Are you passionate about maintaining the highest standards in pharmaceutical quality assurance? We are seeking a seasoned Senior Quality Specialist to join our dynamic team and contribute to the excellence of our pharmaceutical operations.
As a Senior Quality Specialist, you will be responsible for;
* Quality Assurance Leadership: Lead quality assurance initiatives and ensure compliance with regulatory standards such as FDA, EMA, and other relevant authorities.
* Process Improvement: Identify areas for process optimization and implement strategies to enhance efficiency and quality across all stages of pharmaceutical production.
* Documentation and Compliance: Oversee documentation processes, including SOPs, batch records, and regulatory submissions, to ensure accuracy, completeness, and compliance with industry standards.
* Quality Control Oversight: Collaborate with cross-functional teams to develop and implement robust quality control measures, including risk assessments, investigations, and corrective/preventive actions.
* Training and Development: Provide guidance and training to team members on quality assurance protocols, regulatory requirements, and best practices within the pharmaceutical industry.
* Audit Preparation and Management: Coordinate internal and external audits, participate in inspections, and facilitate the resolution of audit findings to maintain compliance and uphold quality standards.
Requirements:
* Bachelor's degree in Pharmacy, Chemistry, Biology, or related field; advanced degree preferred.
* Minimum of 5 years of experience in quality assurance within the pharmaceutical industry, with a strong understanding of GMP, GLP, and GCP regulations.
* Proven track record of implementing quality systems, managing deviations, and driving continuous improvement initiatives.
* Excellent communication, problem-solving, and leadership skills.
* Experience with regulatory inspections and audits is highly desirable.
* Certification in Quality Management (e.g., Six Sigma, Lean, ASQ) is a plus.
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Job Overview
ID:
1083917
Date Posted:
Posted 2 days ago
Expiration Date:
01/05/2024
Location:
Swindon
Competitive
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