Quality Executive for a leading Pharmaceutical company

Job Purpose
Quality Executive
Provides effective and efficient quality assurance systems support to the Quality Lead, including supporting the implementation and maintenance of the QMS and as directed by the Quality Lead, performs the day to day work to ensure that the quality systems required by the element of the Supply Chain and Marketing Company are performed in a lean and efficient way and meet the compliance standards of the QMS and the local Regulator(s).
Key Responsibilities
Describe the key deliverables, specific duties, any specialist duties and the ongoing responsibilities of the role.
Quality Strategy

• Maintain a high level of QMS knowledge and awareness of changes within the commercial environment to seek opportunities and manage potential business adversity.
• Act as the relevant quality contact for the Regional Quality organization providing communication to the regional quality organization on progress on QMS compliance status updates on quality plans and escalation of issues. Share learning\'s and issues appropriately with other regional colleagues.
• Gain an understanding of the Supply Chain and Commercial Business and Quality Plans at a high as they potentially link to day to day and quality improvement activities.

Quality Systems

• Supporting the Quality Lead to ensure a robust, sustainable and effective QMS (Quality Management System) through monitoring and reviewing the compliance status within the element of the Supply Chain and Gulf Marketing Company.
• Support the implementation and maintenance of effective Quality Assurance systems to ensure that local operations are in full compliance with company standards and policies, Guide for Commercial Companies ,GMP, GDP and regulatory requirements by supporting the Quality Lead as directed to:

• Ensure that all SOPs are in place, updated & training has been conducted across the business. Ensure a monitoring system in place for tracking training compliance and process for escalation of persistent non-compliance. Processes in place for delivering routine training for updates to SOPs, GQPs, and GQMPs as relevant.
• Promote QMS management principles and seek continuous improvement of the processes
• Review, conduct impact assessments and implement any updates to QMS policies
• Manage QMS Management Review meetings according to local SOPs
• Identify, Implement and Manage QA Objectives & KPIs
• Establish and manage Annual Quality Plans

• Support the Quality Lead to ensure that all internal procedures and systems in use in the are compliant to QMS, Guide for Commercial Companies and local regulatory requirements, including (but not limited to)

• Quality Council - support the Quality Lead re organizing Council meeting with regular meetings. This support should ensure that the Quality Council format, frequency and reporting are standardised to global requirements. In addition support should be provided re Quality metrics and reporting format/ system in place.

• Change Control - perform day to day work to support the local change control process with the aim of ensuring all planned major changes (including as appropriate new pack introduction, product discontinuation, major pack changes, re-packing activities) are effectively and compliantly managed. Processes in place to routinely review progress of changes and close out when completed.

• Risk Management - perform activities to support the risk management process to ensure effective management, timely reporting, review and escalation of quality risks.

• Corrective and Preventative Actions (CAPA) - Implement global or local process to effectively manage corrective and preventative action plans. Develop local processes to conduct root cause analysis to investigate deviations and develop CAPA\'s. Local process in place to track and review CAPA plans on routine basis. Demonstrate that Gulf effectively identifies where CAPA plans required and that they are effectively implemented, monitored and closed out.

• Auditing - perform day to day work to support the local process that is in place for MM and IBM auditing. Work with the Quality Lead to ensure:

• The MM and IBM auditing process includes clear accountability for sign off of audit reports and resultant CAPA/ Risk management.
• MM and IBM audit universe is defined and agreed with Regional Quality and annual audit schedules in place.
• There is a process in place to ensure all new and existing suppliers/ 3rd party contractors/ service providers that have a direct impact on product quality are identified and audited by QA Team or the appropriate Central Team (e.g. ESA). e.g. distribution sites, repacking contractors, warehouses, freight management, samples supply, off-site archive sites, artwork printers, printed packaging component suppliers.
• Availability if requested to participate in MM and IBM audits with the agreement of the relevant Central Team
• The commercial element of the Supply Chain and the Quality elements of the Marketing Company are audit ready.

• Complaints - perform day to day work to support an effective complaints management process ensuring

• the assessment of potential issues are determine as quickly as possible and linked to the adverse event reporting process and local product incident process if/as appropriate.
• report and follow up on product complaints with manufacturing sites, customers and commercial teams.

• Incident management - Support the Quality Lead to ensure that an effective local product incident process is in place to escalate and manage any product quality related issues and in the training of all relevant staff in local incident management process and global PIRC process. Assist the Quality Lead in any investigations triggered by local incidents and in conducting Local Incident Committees (LICs).

• Product supply - performs day to day work to support systems that have an impact on the quality of imported, products in line with the QMS and local Regulatory requirements

• responsible for the review and at the direction of the Quality Lead the approval of TTS (Technical Terms of Supply)/IQA (Internal Quality Agreement) and liaison with manufacturing sites to ensure compliance to local registered technical details.
• Liaison with External Supply Quality for products that are manufactured by contractors to ensure compliance to local registered technical details.
• Ensure timely local Quality release of imported finished goods deliveries and resolve Quality-related issues arising from these deliveries.
• Support the Quality Lead with communication to the GMS supplying sites, R&D and Regional Quality as it relates to approval of repacking activities and resolving Quality issues with the product supplied

• Artwork management - perform oversight of Artwork Control Procedure

• Local Repacking - perform day to day work to support repacking requests ensuring regulatory and QA compliance, timely QA batch release of repacked orders before distribution and/or re-export. Ensure as appropriate documentation of batch records and retention of samples.

• Third Party Oversight (MMW, 3PL and Distributor)

• To perform MMW oversight and ensure key process are in place at MMW. Having regular meeting to discuss Quality KPIs and Quality CAPAs
• To ensure Quality KPIs from Distributors are frequently monitored.

• Others

• Acts in the role of the Quality Systems Manager in the absence of the Quality Lead.
• Maintains all quality documentation such as product specifications and Standard Operating Procedures in accordance with company policies.
• Ensures all product specifications and related documents (e.g. CoAs, TTS) are maintained compliant to current registered details.
• Maintains and updates the QA Standard Operating Procedures

Adecco