Job Purpose :
Manage and ensure Implementation of required Quality parameters of GSK Quality Management System and Implementationof CH QS SOP, QualityPoliciesatalllevelsofmanufacturing,storageanddistributiontoachieveQuality compliance
Key Responsibilities :
Ensure that the Site has implemented robust Quality Management Systems in compliance with GSK Quality Policies and all relevant regulatory and legislative requirements.
Ensure the implementation and management of the Site Document Management System in accordance with GMP documents and record management policy.
Ensure local Quality Systems are established that comply with company Standards, local regulations and country regulations for those countries where the product is marketed.
Manage and ensure Implementation of required Quality parameters of GSK Quality policies and Implementation of Quality policies at all level of manufacturing, storage and distribution.
Ensure to provide the progress on QMS in-place and in-use performance for Quality Council Meeting
To act as the principle, point of contact between the Global CHQS team and Site / Function Leadership Teams for effective communication of existing, new or revised CHQS SOPs / QMS requirements.
Coordinate and monitor all the activities of QMS Documents assessment and implementation received from CH Global team.
Distribution of QMS Documents received from QS Network to concerned department for timely gap assessment so that QMS Documents can be authorize for use at site within global due date.
Assure timely completion of all corrective actions defined in the gap assessment so that QMS Documents can be implemented at site with in global due date.
Assure timely posting of Assessments and Implementation of QMS Documents at QMS SharePoint
Review all local SOPs to ensure that SOP is in accordance with the respective QMS Policies.
Co-ordinate the creation and governance of site annual Quality Improvement Plan.
Monitor and report the overall effectiveness of QMS implementation
Coordinate across site to finalize scoring of Quality Risk Model at Site
Oversight all Validation activities at site including process validation, cleaning validation and equipment qualification according to Site Validation Master Plan
Ensure that the Site has a Comprehensive "Site Validation Master Plan" and it is properly executed according to approved schedule of activities.
Comply and ensure compliance to GMP (Good Manufacturing Practices), Quality and other related policies, guidelines and requirements as applicable by law and GSK Corporate Guidelines.
Comply and ensure compliance to Environment, Health and Safety policies, guidelines and requirements as applicable by law and GSK Corporate Guidelines.
Any other responsibility assigned from time to time as per business requirements.
Basic Qualifications :
We are looking for professionals with these required skills to achieve our goals :
MSc. in Chemistry or Pharm - D
Preferred Qualifications :
If you have the following characteristics, it would be a plus :
Manage projects and continuous improvements within the team
Excellent interpersonal, consultative, listening, communication, and analytical skills
Ability to work well under pressure with tight timelines
Knowledge and application of the principle of the Quality Management System
Required Experience :
4-6 years of relevant experience
Our values and expectations are at the heart of everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork.
As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities :
Operating at pace and agile decision-making using evidence and applying judgement to balance pace, rigour and risk.
Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
Continuously looking for opportunities to learn, build skills and share learning.
Sustaining energy and well-being.
Building strong relationships and collaboration, honest and open conversations.
Budgeting and cost-consciousness.
Contact information :
You may apply for this position online by selecting the Apply now button.
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