Employment Nigeria 01-Jan-1970 NIGERIA , NIGERIA ,
CURRENT JOB VACANCY AT GLAXOSMITHKLINE GSK
JOB LOCATION: QUALITY ASSURANCE MANAGER
JOB LOCATION: LAGOS
JOB PURPOSE
RESPONSIBILITIES
1a. Implement and maintain effective Quality Assurance systems to ensure that local technical operations are in full compliance with GSK standards and policies, Guide for Commercial Companies ,GMP/ GDP and regulatory requirements.
b. Develop, specify and approve systems that have an impact on the quality of imported, products in line with all relevant GQPs.
c. Monitor and assess quality systems by means of audit and self-inspection, and other forms of evaluation against GSK standards, GQPs, GMP and regulatory requirements.
d. Ensuring a quality assurance input into the main aspects of the local company operations that influence product quality.
e. Manage the preparation and conduct of audits for the LOC
2. Ensure timely local Quality release of imported finished goods deliveries and resolve Quality-related issues arising from these deliveries.
3. Acts as the primary liaison with 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
4. Ensure that all colleagues in the commercial operating units are adequately trained on the procedures and processes that relate to QMS implementation and regulatory compliance
5. Ensure the QMS implementation is lean as well as compliant and activities conducted to ensure sustainability adopt the principles of OE.
Product Incidents/ Customer Complaints
1. Manage product incidents and support product recalls.
2. Report and follow-up on product complaints with manufacturing sites, customers and Commercial teams.
3. Conduct analysis of product complaint trends in conjunction with Medical Affairs
4. Attend the weekly QA Escalation Phone Calls, or ensure a nominated Colleague attends
Artwork management
1. Oversee the effective implementation of Artwork Management procedures within the commercial teams
2. Manage labeling text and packaging components to ensure compliance with local registered details and corporate prescribing information.
3. Plan and co-ordinate pack changes, online artwork creation and proof-reading.
4. Ensure that the commercial business units can effectively use the global pack management systems (GPM) for Artwork Management by acting as business deployment lead to relay GPM requirements and also to feedback the market needs to GPM
Change Control
1. Management of the Change Control System.
o Review, Comment and approval of Cx change controls and deviations
o Quality input into Cx Commercial New Introduction projects
o Quality input into Cx Commercial change projects
2. Training and support of the wider consumer healthcare team in the change control system
Local Repacking:
1. Manage all matters pertaining to regulatory and QA compliance for repacking procedures to ensure timely QA batch release of repacked orders before distribution and/or re-export:
Liaise with distributor on repacking instructions, and monitor repacking processes.
Liaise with printer on the component artworks.
Proof check and QA release incoming stocks and components before repacking.
Ensure documentation of batch records and retention of samples.
Distributor/ Logistics Service Provider/ Contractor Management:
1. Conduct audits of local Logistics Services Provider, Distribution warehouses, repackers and printers/ artwork studios and ensures that the contractors comply with GSK and regulatory requirements.
2. Approves the use of local Distribution warehouses, repackers and printers/ artwork studios
3. Review, update and finalize all Distributor, repackers and printers/ artwork studios Quality Agreements at renewals
4. Extending to end to end supply chain Quality Management
Regional Quality Activities:
1. Support local stakeholder management as required
2. Develop a network to obtain regulatory intelligence and provide the necessary analysis to understand and escalate issues which have the potential to impact supply or GSK’s reputation.
3. Work in the model of GSK Governance and Advocacy to ensure effective collaboration and the ability to draw on their expertise when required to collect and collate intelligence.
4. Provides visibility via an agreed framework to Regional QA of the priorities of both Sites and LOC Regulatory with the aim of agreeing the correct priorities for GSK.
5. Act as a quality contact for Regional Quality Consumer Healthcare and LOCs in the region in relation to quality ,compliance issues and as appropriate reporting KPI’s/ progress on QMS implementation/sustainability and Quality Plans
QUALIFICATION AND EXPERIENCE
• Successful completion of relevant tertiary qualifications – science degree
• Minimum of 5-8 years experience within the Pharmaceutical / Consumer Healthcare industries, preferably in the capacity of a senior quality specialist or a manager
• Strong understanding of and experience in quality assurance systems particularly in the areas of batch release, product incidents, artwork control and performing audits
• Strong knowledge of regulatory requirements pertaining to GM
How to Apply
CLICK HERE TO APPLY
Closing Date: 10 / 10 / 2012
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