Job Purpose
The Quality Assurance Specialist supports the internal stakeholders, including the ISO 17025 certified lab, research and development team, and manages quality-related activities including CMO qualification, outsourced activities, and quality management system tasks. This role is crucial in ensuring the release of high-quality products and maintaining compliance with regulatory standards.
Duties & Responsibilities
The key responsibility for the ... Visa mer
Job Purpose
The Quality Assurance Specialist supports the internal stakeholders, including the ISO 17025 certified lab, research and development team, and manages quality-related activities including CMO qualification, outsourced activities, and quality management system tasks. This role is crucial in ensuring the release of high-quality products and maintaining compliance with regulatory standards.
Duties & Responsibilities
The key responsibility for the role includes:
ISO 17025 Quality Support: Ensure compliance with ISO 17025 standards in laboratory operations and testing procedures.
Organize and conduct internal and external meetings regarding complaints, reports and deviations
Reviewing the validating certificates on ISO 17025 certified equipment
Draft and update instructions, reports such as validation reports and nonconformities within the quality system of the laboratory
Certified QC Lab Support:
Quality Assurance Consultation: Provide expert QA consultation to the QC lab, addressing any quality assurance-related questions.
Scientific Guidance: Offer scientific guidance to the QC lab to ensure accurate and reliable testing results.
Stability Assessment: Address stability-related questions and ensure proper stability testing procedures are followed.
Equipment Management: Assist with equipment management activities, including calibration, maintenance, and validation
Support for Internal Stakeholders:
Research and Development Support: Collaborate with R&D teams (Product and Application (P&A) team) to ensure quality standards are met in all research activities.
Supply Chain department: Work closely with the supply chain department to ensure quality standards are maintained throughout the procurement and distribution processes.
Sales activates: Assist the sales department in addressing quality-related inquiries and ensuring customer satisfaction.
Customer Support:
Complaint Handling: Address and resolve customer complaints related to product quality, ensuring timely and effective communication.
Quality Inquiries: Respond to customer inquiries regarding product quality (e.g. ingredients, methods, suppliers, specifications, stability data and packaging materials) and provide necessary information and support, including providing input to customer questionnaires.
CMO Qualification: Evaluate and qualify Contract Manufacturing Organizations (CMOs) to ensure they meet quality standards.
Outsourced Activities: Monitor and manage quality aspects of outsourced activities to ensure compliance with company standards.
Quality Management System (QMS):
Deviation Handling: Investigate and resolve deviations in processes and procedures.
Change Control Management: Manage changes in processes, equipment, and documentation to ensure compliance. Communicate changes with external stakeholders by sending out Change Control requests to CMOs and to the customers.
Documentation Management: Maintain accurate and up-to-date documentation within the QMS.
Product Release: Oversee the release of products, ensuring they meet all quality and regulatory requirements.
Qualifications
Master’s degree in a related field (e.g., Chemistry, Biology, Quality Management).
Minimum of 3 years of experience in qualityform the food or supplement industry, preferably in an ISO 17025 certified environment.
Strong knowledge of quality management systems and regulatory requirements.
Proficiency in Microsoft Word and Excel.
Excellent analytical and problem-solving skills.
Effective communication and interpersonal skills.
Ability to work independently and as part of a team.
Fluent in English, both oral and written
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