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