Quality Assurance Specialist
1 month ago
Position Overview:
The Quality Assurance Specialist is essential in upholding the utmost standards of product integrity and regulatory compliance within a prominent pharmaceutical organization.
This role is crucial to the company's commitment to excellence in every product.
Company Profile:
Our client is an expanding entity in the pharmaceutical industry, recognized for its dedication to quality and innovation, holding a substantial market position and a robust industry presence.
Located in a collaborative environment, the company fosters a culture where team members are encouraged to develop and contribute meaningfully.
Key Responsibilities:
- Assist in the creation, maintenance, and enhancement of the Quality Management System (QMS).
- Auditing:
Conduct and follow up on both internal and external audits.
- Initiate and evaluate deviations and complaints.
- Verify qualifications and validations.
- Draft management, quality-related, and technical documentation.
- Execute and oversee quality-related activities, including mock recalls, management of returned goods/counterfeit products, monitoring manufacturing processes, stability studies, and Product Quality Reviews (PQRs).
- Supervise the accurate completion of work documentation.
- Maintain up-to-date qualification and approval status of suppliers.
- Manage the transfer of products received from suppliers to sellable stock based on respective Certificates of Analysis and approved packaging.
- Prepare and oversee Quality Technical Agreements (QTAs) with suppliers, distributors, and warehouses.
- Participate in audits conducted by third parties or regulatory authorities.
- Ensure quality oversight of manufacturing, storage, and transportation operations.
- Conduct work in compliance with regulations and permits.
- Provide support for various operational challenges related to customer service and supply chain management.
Candidate Profile:
A successful Quality Assurance Specialist should possess:
- Experience in a similar role with a proven track record in quality assurance within the pharmaceutical sector.
- In-depth knowledge of quality assurance methodologies and best practices.
- Strong analytical skills and attention to detail.
- Excellent communication abilities for reporting quality-related matters and solutions.
- Proficient systems knowledge and IT capabilities.
Compensation and Benefits:
- Competitive salary range.
- Initial contract with potential for permanent placement.
- Flexible working arrangements.
- Pension benefits and the chance to be part of a growing organization.
- Generous vacation leave and a positive, collaborative workplace culture.
This role offers a unique opportunity to significantly contribute to maintaining the company's esteemed reputation for quality and excellence in the industry.
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