Quality Control Microbiology Senior Analyst
We’re in relentless pursuit of breakthroughs that change patients’ lives. We innovate every day to make the world a healthier place.
To fully realize Pfizer’s purpose – Breakthroughs that change patients’ lives – we have established a clear set of expectations regarding “what” we need to achieve for patients and “how” we will go about achieving those goals.
Pfizer Global Supply proudly shoulders the responsibility of manufacturing and distributing our wide-ranging pharmaceutical products.
Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues.
Transforming Delivery of high quality products
Pfizer, We are one
PGS - Manufacture the Future
JOB DESCRIPTION
1.General Information:
Job Title: Quality Control Microbiology Senior Analyst
Department: Quality
Position Reports to: Quality Control Manager
2. Job Purpose:
To maintain regulatory compliance through established programs for laboratory testing, maintenance, training, and SOPs within Quality Control.
3. Reporting Structure:
Quality Control Senior Manager
Quality Control Manager
Quality Control Senior Analyst
4. Job Responsibilities:
* Provide feedback to QC Microbiology group and Manufacturing areas on trends that have been identified within the quality system.
* Initiate and follow up any non-conformances with manufacturing.
* Support investigations- ensure that all activities related to the investigation and resolution of QC Microbiology related non-conformances are performed in a timely manner and in compliance with procedures and regulatory requirements.
* Prepare and approve area documentation (e.g. SOP’s, Reports, Protocols).
* Perform Microbiological testing analysis on, but not limited to, finished drug product, in process materials, stability samples and environmental monitoring.
* Complete documentation associated with analytical results in a timely manner.
* Co-ordinating /adjusting schedules in line with priorities.
* Conduct laboratory audit walkdowns.
* Support key meetings as required.
* Maintain inspection readiness, support inspections from regulatory agencies.
* Support the New Product Introduction Program (NPI) as required.
* Support any validation, technology transfer and qualification of test methods and processes as required.
* Troubleshoot laboratory methods and instrument problems/qualification of equipment
* Manage Change controls for the team.
* Ensure training compliance within the assigned work area and QC.
* Adhere to safety systems within the laboratory and on site.
* Perform and assist in additional duties as directed.
5. Education/Experience:
To be successful in this role the following are prerequisites to application:
* Third level Qualification in Science, Engineering or equivalent is preferred though not essential. Exceptions may be considered where relevant skills/experience and correct attitude and behaviours exist (this may be supplemented by further education in parallel).
* 3+ years experience in a GMP QC Microbiology environment is essential.
* Experience in GMP environmental monitoring is desirable.
* Excellent communication and interpersonal skills.
* This job description indicates the general nature and level of work expected of the incumbent. It is not designed to cover or contain a comprehensive listing of all activities, duties or responsibilities required of the incumbent. Incumbents may be asked to perform other duties as required.
* Demonstrate the Pfizer values.
* Adhere to all HR Policies as appropriate.
* Personal Development plans focusing on the 70:20:10 guidelines.
* CI tools/- capability is a key building block for learning & development - Trained and M1 certified.
* Proactive engagement with key stakeholders.
* Best practices developed and shared with other teams /sites.
* Best practices actively sought and copied.
* Proactive & effective communication within and across shifts.
* Ability to work in a team environment within own team and interdepartmental teams
Working Patterns and Duration:
Day based role: Monday to Friday.
Work Location Assignment:On Premise( with the potential for hybrid work in the future*, subject to availability*)
All applicants must have relevant authorisation to live and work in Ireland.
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
How to apply
Make a difference today, all suitable candidates should apply with CV below. We are looking forward to hearing from you!
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.
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.
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.
Disability Inclusion
Our mission is unleashing the power of all our people and we are proud to be a disability inclusive employer, ensuring equal employment opportunities for all candidates. We encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments to support your application and future career. Your journey with Pfizer starts here!
JOB DESCRIPTION
1.General Information:
Job Title: Quality Control Microbiology Senior Analyst
Department: Quality
Position Reports to: Quality Control Manager
2. Job Purpose:
To maintain regulatory compliance through established programs for laboratory testing, maintenance, training, and SOPs within Quality Control.
3. Reporting Structure:
Quality Control Senior Manager
⇧
Quality Control Manager
⇧
Quality Control Senior Analyst
4. Job Responsibilities:
* Provide feedback to QC Microbiology group and Manufacturing areas on trends that have been identified within the quality system.
* Initiate and follow up any non-conformances with manufacturing.
* Support investigations- ensure that all activities related to the investigation and resolution of QC Microbiology related non-conformances are performed in a timely manner and in compliance with procedures and regulatory requirements.
* Prepare and approve area documentation (e.g. SOP’s, Reports, Protocols).
* Perform Microbiological testing analysis on, but not limited to, finished drug product, in process materials, stability samples and environmental monitoring.
* Complete documentation associated with analytical results in a timely manner.
* Co-ordinating /adjusting schedules in line with priorities.
* Conduct laboratory audit walkdowns.
* Support key meetings as required.
* Maintain inspection readiness, support inspections from regulatory agencies.
* Support the New Product Introduction Program (NPI) as required.
* Support any validation, technology transfer and qualification of test methods and processes as required.
* Troubleshoot laboratory methods and instrument problems/qualification of equipment
* Manage Change controls for the team.
