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Manufacturing Quality Assurance Specialist
hace 1 mes
**Overview of MSD:**
Msd is a global leader in the development and manufacturing of pharmaceuticals, committed to delivering innovative solutions that improve human health. Our Salamanca facility plays a critical role in our operations, producing high-quality veterinary medicinal products that meet the highest standards of quality and regulatory compliance.
**Salary Range:** $80,000 - $110,000 per year,
dependent on qualifications and experience.
**Job Description:**
We are seeking an experienced Manufacturing Quality Assurance Specialist to join our team at our Salamanca facility. As a key member of our quality assurance team, you will be responsible for ensuring that our product quality activities comply with GMP regulations, corporate policies, and established regulatory requirements. Your expertise will play a critical role in making critical decisions for bulk, intermediate, and finished veterinary medicinal products, as well as ensuring that each batch of product has been manufactured and controlled in accordance with GMP and other applicable drug legislation.
**Key Responsibilities:**
- Make critical decisions for bulk, intermediate, and finished veterinary medicinal products.
- Ensure that each batch of veterinary medicinal product has been manufactured and controlled in accordance with GMP and other applicable drug legislation.
- Review and approve PQR reports related to products within your area of oversight.
- Work closely with partners in operations, process engineering, and planning to review and evaluate complaints and deviations related to products within your area of oversight.
- Approve, track, assess, complete, and extend CAPAs.
- Support change management related to the manufacture of products within your area of oversight.
- Review and approve validation and qualification documentation.
- Create, review, and approve SOPs, specifications, and test methods, manufacturing, and packaging protocols.
- Support the execution of site and quality-related projects related to products in your area of oversight, as well as other continuous improvement opportunities.
**Requirements:**
- Bachelor's degree in pharmacy or another degree that has attained Qualified Person certification within Spain.
- Minimum 5 years' experience in the pharmaceutical industry.
- Majority of experience supporting pharmaceutical manufacturing operations, with a mix of operations and quality experience.
- Proven track record of working cross-functionally with other departments and functions to successfully deliver high-impact projects and objectives for your organization.
- Demonstrated experience with inspections and regulatory authorities.
- Advanced knowledge of GMP and applicable Pharmacopoeias.
- Advanced knowledge of Quality System tools (change controls, deviations management, out of specifications, equipment qualification, process validation, product validation, elaboration of risk analysis, annual product reviews, claims, audits, self-inspections, etc.).
- Advanced knowledge in the processes of product manufacturing, equipment, and facilities.
- Knowledge in quality control tests.
**Benefits:**
Msd offers a competitive salary and benefits package, including medical insurance, retirement savings plan, and paid time off. We also provide opportunities for professional growth and development through training programs and mentorship. Additionally, we offer flexible work arrangements and a collaborative work environment that supports work-life balance.
**Location:**
This position is located at our Salamanca facility in Spain. You will have the opportunity to work in a dynamic and fast-paced environment, collaborating with a talented team of professionals who share your passion for delivering high-quality products.
