Job Purpose
To lead the Site Quality Compliance function which will help ensuring that all the essential activities of Quality Compliance & Validation within the site are undertaken following the appropriate SFDA guidelines, QMS requirements, cGMP standards, and relevant local standard operating procedures.
Your Key Responsibilities
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…
Key Responsibilities
Manages the Quality Compliance departments and systems on site including
Supporting Change Control Process
Periodic Product Review Process
Technical Term & Supply process
Product Recalls including LIC and PIRC
Record Retention
Centralized Document Management System
Supporting in Validation activities
Quality Workflow – Track wise
QMS and Audits
Inspection readiness at Site, escalates any issues which impacting inspection readiness to site senior management
Distribution Risk Assessments (DRA)
Ensures that quality compliance systems on site comply with the requirements of the GSK QMS, GSK internal policies, GSOPs, CAPs and all related regulatory guidelines.
Ensures that system periodic reviews are carried out and that any resultant actions are performed and non-conformances are resolved.
Evaluates change control requests for the impact of change on validation status, review appropriate change management action plans and approves `Change Controls’ for execution as applicable.
To ensure that KPIs are introduced that provide assurance that all the compliance process is effective and drives improvement then monitor and review performance measures.
Ensure departmental quality compliance & EHS risks are identified, reviewed and entered in departmental risk register.
Accountable to develop risk mitigation plan & monitor the implementation plan.
Lead audit, QRI and QMS process at site with all DI requirements.
Build capability of Management Monitoring auditors (self-inspection).
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 improvements.
Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
Bachelor’s degree in pharmacy / Pharmaceutical or related scientific discipline
Minimum 8 years of Experience in Quality Assurance, Compliance, Quality Control, Validation or a related field with minimum 2 years work experience on a position of significant leadership and decision-making role within Quality or a related function.
Preferred Qualifications:
Master’s degree
Essential Skills and Abilities:
Good knowledge of QMS, cGMP and applicable Regulatory requirements.
Good leadership and management skills with a demonstrated ability to function within an independent and team environment.
Strongly developed communication skills both written and verbal.
Strong organizational skills and ability to manage multiple priorities.
Highly results oriented; ability to deliver and overcome obstacles.
Good relationship and people skills along with a strong focus on the customer. Proficient in problem solving. Must be able to conceptualize, initiate and lead projects.
GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.
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