The key role of Upjohn SCQ is to establish and maintain an appropriate and sustainable Product Quality System and Quality Culture within Upjohn and any contractor related to GMP/GDP activities, so that compliance with Upjohn and Regulatory authority expectations and protection of Upjohn patients/customers from any product quality risk are ensured. SCQ is the main point of contact for the investigation and resolution of all product quality issues discovered or originating in the PCO and for interacting with the relevant local stakeholders, UGS and local regulatory authorities on such issues. Coordinates and monitors the product quality and compliance activities at the PCO to ensure that current regulatory expectations are met and facilitates internal and regulatory GMP inspections. Acts as a qualified person responsible to local authorities and oversees Qualified person’s activities for all Upjohn quality compliance issues, if needed.
Role Description And Main Responsibilities
Maintenance of the compliance to the local BOH regulations
- Coordinate the product quality and compliance activities at the PCOs, to ensure current BOH expectations are met.
- Act as the Qualified / responsible Person to local authorities or support Qualified Person activities for all Upjohn Product Quality Compliance issues in the market.
Governance & internal organization
- Responsible for the timely implementation of all applicable GSOPs within the PCO.
- Ensure SCQs and all relevant PCO colleagues are appropriately trained in the Product Quality SOPs.
- Quality management review : Monitor KPIs, analyze collected metrics, evaluate and highlight any significant trends and identify actions. Ensure metrics are tracked in the global system.
- Conduct quality management and metrics review with relevant stakeholders.
- Conduct/Oversee completion of internal assessments to ensure compliance with product quality systems and processes and to identify improvement opportunities.
- Assess new or proposed quality system/local regulatory requirements and adjust/enhance local systems and processes when required.
- Support the implementation of all elements of SCQ Training systems in PCO, including implementation and refresher training on GDP/GMP to applicable PCO colleagues.
- Ensure that all assigned Upjohn trainings ( P2L for example ) are completed in timely manner
- Participate in regular meetings with relevant PCO stakeholders
- Manage commitments resulting from deviation management, change control, local regulatory authorities’ inspections and internal audits.
- Manage planned, permanent and temporary changes of GMP/ GDP related activities and systems in the PCO.
- Participate and or organize change’s committee as appropriate and ensure the required approvals.
- Ensure change actions completion as per the agreed timelines.
Inspection and Internal Audit
- Lead preparation and coordination of GMP/GCP/GDP/MAH related inspections of PCO Upjohn internal/MSQA audits
- Work with SCQ RL and local functions to Prepare an appropriate action plan to address the inspection/audit observation.
- Responsible for implementing and tracking the commitments/identified actions within agreed timelines.
- Internal self-inspection process management:
- Setting the SI plan according to local needs and priorities
- Ensure the timely implementation of the self-inspection plan as per the assigned tasks as auditee and / or auditor.
3. Product quality assurance & operations
Notification to Management
- Notifies SCQ Regional Lead of significant product quality and compliance issues.
- Attend AQRT meetings, as PCO representative, to provide the local perspective on the issue at hand.
- Provide AQRT Executive Summary including local investigation results and proposed CAPAs for issues originating under the responsibility of the PCO.
- Ensure the local implementation of actions identified during AQRT meetings e.g. recalls, communication with Regulatory Agency, local CAPAs and provides feedback on progress
Deviation and CAPA Management
- Perform investigation of product quality incidents that occur within the responsibility of Upjohn country office in cooperation with the relevant internal/external functions.
- Track the preventive and corrective actions until completion within the set due dates.
Product Complaint Handling (if applicable for Country) Scenario 1: manager is handling product quality complaints
- Manage the intake and triage of complaints from the markets under PCO responsibility, assign class and criticality to the product complaint and forwards them to the appropriate investigating UGS/Contractor manufacturing site via the global complaints management system (QTS-CITI)
- Develops and issues responses to complainants in a timely manner.
Local Product Disposition
- Responsible to Review all documents and records relevant to the imported products and perform the necessary activities to provide a disposition decision to the products to the market sale in compliance with local regulatory requirements and Upjohn procedures.
