2 Pharmaceutical Quality Assurance Specialist jobs in WhatJobs Direct
Pharmaceutical Quality Assurance Specialist
Posted 5 days ago
Job Viewed
Job Description
Our client is seeking a meticulous and experienced Pharmaceutical Quality Assurance Specialist to join their team, based in **Machakos, Machakos, KE**. This role is pivotal in ensuring that all pharmaceutical products meet stringent quality standards and comply with regulatory requirements. The ideal candidate will have a strong understanding of GMP (Good Manufacturing Practices) and QA principles within the pharmaceutical industry.
Key responsibilities include developing, implementing, and maintaining the Quality Management System (QMS). You will be responsible for reviewing and approving batch records, validation protocols, and other critical documentation. Conducting internal audits to assess compliance with established procedures and regulatory guidelines will be a significant part of your role. Identifying deviations, investigating root causes, and implementing corrective and preventive actions (CAPAs) are essential duties.
The QA Specialist will also participate in external audits by regulatory authorities and customers, and may be involved in supplier qualification and audits. You will contribute to the continuous improvement of quality processes and systems. Ensuring product quality throughout the entire lifecycle, from raw material sourcing to finished product release, is paramount. Training personnel on quality standards and procedures may also be required.
A Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science field is required. A minimum of 3-5 years of experience in Quality Assurance within the pharmaceutical industry is essential. A thorough understanding of ICH guidelines, FDA regulations, and other relevant international pharmaceutical standards is mandatory. Excellent analytical, problem-solving, and documentation skills are crucial. Strong communication and interpersonal skills are necessary to collaborate effectively with various departments. This is a hybrid role, requiring a blend of on-site presence in **Machakos, Machakos, KE** and the flexibility of remote work.
Key responsibilities include developing, implementing, and maintaining the Quality Management System (QMS). You will be responsible for reviewing and approving batch records, validation protocols, and other critical documentation. Conducting internal audits to assess compliance with established procedures and regulatory guidelines will be a significant part of your role. Identifying deviations, investigating root causes, and implementing corrective and preventive actions (CAPAs) are essential duties.
The QA Specialist will also participate in external audits by regulatory authorities and customers, and may be involved in supplier qualification and audits. You will contribute to the continuous improvement of quality processes and systems. Ensuring product quality throughout the entire lifecycle, from raw material sourcing to finished product release, is paramount. Training personnel on quality standards and procedures may also be required.
A Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science field is required. A minimum of 3-5 years of experience in Quality Assurance within the pharmaceutical industry is essential. A thorough understanding of ICH guidelines, FDA regulations, and other relevant international pharmaceutical standards is mandatory. Excellent analytical, problem-solving, and documentation skills are crucial. Strong communication and interpersonal skills are necessary to collaborate effectively with various departments. This is a hybrid role, requiring a blend of on-site presence in **Machakos, Machakos, KE** and the flexibility of remote work.
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Pharmaceutical Quality Assurance Specialist
Posted 5 days ago
Job Viewed
Job Description
Our client is seeking a meticulous and experienced Pharmaceutical Quality Assurance Specialist to join their fully remote Quality department. This role is integral to ensuring that all pharmaceutical products meet stringent quality standards and regulatory compliance requirements. The Quality Assurance Specialist will be responsible for developing, implementing, and maintaining quality management systems (QMS), including SOPs, batch record review, and deviation investigations. You will play a key role in conducting internal audits, supplier audits, and ensuring compliance with Good Manufacturing Practices (GMP) and other relevant regulations. The successful candidate will possess a strong understanding of pharmaceutical manufacturing processes, quality control methodologies, and regulatory affairs. This is a remote-first position, requiring exceptional organizational skills, attention to detail, and the ability to manage complex documentation and processes independently. Strong analytical and problem-solving skills are essential for investigating quality issues and implementing corrective and preventive actions (CAPA). Collaboration with cross-functional teams, including R&D, manufacturing, and regulatory affairs, will be crucial. This is an excellent opportunity for a dedicated QA professional to contribute to the safety and efficacy of pharmaceutical products within a flexible, remote work environment. The role demands a proactive approach to identifying potential quality risks and implementing robust solutions to mitigate them, ensuring adherence to the highest industry standards. The position is focused on supporting operations near Nakuru, Nakuru, KE , but is operated entirely remotely.
Responsibilities:
Responsibilities:
- Develop and maintain the Quality Management System (QMS), including SOPs and work instructions.
- Conduct batch record reviews and ensure compliance with regulatory requirements.
- Investigate deviations, customer complaints, and Out-of-Specification (OOS) results.
- Implement and manage Corrective and Preventive Actions (CAPA).
- Perform internal audits and support external audits by regulatory agencies.
- Evaluate and qualify suppliers to ensure quality standards are met.
- Monitor and analyze quality metrics and trends to identify areas for improvement.
- Ensure compliance with GMP, GDP, and other relevant pharmaceutical regulations.
- Provide training to personnel on quality standards and procedures.
- Stay updated on regulatory changes and industry best practices.
- Bachelor'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.
- In-depth knowledge of GMP, ICH guidelines, and pharmaceutical regulatory requirements.
- Proven experience in QMS implementation, SOP development, and batch record review.
- Strong understanding of pharmaceutical manufacturing processes.
- Excellent analytical, problem-solving, and critical thinking skills.
- Proficiency in quality investigation techniques and CAPA management.
- Strong written and verbal communication skills for documentation and interdepartmental collaboration.
- Ability to work independently and manage multiple projects in a remote setting.
- Attention to detail and a commitment to maintaining high-quality standards.
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