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 SOQ 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.

Job Focus

The SOQ Senior Associate will be responsible for supporting, maintaining, and implementing the Quality Management System (QMS) at the Pfizer Country Offices (PCOs) to ensure compliance with both Pfizer and Regulatory Authority expectations.

The SOQ Senior Associate will work closely with relevant stakeholders, such as Global Regulatory Sceinces (GRS), Global Supply Chain (GSC), Medical, and PGS Sites or ESOQ to ensure that the appropriate quality standards and systems are implemented and maintained for the product supply operations of the Pfizer business.

How You Will Achieve It

1. Quality Assurance & Inspections and Internal Audit

• Lead and / or participate in deviation investigations using appropriate tools and works with cross-functional teams to implement CAPAs.
• Notify Management of significant concerns or deviations within the QMS
• Management of Investigation and CAPA
• Assists with the timely implementation of applicable quality management systems (SOP) within the PCO.
• Assists with ensuring initial and continuous training programs are implemented and maintained for all relevant PCO colleagues.
• Ensure planned, permanent & temporary changes of GMP / GDP related activities & systems are managed & documented appropriately. Ensures change actions are completed as per agreed timelines.
• Collects key quality performance indicators, evaluates and highlights any significant trends and identifies actions.
• Monitor key performance indicators (KPIs) of the QMS, evaluate and highlight significant trends, and identify actions. Leads and / or participate in Quality Review Meetings as required.
• Provides support in the preparation and coordination of any Health Authority (HA) inspection and / or internal Pfizer audits of GMP / GDP activities in the PCO.
• Work with local cross functional team to define appropriate action plans to address the inspection / audit observation and tracks action implementation within the agreed timelines.
• Participates in the self-inspection program as an auditor and / or auditee, as required.
• Leads and / or participate in the Quality Risk Management program for the consistent application, documentation and communication of risks to product quality / patient safety in support of GxP activities under the remit of SOQ.

2. Local Product Disposition & Resolution of Product Quality

• Perform the local release process of Products under the PCOs distribution license, as required.
• Supports the coordination of all product repackaging and / or relabelling activities in the PCO and at the third-party packaging site. Review and approve documentation related to the repackaging and / or relabelling of Pfizer product, as required.
• Actions Quarantine Alert Notifications promptly, as needed
• Ensures quarantine shipments are managed compliantly
• Provides support for any market action operations
• Complaint handling

3. Supplier Quality Management

- Execute tasks associated with the management of GxP suppliers including qualification and quality oversights

4. Deviation Management

• Accountable for managing/owning quality investigation records through initiation, the investigation process including root cause analysis and PHP, to record close. This encompasses gathering relevant details and writing the investigation. Ensuresthe investigations are conducted thoroughly, within required timelines and to compliance requirements including ensuring the adequacy of root cause analysis and appropriateness of communications and resulting actions.
• Leads the investigation team in the development of appropriate Corrective and Preventative Actions (CAPA) and assign completion dates to action owners that ensure actions are progressed quickly to completion, including creation of Planned Temporary Deviations as required.

5. Leadership skills

- Facilitates development and execution of project initiatives consistent with SOQ Purpose Blueprints.

-Development and maintenance of Quality Culture, within the team and organization.

Qualifications

Must-Have

• Bachelor of Science, Pharmacy (Licensed)
• A minimum of 3 years in the pharmaceutical industry, preferably in a quality role
• Strong analytical and technical skills
• Demonstrated ability to influence, when necessary, particularly with stakeholders and external parties.
• A track record of continuous improvement and balancing efficiencies and effectiveness in processes
• 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

Preferred Qualifications

• Ability to progress work activities with oversight
• 3-8 years of pharmaceutical experience with solid experience in GMP/GDP Quality
• Project management, administrative, with technical capabilities
• Strong and effective verbal and written communication skills
• Attention to details
• Quality or compliance experience preferred
• Scientific background in Life Sciences, Regulatory Affairs, or higher degree preferred
• Training and proficiency in root cause analysis methodology preferred· Project management, administrative, and technical capabilities
• Strong organizational skills and ability to prioritize multiple projects and meet targeted deliverables and deadlines
• Ability to adapt to changing situations and work well under pressure

 
Work Location Assignment: Hybrid

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers.


Quality Assurance and Control