Quality Oversight of local repackaging/relabeling operations
- Ensure relabeling/repackaging contractors have been assessed and approved
- Ensure local regulatory authorities approval of the repackaging/relabeling activities
- Ensure all needed Upjohn approvals are completed and escalate packaging requests for regional lead approval
- Ensure SCQs release of the repackaged/relabeled product according to the GSP/PQS and local requirements
- Notify Regional Lead of deviations or concerns occurred/noted during repackaging/relabeling operations and any issues with the potential to impact marketed product
- Responsible to define requirements under which returns can be taken back to saleable stock and supports local actions in cooperation with Logistics and Distribution Centers.
- Assess the returned goods and provide a disposition decision if applicable
Quarantine Alert Notices
- Receive and manage Quarantine Alert Notices (QAN) issued by Upjohn manufacturing site, Contractor manufacturing site or distribution center.
- Ensure status of impacted batches at logistics center/LSP/contract vendor is changed to Blocked/Hold and then aligned with final disposition decided by QAN issuing site
- Provide the required responses to QAN issuing site on timely manner.
- Attends, as needed ( as backup for example ) , Area Quality Review Teams (AQRT) meetings, as principal PCO representative, to provide the local perspective on the issue at hand.
- Supports to provide the local perspective on the issue and draft AQRT Executive Summary for issues originating under the responsibility of the PCO.
- Implements the local actions identified during Area Quality Review Team (AQRT) meetings, e.g. recalls, communication with Regulatory Agency, local corrective/preventive actions.
LSP / Contractor management & oversight
- Oversee quality operations at contractors or provide feedback to the appropriate functions
- coordinate, support and participate in MSQA audits
- Agree with contractors/LSPs on action plans to address observations noted during the audits or regular visits
- Document and track all CAPA plans.
- Notify SCQ Regional Lead of significant concerns or repeated deviations occurred with contractors and all issues potentially affecting marketed product.
- Develop, negotiate and maintain up to date quality agreements with all affiliate GMP/GDP contractors involved in manufacturing, repackaging, laboratory testing or activities at LSPs
Market Business & global Support
- Actively participate in market forum as spokesperson on quality topics.
- Foster and grow departmental communications and networking to assist with the quality reviews and crises management.
- Participates in business initiatives giving advice and assessing the impact to product quality and compliance.
- Ensure effective communication and collaboration with Upjohn (PCO/affiliate) internal stakeholders to ensure alignment and optimal support, launches and continuous availability of quality compliant Upjohn products.
- Ensure effective communication to Upjohn sites and global/regional quality functions about local GMP and other regulatory requirements to ensure appropriate support and documentation for Upjohn products quality compliance release and maintenance in (PCO/affiliate)
- Work closely with other platform lines to achieve process development and improvements as ONE Upjohn.
- Actively promote the SCQ team
Responsible Pharmacist Responsibilities
- Registered at Egyptian Health Authority as the responsible pharmacist for Upjohn scientific office.
- Responsible to ensure compliance with country regulation.
- Responsible to ensure alignment and implementation of ant updates within the country health authority regulations.
Years of experience 5-8 years in the Pharmaceutical or related regulated industry.
- The applied candidate should be pharmacist.
- Has comprehensive knowledge of the quality principles, concepts of quality and comprehensive technical experience.
- Has strong technical experience with quality systems (change control, deviations, complaint management, documentation management, audits, inspections, etc.).
- Able to work and contribute effectively in cross-functional team, culture differences, diversity.
- Able to make sound and effective quality decisions independently in complex and ambiguous situations.
- Advanced judgement and analytical skills.
- Show strong negotiations and effective communication skills with internal and external business partners.
- Strong technical writing and presentation skills.
- Strong planning & organizing skills.
- Fluent in English language
- Budget management knowledge.
Soft skills/ management & leadership skills
- Self-motivated, confident with working independently, motivate others, Business acumen.
- Act decisively and take strategic decisions.
- Grow self.
- Hold People accountable.
- Change agile.
- High self-awareness.
- Influence others.
- Emotional intelligence skills and Knowledge.
- Take appropriate risk to advance new concepts and methodologies that address technical and organizational improvement and encourages others to do the same.
- Provides guidance to team members and lead complex projects and situations.
- Evaluating and continuously improving affiliate quality systems to advance quality culture.
- Apply skills and discipline knowledge to contribute to the achievement of work within department.
- Contribute to the completion of routine work team related tasks.
- Build trust and credibility with internal and external business partners and regulatory authorities.
- Develops leadership skills.
- Efficiently represent quality compliance department.
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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