2 Principal Pharmaceutical Quality Assurance Specialist Remote jobs in whatjobs
Principal Pharmaceutical Quality Assurance Specialist (Remote)
Posted 20 days ago
Job Viewed
Job Description
Our client, a globally recognized leader in the Pharmaceutical industry, is seeking an experienced Principal Pharmaceutical Quality Assurance Specialist to join their esteemed team. This is a critical, fully remote position that plays a pivotal role in ensuring the highest standards of quality and compliance across all pharmaceutical operations. The ideal candidate will possess an in-depth understanding of Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and regulatory requirements across key markets. You will be responsible for developing, implementing, and maintaining robust quality management systems, conducting internal and external audits, and driving continuous improvement initiatives. This role requires exceptional attention to detail, strong analytical skills, and the ability to effectively manage complex quality assurance processes from a remote setting.
Responsibilities:
Qualifications:
Responsibilities:
- Develop, implement, and manage comprehensive quality assurance programs and systems in compliance with regulatory standards (e.g., FDA, EMA).
- Lead and conduct internal audits of manufacturing sites, laboratories, and distribution centers to ensure adherence to GMP, GLP, and other relevant regulations.
- Oversee the investigation of deviations, CAPA (Corrective and Preventive Actions) implementation, and change control processes.
- Review and approve critical quality documents, including batch records, validation protocols, and SOPs.
- Provide expert guidance and support to cross-functional teams on quality-related matters.
- Participate in external regulatory inspections and host regulatory auditors.
- Drive continuous improvement initiatives to enhance product quality and operational efficiency.
- Develop and deliver training programs on quality assurance best practices.
- Monitor industry trends and regulatory updates, ensuring the company remains compliant.
- Manage quality agreements with external partners and suppliers.
Qualifications:
- Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science field.
- Minimum of 10 years of progressive experience in Quality Assurance within the pharmaceutical industry.
- Extensive knowledge of pharmaceutical manufacturing processes, quality control, and regulatory affairs.
- Proven experience in leading and conducting GMP audits.
- Strong understanding of ICH guidelines and global regulatory requirements.
- Excellent analytical, problem-solving, and decision-making skills.
- Exceptional attention to detail and commitment to quality.
- Superior written and verbal communication skills.
- Ability to work independently and manage multiple complex projects effectively in a remote environment.
- Experience with quality management software (e.g., TrackWise, LIMS).
- Must have a reliable internet connection and a suitable home office setup for this fully remote role .
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Principal Pharmaceutical Quality Assurance Specialist (Remote)
Posted 3 days ago
Job Viewed
Job Description
Our client is seeking a highly experienced and meticulous Principal Pharmaceutical Quality Assurance Specialist to join their elite, fully remote team. This critical role will be instrumental in upholding and enhancing the company's commitment to pharmaceutical quality and regulatory compliance. You will be responsible for developing, implementing, and maintaining robust quality management systems (QMS) that adhere to global regulatory standards, including GMP, ICH, and FDA guidelines. Your expertise will be vital in conducting internal and external audits, reviewing batch records, investigating deviations and CAPAs (Corrective and Preventive Actions), and ensuring the integrity of pharmaceutical products throughout their lifecycle. This position demands a deep understanding of pharmaceutical manufacturing processes, analytical testing, validation protocols, and risk management principles. You will work closely with R&D, manufacturing, regulatory affairs, and other departments to ensure that all quality-related activities are executed with precision and efficiency. As a remote-first specialist, you must possess exceptional analytical and problem-solving skills, coupled with outstanding written and verbal communication abilities to effectively collaborate with global teams and stakeholders. The ability to interpret complex regulatory documents, conduct thorough risk assessments, and drive continuous improvement initiatives is paramount. We are looking for a proactive, detail-oriented individual with a proven track record in pharmaceutical quality assurance, preferably with experience in sterile products, biologics, or complex drug formulations. You will lead quality-focused projects, mentor junior QA personnel, and contribute significantly to the overall quality culture of the organization. This is a remote role requiring significant autonomy and strong organizational skills. The job location for reference, although this position is fully remote, is **Mlolongo, Machakos, KE**.
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