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QA Operations Specialist - Pharma (Try & Hire)

Remote: 
Full Remote
Contract: 
Experience: 
Mid-level (2-5 years)
Work from: 

Offer summary

Qualifications:

Degree in Pharmacy or related Master's, At least 3 years in QA Operations, Knowledge of biological drugs or sterile products, Experience with vaccines is a plus, Fluency in English, both written and spoken.

Key responsabilities:

  • Coordinate QA Operations activities with external partners
  • Ensure thorough documentation of QA activities
  • Manage change control processes with internal teams
  • Prepare documentation for product release
  • Assist in development of GxP training programs
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Michael page Human Resources, Staffing & Recruiting Large https://www.page.com/
5001 - 10000 Employees
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Job description

  • Growing company|Entrepreneurial mindset

About Our Client

Our client is a growing biopharmaceutical company.

Job Description

We are seeking a highly motivated QA Operations Specialist to join our client's team. This role is critical in ensuring quality standards are met in collaboration with manufacturing and distribution partners.

Key Responsibilities

  • Coordinate and oversee QA Operations activities with external manufacturing and distribution partners.
  • Maintain accurate tracking and processing of the company's QA operations.
  • Ensure thorough and compliant documentation of QA activities.
  • Support the Responsible Person (RP) in managing GxP-related projects.

Main Tasks

  • Manage and resolve quality complaints.
  • Handle change control processes with both partners and internal teams.
  • Oversee and manage deviations from partners and intra-company processes.
  • Prepare and verify documentation for product release and shipment.
  • Ensure proper documentation, record-keeping, and archiving of quality records.
  • Coordinate Quality Technical Agreements (QTAs) and assist in audit processes.
  • Compile monthly Quality KPIs for management reporting.
  • Assist in the development and implementation of GxP training programs.
  • Contribute to the continuous improvement of the Quality Management System (QMS).
  • Provide support for additional quality-related projects as needed.

The Successful Applicant

  • Degree in Pharmacy, or a related Master's in pharmaceutical sciences (or equivalent).
  • At least 3 years of experience in QA Operations within the pharmaceutical industry.
  • Proven experience working with external partners and QA systems (a plus).
  • Knowledge of biological drugs or sterile products. Experience with vaccines is an advantage.
  • Fluency in English, both written and spoken.
  • Strong understanding of Good Manufacturing Practices (GMPs) and Good Distribution Practices (GDPs).

What's on Offer

  • Be part of a fast-paced, innovative environment.
  • Work alongside experienced professionals and external partners in a hybrid setup.

Contact: Fanny Sion

Quote job ref: JN-102024-6552090

Required profile

Experience

Level of experience: Mid-level (2-5 years)
Industry :
Human Resources, Staffing & Recruiting
Spoken language(s):
EnglishEnglish
Check out the description to know which languages are mandatory.

Other Skills

  • Problem Solving
  • Verbal Communication Skills
  • Analytical Thinking
  • Collaboration
  • Quality Assurance

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