- Job Title Supply Chain Quality (SCQ Officer/ Specialist )
The key role of The company SCQ is to establish and maintain an appropriate and sustainable Product Quality System and Quality Culture within the company and any contractor related to GMP/GDP activities, so that compliance with The company and Regulatory authority expectations and protection of The company 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 stakeholders 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 GDP inspections.
Role description and Main responsibilities
1. 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.
2. Governance & internal organization
• Supports timely implementation of all applicable Product Quality SOPs (issued by SCQ) within the PCO.
• Ensures that all relevant PCO colleagues are appropriately trained in the Product Quality SOPs.
• Assess new quality system and local regulatory requirements to enhances and align local systems and processes when required.
• Conducts and documents periodic assessments to determine if a revision, retirement, administrative change or no change is required for the Product Quality SOPs (issued by SCQ) within the PCO.
• Collects data and reports quality metrics of PCO and contractors to allow quality performance assessment.
• Together with the SCQ Manager/ Sr Manager, assess quality performance to identify trends and improvement opportunities.
• Participates in the PCO/Contractors quality management reviews and follows-up for the recommended actions, when required.
• Support the implementation of all elements of SCQ Training systems in PCO, including implementation and annual training on GDP/GMP to applicable PCO colleagues.
• Ensure that all assigned company trainings (P2L for example) are completed in timely manner
• Uses and maintains tracking tools to track any GxP commitments raised by SCQ or under SCQ oversight.
• For any commitment opened, ensure that due dates are based on risk, complexity and urgency, and that the timeframes given are realistic, to meet the stated requirements.
• Handles any planned, permanent and temporary changes of GMP/ GDP related activities and systems in the PCO.
• Participates in the changes committee as appropriate and ensures the required approvals.
• Ensures change actions completion as per the agreed timelines.
Inspection and Internal Audit
• Participate in preparation and coordination of external and company internal inspections and audits.
• supports the development of CAPA plans and follow-up to the timely closure in coordination with other relevant functions.
• Internal self-inspection process management :
Support / 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
• Informs SCQ manager of any significant deviations and complaints, that could lead into a NTM.
• Ensure notification is done within the appropriate timeline and process.
• Perform, if needed, investigation of product quality incidents that occur within the responsibility of company 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
• Manage the intake and triage of complaints from the markets under PCO responsibility, classify the product complaint, and forwards them to the appropriate investigating PGS/Contractor manufacturing site via the global complaints management system (QTS-CITI).
• Develops and issues responses to complainants in a timely manner
• Tracks complaint responses.
• Notifies the Management when needed.
Local Product Release & Temperature excursion
• 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 company procedures.
• Communicate the disposition decision with internal and external stakeholders.
• Document any temperature excursion and coordinate with manufacturing site for assessment and via the global Quality Tracking System (QTS).
Local Repackaging/Relabeling operations
• Ensures that contractors have been assessed and approved before performing any relabeling/repackaging activity.
• Depending on the local model/ structure, if needed, obtains Regulatory approval of the repackaging/relabeling activity.
• Completes the required documentation and obtains the necessary approvals from company Regulatory functions and manufacturing sites.
• Oversees the process of repackaging/relabeling and reviews operation related documents.
• Releases the repackaged/relabeled products according to the local decision matrix or according to the Manager/ Sr Manager instructions.
• Assess the returned goods and provide a disposition decision
Quarantine Alert Notices (special situation)
• Receives and manages Quarantine Alert Notices (QAN) issued by the company manufacturing site, Contractor manufacturing site or distribution center.
• Ensure status of impacted batches at logistics center/LSP/contract vendor is changed to Blocked/Hold
• Provide the required responses to QAN issuing site on timely manner.
• Ensure status of impacted batches is aligned with the final disposition decided by QAN issuing site.
Market Action (special situation)
• Attend, as needed, Area Quality Review Teams (AQRT) meetings, as PCO representative, to provide the local perspective on the issue at hand.
• Support SCQ manager to provide the local perspective on the issue and draft AQRT Executive Summary for issues originating under the responsibility of the PCO.
• Support the local implementation of actions identified during Area Quality Review Team (AQRT) meetings, e.g. recalls, communication with Regulatory Agency, local corrective/preventive actions
4. LSP / contractor management & oversight
• Participates as needed in contactors visits/ audits.
• Reviews, negotiates and tracks, according to the Manager/ Sr Manager instructions and maintain up to date Quality Agreements of GMP/GDP contractors.
• Review, negotiate and maintain up to date Quality Agreements of GMP/GDP contractors according to the Manager/ Sr Manager instructions.
5. Product Quality Reviews
• Perform PQR’s timeously as per the approved schedule.
Years of experience: 2-5 years in the Pharmaceutical or related regulated industry
• Has an appropriate education in science or quality topics; Bachelor’s degree, pharmacist. Masters degree is an advantage
• Has basic knowledge of the Quality principles, concepts of Quality and basic technical skills
• Has basic knowledge about Quality Systems (Change Control, deviations, complaint management, documentation management, audits, inspections, etc.)
• Able to Participate effectively in cross-functional team
• Analytical skills
• Basic level in English
Soft skills/ Management & Leadership Skills
• Self-motivated, Business acumen
• Act Assertively
• Grows Self
• Change Agile
• Planning & Organizing skills
• Able to Make decisions within guidelines and policies
• To use new ideas and knowledge with increasing frequency, Begins to explore and apply ingenuity to experimentation .
• Able to work in ambiguous situations as part of a Work Team
• Applies technical skills to achieve assigned tasks
• Has effective communication, writing and negotiation skills
• Able to align with global strategies
• Efficiently represents Quality Compliance positions
Send your CV to Vicki at email@example.com
Should you not receive any correspondence within two weeks of submitting your application, please consider your application unsuccessful.