4 Senior Pharmaceutical Quality Assurance Analyst jobs in whatjobs
Senior Pharmaceutical Quality Assurance Analyst
Posted 12 days ago
Job Viewed
Job Description
Our client is looking for a highly experienced Senior Pharmaceutical Quality Assurance Analyst to join their team. This role is integral to ensuring that all pharmaceutical products meet stringent quality standards and regulatory requirements. The analyst will be responsible for developing, implementing, and maintaining quality assurance systems and procedures throughout the product lifecycle, from raw material testing to finished product release. Key duties include conducting in-depth analysis of manufacturing processes, reviewing batch records, investigating deviations and out-of-specification (OOS) results, and implementing corrective and preventive actions (CAPA).
You will play a crucial role in preparing for and participating in internal and external audits, including regulatory inspections. The ideal candidate will possess a deep understanding of Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and relevant pharmaceutical regulations (e.g., FDA, EMA). Strong analytical skills, meticulous attention to detail, and excellent problem-solving abilities are essential. You will be responsible for trend analysis of quality data, identifying potential risks, and recommending improvements to quality systems. Collaboration with cross-functional teams, including R&D, manufacturing, and regulatory affairs, will be a significant aspect of the role. Excellent written and verbal communication skills are required for documenting findings and communicating with stakeholders. This position offers a hybrid work arrangement, combining remote flexibility with occasional on-site presence for critical activities. This is a challenging and rewarding opportunity to contribute to the safety and efficacy of pharmaceutical products within a leading organization.
Location Highlight: This role offers a hybrid work arrangement, with a primary focus on operations related to Bungoma, Bungoma, KE .
You will play a crucial role in preparing for and participating in internal and external audits, including regulatory inspections. The ideal candidate will possess a deep understanding of Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and relevant pharmaceutical regulations (e.g., FDA, EMA). Strong analytical skills, meticulous attention to detail, and excellent problem-solving abilities are essential. You will be responsible for trend analysis of quality data, identifying potential risks, and recommending improvements to quality systems. Collaboration with cross-functional teams, including R&D, manufacturing, and regulatory affairs, will be a significant aspect of the role. Excellent written and verbal communication skills are required for documenting findings and communicating with stakeholders. This position offers a hybrid work arrangement, combining remote flexibility with occasional on-site presence for critical activities. This is a challenging and rewarding opportunity to contribute to the safety and efficacy of pharmaceutical products within a leading organization.
Location Highlight: This role offers a hybrid work arrangement, with a primary focus on operations related to Bungoma, Bungoma, KE .
This advertiser has chosen not to accept applicants from your region.
0
Senior Pharmaceutical Quality Assurance Analyst
Posted 10 days ago
Job Viewed
Job Description
Our client, a leading innovator in the pharmaceutical industry, is seeking a highly experienced Senior Pharmaceutical Quality Assurance Analyst to join their globally distributed team. This is a crucial, fully remote role focused on ensuring the highest standards of quality and compliance across all pharmaceutical products and processes. The ideal candidate will possess a deep understanding of regulatory requirements, Good Manufacturing Practices (GMP), and quality management systems within the pharmaceutical sector. You will be instrumental in developing, implementing, and maintaining robust quality assurance frameworks, conducting thorough risk assessments, and driving continuous improvement in quality metrics. This position requires meticulous attention to detail, excellent analytical skills, and the ability to work independently while collaborating effectively with cross-functional teams, including R&D, manufacturing, and regulatory affairs. The ability to interpret complex data, identify deviations, and propose effective CAPA (Corrective and Preventive Actions) is paramount.
Responsibilities:
Responsibilities:
- Develop, implement, and maintain quality assurance policies and procedures in accordance with regulatory guidelines (e.g., FDA, EMA, WHO).
- Conduct internal audits and assessments of manufacturing sites, processes, and systems to ensure compliance.
- Review and approve validation protocols and reports for equipment, processes, and analytical methods.
- Investigate deviations, out-of-specification (OOS) results, and customer complaints, determining root causes and implementing corrective and preventive actions.
- Analyze quality data and trends to identify potential risks and areas for improvement.
- Collaborate with R&D, manufacturing, and other departments to ensure quality is built into new product development and process changes.
- Prepare and review documentation for regulatory submissions.
- Stay abreast of current regulatory requirements and industry best practices.
- Provide training and guidance to staff on quality assurance principles and procedures.
- Manage external quality audits and inspections by regulatory authorities.
- Contribute to the continuous improvement of the Quality Management System.
