.
- Collaborate with R&D, manufacturing, and regulatory affairs departments to ensure seamless integration of quality considerations into all project phases.
Qualifications:
- Master's degree or PhD in Pharmacy, Chemistry, Biology, or a related life science field.
- Minimum of 10 years of progressive experience in pharmaceutical quality assurance and quality control, with at least 5 years in a leadership or principal specialist role.
- In-depth knowledge of cGMP, ICH guidelines, and regulatory requirements in major markets (US, EU, etc.).
- Proven experience in developing and managing comprehensive QMS, including OOS investigations, CAPA, and change control.
- Strong experience with audits (internal, external, regulatory) and regulatory submissions.
- Excellent analytical, problem-solving, and decision-making skills.
- Exceptional written and verbal communication skills, with the ability to effectively present complex information to diverse audiences.
- Demonstrated ability to lead teams and drive quality initiatives in a remote setting.
- Proficiency in using quality management software and data analysis tools.
- Strong understanding of pharmaceutical manufacturing processes and technologies.
This advertiser has chosen not to accept applicants from your region.
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