The SOQ Senior Associate ensures compliance with quality standards, supports audits, manages supplier quality, and leads quality risk management initiatives.
- The Supply Operation Quality (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 local stakeholders, such as Global Regulatory Sciences (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 operation of the Pfizer India and neighboring market (Sri Lanka, Bangladesh, Nepal) business.
Quality Assurance & Inspections and Internal Audit
- Assists with the timely implementation of applicable quality management systems (SOPs) within the PCO.
- Assists with ensuring initial and continuous training programs are implemented and maintained for all relevant PCO colleagues.
- Ensures 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 participates 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 participates 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.
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 according to procedures, as required.
- Provides support for any market action operation in the PCO, as required.
- Complaint Handling - Perform Intake and Triage, issue correspondence letter as required. Acts as a contact point for Regulatory Agency/reporter in the PCO, as required.
- 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 which have the potential to impact product, regardless of release status. Where issues originate in the PCO, assist with the preparation of QRT meetings, where required. Assist with the implementation of local actions identified during QRT.
- Management of relevant corrective and preventative actions (CAPA)
Supplier Quality Management
- Execute tasks associated with the management of GxP Suppliers including qualification, quality oversight in accordance with internal and regulatory requirements for GxP activities.
- Assists with ensuring appropriate customer screening processes are in place to align with Pfizer and local regulations, as required.
- Assist with the coordination of RQA audits at the Supplier.
Leadership Skills
- Facilitate development and execution of objectives / projects consistent with SOQ Purpose Blueprint.
- Development and Maintenance of Quality culture, within the team and organisation.
Qualifications
- A minimum Tertiary Education in Science, Pharmacy or related discipline
- A minimum of 5 years in the pharmaceutical industry in a quality role
- Fluent in English (written and verbal)
- Experience in Quality administered systems.
- Excellent computer system skills - Word and Excel essential.
- Experience with electronic documentation control systems advantageous.
- Demonstrated ability to influence, when necessary, particularly with stakeholders and external parties.
- Experience in GMP, GDP and QMS.
- Technical writing and reporting
- Previoususe of Trackwise®, eQMS beneficial.
Competencies
- Scientific knowledge and strong analytical skills to make sound quality assessments of project strategy.
- GMP/GDP Knowledge. Trained and experienced in the total application of GMP/GDP.
- Auditing. Knowledge of Auditing procedures.
- Technical writing. Ability to lead a technical investigation and report to all levels of oganisation. Ability to write well-structured technical reports.
- Problem solving. Ability to use problem solving skills and tools to identify and eliminate problems as they arise.
- Takes initiative and ownership to deliver on time without compromising on quality.
- Ability to communicate effectively verbally and in writing, good negotiation and influencing skills.
- Acts Decisively. Makes decisions in a timely manner, makes good decisions based upon a mixture of analysis, experience, and judgment.
- Able to demonstrate good planning and organisation.
- Dealing with Ambiguity. Can effectively cope with change and handle risk and uncertainty.
- Emotional Intelligence. Identify, assess and control the emotions of oneself and awareness of others.
- Takes Responsibility. Takes personal ownership of responsibilities and outcomes while following through on commitments
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.
Quality Assurance and Control
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Top Skills
Eqms
Gdp
Gmp
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Quality Management System
Trackwise®
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