- Master's degree or Ph.D. in Pharmacy, Chemistry, Biology, or a related life science field.
- Minimum of 8-10 years of progressive experience in pharmaceutical quality assurance and quality control.
- Extensive knowledge of GMP, ICH guidelines, and relevant global pharmaceutical regulations.
- Demonstrated experience in conducting audits, investigations, and risk assessments.
- Strong analytical and problem-solving skills with a keen attention to detail.
- Excellent written and verbal communication skills, with the ability to present complex information clearly.
- Proven ability to work autonomously and manage multiple projects in a remote environment.
- Experience with data integrity principles and electronic quality management systems (eQMS).
- Strong project management and organizational skills.
This advertiser has chosen not to accept applicants from your region.
1
Senior Pharmaceutical Quality Assurance Analyst
Posted 6 days ago
Job Viewed
Job Description
Our client, a leader in the pharmaceutical industry, is seeking a highly experienced Senior Pharmaceutical Quality Assurance Analyst to join their team in Kakamega, Kakamega, KE . This critical role involves ensuring that all pharmaceutical products meet stringent quality standards and regulatory requirements. You will be responsible for developing, implementing, and maintaining quality assurance systems and procedures throughout the manufacturing process, from raw material inspection to finished product release. Key duties include conducting thorough investigations of deviations and out-of-specification results, implementing corrective and preventive actions (CAPAs), and participating in internal and external audits. The ideal candidate will possess a deep understanding of Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and relevant regulatory guidelines (e.g., FDA, EMA). You will play a vital role in process validation, equipment qualification, and stability testing. Collaborating closely with R&D, production, and regulatory affairs departments will be essential to ensure seamless quality control. This position requires exceptional analytical and problem-solving skills, meticulous attention to detail, and strong documentation abilities. A Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific field is required, along with a minimum of 5 years of experience in pharmaceutical quality assurance. Strong leadership potential and the ability to mentor junior team members are also highly valued. This role demands a proactive approach to quality management and a commitment to upholding the highest standards of product safety and efficacy. You will be instrumental in driving continuous improvement within the quality assurance framework and ensuring compliance with all applicable regulations. The successful candidate will demonstrate excellent communication skills and the ability to work effectively within a team environment. This is a challenging yet rewarding opportunity to contribute to the development and production of life-saving medicines.
This advertiser has chosen not to accept applicants from your region.
2
Senior Pharmaceutical Quality Assurance Analyst
Posted 3 days ago
Job Viewed
Job Description
Our client is looking for a highly experienced Senior Pharmaceutical Quality Assurance Analyst to join their fully remote team. This critical role involves ensuring the highest standards of quality and compliance across all pharmaceutical products and processes. You will be responsible for developing, implementing, and maintaining robust quality systems that meet stringent regulatory requirements. The ideal candidate will have a proven track record in pharmaceutical quality assurance and a meticulous attention to detail. This is an exciting opportunity to contribute to the development and delivery of safe and effective medicines while working from anywhere.
Responsibilities:
Responsibilities:
- Develop, review, and approve quality control procedures and protocols.
- Conduct internal audits to ensure compliance with GMP, GDP, and other relevant regulations.
- Investigate deviations, out-of-specification results, and customer complaints, implementing corrective and preventive actions (CAPA).
- Manage and maintain the company's Quality Management System (QMS).
- Review and approve batch records, validation protocols, and reports.
- Collaborate with R&D, manufacturing, and regulatory affairs departments to ensure product quality.
- Stay updated on pharmaceutical industry trends, regulations, and best practices.
- Train and mentor junior QA staff.
- Participate in regulatory inspections and customer audits.
- Contribute to the continuous improvement of quality processes and systems.
- Master's degree in Pharmacy, Chemistry, Biology, or a related life science field.
- Minimum of 7 years of experience in pharmaceutical quality assurance or quality control.
- In-depth knowledge of GMP, ICH guidelines, and regulatory requirements (e.g., FDA, EMA).
- Experience with QMS software and electronic batch record systems.
- Strong analytical, problem-solving, and critical thinking skills.
- Excellent written and verbal communication skills.
- Ability to manage multiple projects simultaneously and meet deadlines.
- Experience in auditing and CAPA management.
- Detail-oriented with a strong commitment to quality and compliance.
- Proven ability to work effectively in a remote, collaborative environment.
This advertiser has chosen not to accept applicants from your region.
Be The First To Know
About the latest Senior pharmaceutical quality assurance analyst Jobs in Kenya !
3