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Qualified Person
hace 2 meses
This job is with MSD, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community.
Please do not contact the recruiter directly.
Job Description Qualified Person Join our team at our Salamanca facility as a Qualified Person.
This role is integral to ensuring that our product quality activities comply with GMP regulations, corporate policies, and established regulatory requirements.
As a Qualified Person, you will make critical decisions for bulk, intermediate, and finished veterinary medicinal products.
You will also have the opportunity to work cross-functionally with other departments and functions to successfully deliver high impact projects and objectives for our organization.
Responsibilities Making critical decision for bulk, intermediate and finished veterinary medicinal products.
Ensuring that each batch of veterinary medicinal product has been manufactured and controlled in accordance to GMP and other applicable drug legislation.
Reviewing and approving PQR reports related to the products within area of oversight.
Working in close collaboration with partners in operations, process engineering and planning to review and evaluate complaints and deviations related to the products within area of oversight.
Approving, tracking, assessing, completing and extending of CAPAs.
Supporting change management related to the manufacture of the products within area of oversight.
Reviewing and approving validation and qualification documentation.
Creating, reviewing and approving SOPs, specifications and test methods, manufacturing and packaging protocols.
Supporting the execution of site and quality related projects related to the product in area of oversight as well as other continuous improvement opportunities.
Being responsible for Quality Assurance oversight of key quality activities.
Being responsible for contacting with other quality units within the company (e.g.
Regulatory).
Qualifications Required Minimum BS degree in pharmacy, or other 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 their organization.
Demonstrated experience with inspections and regulatory authorities.
Advanced knowledge in 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 test.
Fluency in Spanish.
Business Proficiency in English.
Preferred Already has attained qualified person certification within Spain.
Experience with managing contract manufacturers or external partners.
Experience in the manufacture of biological and sterile products.
Fluency in English.
Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities.
All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.
No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place.
Where agency agreements are in place, introductions are position specific.
Please, no phone calls or emails.
Employee Status: Regular Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Hybrid Shift: Valid Driving License: Hazardous Material(s): Job Posting End Date: 10/8/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date.
Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Job Posting End Date: 10/08/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date.
Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID: R314753 #LI-DNI
