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