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