QA Chemist

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

The Role:

You will be a member of Pfizer’s dedicated and highly effective Quality Assurance team. You will evaluate and review Pfizer’s 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 Active Pharmaceutical Ingredients. In the relevant cases you will approve investigations and change control activities to ensure compliance with configuration management policies.

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.

This position is a 23-month contract role.

The Location:

The Pfizer Ringaskiddy API Site is located at the mouth of Cork Harbour, approx. 12 Km south from Cork city where 850 colleague are employed in both on site and hybrid roles. It’s the main global new product launch site for small molecule medicine at Pfizer as well as manufacturing a wide range of patented and non-patented medicines. It has number of manufacturing facilities on the campus as well as state of the art analytical testing and process research laboratories. The campus has an excellent reputation for colleague development and progression.

Role Responsibilities

• 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.
• Accurately communicate Supply/Operational needs/perspectives as well as Quality Operations (QO) perspectives.
• Suggest improvements and conduct continuous improvement activities.
• Assess a wide range of Change Control activities to determine potential Quality and Operational Good Manufacturing Practices {also cGMP} impacts.
• Investigate, document Quality Assurance related deviations and escalate issues as appropriate to the Quality Assurance Lead in a timely manner.

Documentation Responsibilities

• Maintain regulatory compliance in accordance with current Good Manufacturing Practices. Provide Quality Review and oversight of site documentation related to the operation of manufacturing facility/laboratory to ensure compliance. Review and approval of validation documents Process, cleaning & method validation. Develop annual product quality review plan and complete annual reviews as per schedule. Provide quality oversight of purchase material qualification activities and GMP service providers Support audits of suppliers and GMP service providers including providing vendor information to RQA and performing vendor audits Prepare and approve quality agreements with applicable suppliers Review and approve master batch records and executed batch records to assure compliance with regulatory standards and regulatory filing.

Must-Have

• Bachelor's Degree
• 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

 
Work Location Assignment: Flexible

This position is a 23-month contract role.

Additional Information 

• In order to be considered for this position in Ireland you need to be legally eligible to work in Ireland. 

• Please note there is no relocation support available for this position 

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How to apply 

• Make a difference today, all suitable candidates should apply with CV below.  We are looking forward to hearing from you! 

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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. 

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. 

Quality Assurance and Control#LI-PFE