Validation/Qualification Officer (CDD - 1 year contract)

Posted 12 Days Ago
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El Jadida
Hybrid
Mid level
Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical
We’re in relentless pursuit of breakthroughs that change patients’ lives.
The Role
As a Validation/Qualification Officer at Pfizer, you'll evaluate and review clinical and commercial drug batches, ensuring compliance with established standards and quality practices. Your role entails approving audit reports, deviations, and manufacturing records while contributing to quality assurance and process improvement initiatives. You'll work collaboratively within teams to maintain inspection readiness and support corrective actions in manufacturing operations.
Summary Generated by Built In

Why Patients Need You
Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.
What You Will Achieve
You will be a member of Pfizer's dedicated and highly effective quality assurance team. You will evaluate and review Pfizer's clinical and commercial batches of drugs. You will make sure that product and process documents match the specifications based on established sampling and statistical process control procedures. Your expertise will help in identifying deviations from established standards, in the manufacturing and packaging of products. In the relevant cases you will approve investigations and change control activities to ensure compliance with configuration management policies.
As an associate, your focus on the job will contribute in achieving project tasks and goals. Through your domain knowledge and commitment, you will create a collaborative teaming environment for your colleagues.
It is your hard work and commitment that will make Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve It

  • Contribute to the completion of complex projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.
  • Create, review and approve Good Manufacturing Practices {also cGMP} audit reports.
  • Review and approve Manufacturing and Packaging records to ensure that the information and documentation conforms to Pfizer policy and cGMP's.
  • Create, review and approve deviations and consistently produce quality work.
  • Accurately communicate supply, operational needs or Quality Operations (QO) perspectives and escalate issues with potential market or stability impact.
  • Ensure that all documents received in the batch release area reviewed for completeness and accuracy.
  • Provide Real Time Quality impact assessments and decisions on product and medical device issues, independently.
  • Maintain inspection readiness, support inspections from regulatory agencies & customers and improve quality assurance systems.
  • Participate in Green/Black belt projects, Right First Time (RFT) Improvement projects, Corrective Action / Preventative Action Effectiveness, etc. as appropriate.
  • Assist and support the manufacturing/packaging staff in detecting and solving compliance errors in real time during manufacturing and packaging operations.
  • Help to define appropriate action plans for improvement and follow-up and communicate action closures.
  • Lead/Participate in Quality Risk Management (QRM) assessments that gain approval through Site and Area Quality Operations (QO) Management.


Qualifications
Must-Have

  • Master's Degree
  • Experience in pharmaceutical industry
  • Experience in Quality administered systems
  • Sound knowledge of current Good Manufacturing Practices {part of GxP}
  • Ability to work in a team environment within own team and interdepartmental teams
  • Effective written and oral communication skills


Nice-to-Have

  • Experience at a manufacturing site
  • Experience of writing and managing deviations
  • Experience in Process, Cleaning & Holding time Validation,
  • Experience in Equipment & Utilities Qualification.


Work Location Assignment: On Premise
Location: El Jadida
Type of contract: 1 year contract (Temporary Contract/CDD)
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Quality Assurance and Control
#LI-PFE

The Company
Mumbai, Maharashtra
121,990 Employees
Hybrid Workplace
Year Founded: 1848

What We Do

Our purpose ensures that patients remain at the center of all we do. We live our purpose by sourcing the best science in the world; partnering with others in the healthcare system to improve access to our medicines; using digital technologies to enhance our drug discovery and development, as well as patient outcomes; and leading the conversation to advocate for pro-innovation/pro-patient policies.

Why Work With Us

We are the inventors, the problem solvers, the big thinkers — those who surmount any hurdle to deliver breakthrough medicines to the people who are counting on them the most.

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Pfizer Offices

Hybrid Workspace

Employees engage in a combination of remote and on-site work.

Typical time on-site: Not Specified
Chennai, IN
Mumbai, Maharashtra

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