May 24, 2021
|Career Level||Mid Level|
|Base Salary||Competitive Salary|
Site Name: Pakistan – Sindh – Karachi
Posted Date: May 24 2021
Reporting to the Compliance Lead, this place is liable for managing the connection with assigned third Party Manufacturer to make sure GSK’s product high quality and popularity is protected.
Minimum Level of Education: Degree in a Science or associated self-discipline
Graduation in Chemistry, Pharmacy, Microbiology or one other associated science, enterprise diploma is a plus
Area of Specialisation: Broad and thorough technical, high quality and regulatory information of present pharmaceutical analytical and manufacturing strategies/ processes
Minimum 4-5 years of operational expertise in Manufacturing or Quality Assurance
Knowledge of Quality Assurance Systems and cGMPs
Understanding of working in a extremely regulated atmosphere
In this position,
you make sure that all points of the merchandise at assigned third celebration contractor websites adjust to the necessities of the GSK Quality Manual and meet related cGMP regulatory and legislative necessities, by outlined key efficiency and high quality indicators,
you assess the chance, establish gaps and implement high quality motion plans at assigned CMOs and also you talk to the group so the dangers are proactively addressed
Additionally this position shall be accountable for establishing and sustaining an efficient working relationship with the important thing contacts at every of the assigned CMO(s). These embrace key contacts with (however are usually not restricted to) Quality, Regulatory, Business Development, Production, Site Management and others.
Be the purpose of contact for Quality issues with the assigned third celebration provider.
Ensure that each one points of the GSK merchandise at assigned third celebration contractor websites adjust to the necessities of the GSK Quality Manual and meet all related cGMP regulatory and legislative necessities.
Evaluate effectiveness of the CMO’s Quality Unit and techniques and affect External Suppliers selling strong techniques below self-sufficient organizations. Escalate all severe cGMP/Regulatory compliance points. Monitor the standard efficiency of the External Supplier driving remedial motion the place needed. Monitor and assess exterior suppliers’ key efficiency indicators, akin to complaints and Right First Time as a mechanism to suggest steady enchancment initiatives.
Apply acceptable Risk administration instruments with every CMO/External Supplier in scope, escalating and monitoring important dangers requiring decision, together with grievance monitoring and trending, reporting to Quality Council, Product Incident Review Committee (PIRC) or different company governance processes, as required.
Ensure that investigations related to assigned third celebration websites are correctly carried out, leading to sustainable CAPA, documented, evaluated, and closed as effectively as attainable, and in respect with the process. Support and lead inner audit processes the place required.
Ensure well timed communication of Quality Alert points. Co-ordinate and monitor any remediation deemed needed. Ensure the LOC (Market QA) is knowledgeable as acceptable of any assigned deviations, change controls, audit findings, or complaints which can have influence on product bought of their market.
Drive periodic overview of Quality Systems on the CMO, to enhance audit course of. Conduct root trigger evaluation critiques for identification of points and improvement of remedial actions.
Review and reply to External Supplier regulatory inspections on issues that contain actions associated to GSK merchandise. Assess influence of inspection and External Supplier responses to Regulatory observations previous to submission to the related company.
Work with CMO to determine significant CAPAs, in response to GSK audit observations and handle to acceptable closure. Track and guarantee well timed and acceptable closure of efficient corrective / preventive actions at assigned third celebration websites. Take the lead to make sure that any commitments given to address audit observations (each GSK and Health Authority) by assigned third celebration websites are carried out as described within the agreed timeframe.
Support new product introductions from an operational perspective. Eventually overview and approve important documentation related to the introduction or switch of a brand new or present product to CMOs,.
Ensure that central database like TIMS are saved updated for Quality part
You might apply for this place on-line by choosing the Apply now button.
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