* Ensure training compliance within the assigned work area and QC.
* Adhere to safety systems within the laboratory and on site.
* Perform and assist in additional duties as directed.
5. Education/Experience:
To be successful in this role the following are prerequisites to application:
* Third level Qualification in Science, Engineering or equivalent is preferred though not essential. Exceptions may be considered where relevant skills/experience and correct attitude and behaviours exist (this may be supplemented by further education in parallel).
* 3+ years experience in a GMP QC Microbiology environment is essential.
* Experience in GMP environmental monitoring is desirable.
* Excellent communication and interpersonal skills.
* This job description indicates the general nature and level of work expected of the incumbent. It is not designed to cover or contain a comprehensive listing of all activities, duties or responsibilities required of the incumbent. Incumbents may be asked to perform other duties as required.
6. People / Values Non-People Leaders:
* Demonstrate the Pfizer values.
* Adhere to all HR Policies as appropriate.
* Personal Development plans focusing on the 70:20:10 guidelines.
* CI tools/- capability is a key building block for learning & development - Trained and M1 certified.
* Proactive engagement with key stakeholders.
* Best practices developed and shared with other teams /sites.
* Best practices actively sought and copied.
* Proactive & effective communication within and across shifts.
* Ability to work in a team environment within own team and interdepartmental teams
Working Patterns and Duration:
Day based role: Monday to Friday.
Work Location Assignment:On Premise( with the potential for hybrid work in the future*, subject to availability*)
All applicants must have relevant authorisation to live and work in Ireland.
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
How to apply
* Make a difference today, all suitable candidates should apply with CV below. We are looking forward to hearing from you!
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.
Disability Inclusion
Our mission is unleashing the power of all our people and we are proud to be a disability inclusive employer, ensuring equal employment opportunities for all candidates. We encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments to support your application and future career. Your journey with Pfizer starts here!
Quality Assurance and Control
Breakthroughs that change patients’ lives
Research confirms what intuition tells us: that purpose-driven companies perform better, are more innovative, attract and retain the best people, and know how to unleash the power of those people. Pfizer’s purpose—Breakthroughs that change patients' lives—fuels everything we do and reflects our passion for building on our legacy as one of the greatest contributors of good to the world.
Each word in our purpose has meaning and reflects the value we strive to bring to patients and society:
“Breakthroughs” - These are the innovations, scientific and commercial, that we seek to deliver every day. All colleagues, regardless of role, level or location, strive for breakthroughs every day.
“Change” - We want to do more than simply improve patients’ medical conditions; we want to dramatically change their lives for the better.
“Patients’ lives” - We consider not only patients, but everyone they touch—including their families, caregivers, and friends—and everything they love to do. It’s an intentionally holistic view.
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.
Every decision we make and every action we take is done with the patient in mind—and to nurture an environment where breakthroughs can thrive.
Our Values
To fully realize Pfizer’s purpose, we have established a clear set of expectations regarding “what” we need to achieve for patients and “how” we will go about achieving those goals.
The “how” is represented by four simple, powerful values—courage, excellence, equity, and joy—that define our company and our culture.
Courage: Breakthroughs start by challenging convention, especially in the face of uncertainty or adversity. This happens when we think big, speak up, and are decisive.
Excellence: We can only change patients’ lives when we perform at our best together. This happens when we focus on what matters, agree who does what, and measure our outcomes.
Equity: We believe that every person deserves to be seen, heard, and cared for. This happens when we are inclusive, act with integrity, and reduce healthcare disparities.
Joy: We give ourselves to our work, but it also gives to us. We find joy when we take pride, recognize one another, and have fun.
Pfizer Global Supply proudly shoulders the responsibility of manufacturing and distributing our wide-ranging pharmaceutical products.
With an unwavering commitment to ensuring the availability and accessibility of these life-saving medications, we play a pivotal role in reaching patients, healthcare professionals, and markets across the globe.
Our network of state-of-the-art manufacturing facilities, strategically located distribution centers, and streamlined logistics systems enables us to deliver Pfizer's medicines with utmost efficiency and reliability, making a tangible difference in patients' lives worldwide.
Benefits at Pfizer
Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues. Our Pay for Performance Philosophy and Practices reward colleagues based on the contributions they make to our business.
Our Competitive Benefits Programs help our colleagues by:
* Promoting Health and Wellness to help colleagues maintain and improve their physical and mental wellbeing. Pfizer offerings include health and disability insurance, preventative health programs, medical screenings, free or reduced-cost vaccinations, discounts on Pfizer products, mental health support, nutrition and fitness counseling and more.
* Strengthening Colleagues’ Financial Security by providing company contributions to retirement plans, life insurance and financial planning education to help colleagues achieve their financial goals.
* Providing Benefits and Time off for the Moments that Matter to ensure Pfizer colleagues have the time away from the office to recharge, recover and return to work as the best version of themselves. Vacation, Holiday time and Sick time are just the beginning, with a 12 week parental leave policy for both parents of a new born, 10 day of caregiver leave for those times when your family needs you whether it’s a child, spouse or parent, bereavement leave, and additional country-specific programs.
* And so much more, depending on your country and site, Pfizer offers childcare facilities or discount programs, on-site health and/or fitness centers, movement and mindfulness solutions, “Log in for your Day” work flexibility and so much more.
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