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QMS Champion

GSK

Posted on December 2, 2019

3 - 10 years Jeddah - Saudi Arabia

Any Graduation. Any Nationality

Opening 01

Job Description

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Key Responsibilities
• Act as the QMS Champion across all Site operations. Act as a point of contact and provide support / training / coaching for QMS Process Owners and QMS Reviewers
• Manage local QMS implementation process, and to ensure the effective implementation of the QMS at site.
• To undergo training in GQPs and PGSOPs on Effective QMS Implementation.
• To notify operational managers, technical experts and other impacted target groups of new or revised QMS documents.
• To identify resource capable of performing gap analyses between site/LOC or global function SOPs, standards, facilities or systems and the QMS updates.
• To ensure training needs are assessed for target groups and training plans prepared in advance of receipt of new or revised QMS documents.
• To act as the principle point of contact between the Central QMS Team and site leadership teams for effective communication of existing, new or revised QMS requirements.
• To ensure gap analyses are conducted, and risks associated with gaps are assessed and action plans to address risks are established in accordance with QMS
• To escalate significant QMS risks and issues related to QMS implementation.
• To provide regular reports on progress against gap closure action plan and ongoing QMS in place and in use performance, for local Quality Council review.
• To ensure a robust mechanism for sustaining conformance of the local quality system with QMS requirements has been established and remains effective.
• To ensure local audit processes build in routine assessments of QMS in place and in use status.
• To share and publicize achievements and QMS implementation successes, recognizing and In conjunction with the Senior Quality Executive ensure that the process is in place and in use
• Adhere to Safety, Quality and GPS standards and sustain the relevant QA & EHS KPI metrics to achieve Zero Accident, Zero Defect, Zero Waste and continues improvements.
• To support the deployment and adherence of Data Integrity Program at site and integration of Audit System / QMS with RMS system.
• Review, communicate, update and maintain the assigned Technical Terms of Supply.
• Perform Periodic Product Review on annual basis as per approved schedule. Track adherence to schedule for timely completion without any overdue PPR.
• Keep all tracks & record of SFDA guideline gap analysis.
• Participates in the regulatory compliance process to provide data on time to PE GMS Compliance Review Committee.
• Responsible for maintaining Site QWF Workflow & keeps tracking of all actions for their timely closure & escalate any expected delay of closing to Compliance Manager.
• Participate in LIC & PIRC processes as & when required to support QA Compliance Manager.
• Responsible to prepare & review Standard Operating Procedure relevant to QA Compliance function.
• Responsible for site record retention activities performed on annual basis in QA-Compliance department.
• Execute & coordinate with site departments for lighten-up project in Record Retention & outcome reported to Compliance Manager. Maintain the critical & highly confidential documents in the Document Archive Room under safe custody without any damage or deterioration with easy traceability.
• Review archived quality critical documents on routine basis to carry in their destruction process which has passed their retention period. This process mainly performed on quarterly basis & keeps the record of destruction for reporting in lighten-up process.
• Involve in internal (L2), A&A, CAG and Regulatory audits to support Compliance Manager.
• Identify departmental quality risks and escalate to the Compliance Manager.
• Involve in QMS gap analysis as a reviewer to identify gaps pertaining to Compliance function.
• On time complete training curricula assigned in My-Learning or QMS training and provide the training to the staff where it is required.
• Promote safe-working environment that complies with company EHS requirements.
• Following and sustaining GPS standards in QA Compliance Department. Adhere to quality KPIs within the department.
• Adhere to Safety, Quality and GPS standards and sustain the relevant QA & EHS KPI metrics to achieve Zero Accident, Zero Defect and Zero Waste for continues im
job requirements
More than 3 years


Corporate Planning / Consulting / Strategy / M&A

Desired Candidate Profile

Educational Background
1. Minimum Level of Education
Bachelor degree
Area of Specialisation
Science or Technical discipline
Why is this Level of Education Required?
To have an ability to understand the pharmaceutical business and to be able to manage the people and to ensure the people capabilities are Build on right approach and standards
2. Preferred Level of Education
Master degree or equivalent in pharmaceutical sciences
Area of Specialisation
Science or Technical discipline
Why is this Level of Education Preferred?
To have an ability to understand the pharmaceutical business and to be able to manage the people and to ensure the people capabilities are Build on right approach and standards
B. Job-Related Experience
• A degree/professional qualification in a relevant discipline (preferably Pharmacy) with at least 8-10 years experience working in a Pharmaceutical-manufacturing environment.
• Strong knowledge of the QMS compliance, specifically the Global Quality Policies and Guidelines and manufacturing operations.
• Excellent communication skills and the ability to build relationships at all levels and across functions.
• High level of relationship building/influencing skills Sound knowledge of standard desktop applications
Why is this Level of Experience Required?
• To understanding the Quality and GMP applicable within the pharmaceutical industry, including change control, registration and regulatory procedures. Strong understanding of QMS and its application on the Site.
• Role requires and interpretation of regulatory and pharmacopoeia standards and Regulatory Agency requirements.
C. Other Job-Related Skills/Background/Quality related requirements
Business challenges
• The role will need to monitor the changing global regulatory environment to ensure QMS is deployed in timely manner.
• Influencing the Site Leadership Team and line managers at site to effectively prioritise and support the delivery of required QMS activities.
• To positively influence a quality culture and appropriate ways of working across the site to ensure QMS is effectively implemented and in-use . Role requires a strong working relationship with the Core QMS team. Liaison with Site Quality Head in the organization of QMS reviews and liaison with QMS Process Owners and QMS Reviewers across site. Ability to support inspections for the measurement of the effectiveness of QMS in-use .
• Ability to work effectively in a matrix environment at site.
Personal challenges:
• Establishing strong working relationships with a broad range of individuals at both a site and central level, including senior stakeholders, line managers and above site group.
• Ability to demonstrate a flexible and pro-active approach to an area of significant change currently that will impact ways of working at site

Keywords

QMS Champion

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