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 a Senior Associate, your knowledge and skills will contribute towards the goals and objectives of the team.  Your focus and ability to meet team targets will help in completing critical deliverables. Your innovative use of communication tools and techniques will facilitate in explaining difficult issues and establishing consensus between teams.

It is your hard work and focus that will make Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It

Activities during regulatory lifecycle managements process (BOH queries, BOH renewals, annual report, product recertifications, Post Market Surveillance, changes) acting as compliance network members (CNM) 

Supports the QA implementation activities for the site for the compliance with 21 CFR Part 4-Regulation of Combination Products, subpart A-cGMP Requirements for Combination Products and subpart B-PMSR for combination products 

Review and evaluate incidents related to the products manufactured, imported, and packaged for the surveillance system and process available for communicating them to the health authorities, competent authorities, or Notify Body if applicable. 

Preparation and supervision of the documentation required for the certification of In vitro Device and support the preparation/updated of the technical documentation for IVD products. 

Preparation and supervision of the documentation required for the reception and inspection of imported medical devices (prefilled syringes). 

Supports activities during regulatory change management process acting as compliance network members (CNM) 

Supports activities during regulatory lifecycle managements process (BOH queries, BOH renewals, annual report, product recertifications, Post Market Surveillance) acting as compliance network members (CNM) 

Manage routine Investigations Quality Systems (laboratory and manufacturing). 

Review and participate in Quality Risk Management process 

Ensure compliant site Quality Systems.  

Assist during regulatory inspection as requested by Management. 

Apply continuous improvement Tools to the daily operations 

Understanding of applicable industry standards across the site organization and support the implementation of these standards. 

Contribute to the completion of projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.

Suggest improvements and conduct continuous improvement activities.

Qualifications

Must-Have

• Bachelor's Degree in Pharmaceutical science
• 3+ years' experience
• Experience in Quality administered systems
• Knowledge of current Good Manufacturing Practices and the applicable GxP regulations and standards
• Proactive approach and strong critical thinking skills
• Must be able to work in a team environment within own team and interdepartmental teams
• Excellent communication and interpersonal skills
• Good working knowledge of Microsoft Excel and Word

Nice-to-Have

• Master's degree and relevant pharmaceutical experience
• Willing to lead by example and jump right in, desire to get to root cause, collaborative and active listener
• Effectively manages stressful situations, able to focus on task at regardless of circumstances and stress induced pressure

Purpose 

Breakthroughs that change patients' lives... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.  

Digital Transformation Strategy

One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.

Flexibility  

We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let’s start the conversation!  

Equal Employment Opportunity 

We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.

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