2 Senior Pharmaceutical Quality Assurance Specialist Remote Compliance Officer jobs in whatjobs
Senior Pharmaceutical Quality Assurance Specialist - Remote Compliance Officer
Posted 22 days ago
Job Viewed
Job Description
Our client is seeking a highly experienced and meticulous Senior Pharmaceutical Quality Assurance Specialist to join their fully remote global team. This role is crucial for ensuring the integrity, safety, and efficacy of pharmaceutical products by upholding stringent quality standards and regulatory compliance. As a remote specialist, you will be responsible for developing, implementing, and maintaining robust quality management systems, conducting comprehensive audits, and driving continuous improvement initiatives across all stages of drug development and manufacturing. Your expertise will be vital in navigating the complex regulatory landscape and ensuring adherence to Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and other relevant guidelines.
Key responsibilities include:
Key responsibilities include:
- Developing, implementing, and overseeing pharmaceutical quality assurance programs and policies.
- Conducting internal and external audits of manufacturing facilities, laboratories, and clinical trial sites to ensure compliance with regulatory standards (e.g., FDA, EMA, WHO).
- Reviewing and approving batch records, validation protocols, and other critical quality documentation.
- Investigating deviations, out-of-specification (OOS) results, and customer complaints, implementing corrective and preventive actions (CAPAs).
- Ensuring that all pharmaceutical products meet predefined quality specifications and regulatory requirements before release.
- Collaborating closely with R&D, manufacturing, regulatory affairs, and clinical teams to ensure quality is integrated throughout the product lifecycle.
- Developing and delivering quality assurance training programs for relevant personnel.
- Managing and maintaining the company's Quality Management System (QMS), including document control, change control, and risk management processes.
- Staying updated on current pharmaceutical regulations, industry trends, and best practices in quality assurance.
- Preparing for and hosting regulatory inspections and customer audits.
- A Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science field. A Ph.D. is a plus.
- A minimum of 7-10 years of progressive experience in pharmaceutical quality assurance and/or quality control.
- In-depth knowledge of GMP, GCP, ICH guidelines, and other relevant global regulatory requirements.
- Proven experience in conducting successful regulatory audits and hosting inspections.
- Strong analytical skills with the ability to interpret complex data and resolve quality issues effectively.
- Excellent project management and organizational skills, with the ability to manage multiple tasks and projects concurrently in a remote setting.
- Outstanding written and verbal communication skills, with the ability to articulate complex quality and regulatory issues clearly.
- Proficiency in quality management software and tools.
- A proactive approach to problem-solving and a commitment to maintaining the highest quality standards.
This advertiser has chosen not to accept applicants from your region.
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Senior Pharmaceutical Quality Assurance Specialist - Remote Compliance Officer
Posted 12 days ago
Job Viewed
Job Description
Our client is seeking a highly skilled and detail-oriented Senior Pharmaceutical Quality Assurance Specialist to ensure the highest standards of quality and compliance within their operations. This is a fully remote position, offering the flexibility to work from anywhere. The ideal candidate will have a robust understanding of pharmaceutical manufacturing processes, regulatory requirements (e.g., GMP, FDA, WHO), and quality management systems. You will be responsible for developing, implementing, and maintaining quality assurance protocols, conducting internal audits, reviewing batch records, and ensuring that all products meet stringent quality and safety standards. This role demands excellent analytical skills, meticulous attention to detail, and the ability to identify and resolve complex quality issues. You will collaborate closely with R&D, manufacturing, and regulatory affairs teams to ensure seamless integration of quality processes throughout the product lifecycle. The successful candidate will also play a key role in preparing for external audits and inspections, ensuring that documentation is accurate and complete. This is an excellent opportunity to contribute to the development and delivery of safe and effective pharmaceutical products, working within a remote-first environment that prioritizes collaboration and professional development. The position supports pharmaceutical quality assurance activities that might be associated with **Ongata Rongai, Kajiado, KE**, though physical presence is not required. You will be instrumental in upholding the company's commitment to quality and regulatory compliance, ensuring patient safety and product integrity.
Key Responsibilities:
Key Responsibilities:
- Develop, implement, and maintain Quality Assurance (QA) policies and procedures.
- Ensure compliance with Good Manufacturing Practices (GMP) and other relevant regulatory guidelines.
- Conduct internal audits of manufacturing processes, documentation, and systems.
- Review and approve batch records, deviation reports, and change controls.
- Investigate quality deviations and implement corrective and preventive actions (CAPAs).
- Collaborate with manufacturing, R&D, and regulatory affairs teams on quality-related matters.
- Prepare for and participate in regulatory inspections and external audits.
- Monitor key quality metrics and provide reports to senior management.
- Develop and deliver quality assurance training to relevant personnel.
- 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 7 years of experience in pharmaceutical quality assurance or quality control.
- In-depth knowledge of GMP, ICH guidelines, and other relevant regulatory standards.
- Proven experience in conducting internal audits and managing CAPAs.
- Strong analytical and problem-solving skills with meticulous attention to detail.
- Excellent written and verbal communication skills.
- Proficiency in using QMS software and documentation systems.
- Ability to work independently and manage multiple projects in a remote setting.
- Experience in the pharmaceutical industry is essential.
- Professional certifications (e.g., CQAP, CSQP) are a plus.
This advertiser has chosen not to accept applicants from your region.
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