Job Description
Job PurposeTo implement cGMP practices and quality standards on processes, products, personnel, and systems and ensuring compliance to internal control procedures and regulations. Providing technical and document management support participating in investigations processes, implementation of corrective and preventive actions ensuring adherence to corporate and regulatory standards.Education, Experience & SkillsPharm D, Masters in science, Bachelors in science 3-5 Years of experience in a similar role.Good communication and presentation skills, Analytical skills, Proactive approach.Key ResponsibilitiesTo perform in process checks during filling and packing operations during morning and night shift according to SOP’s and standard pack specifications and collect samples accordingly to comply with GSK specifications, and to ensure the test results are complying with the GSK specification and must check the analytical raw data and calculation sheets. Also check Analyst signature on raw data, chromatogram, and calculations, also ensure that all finished product is released according to GSK specifications, also Have sufficient knowledge of dMERP and support in Batch release activity.To prepare SQC minutes, tracking of actions and compilation SQC data received from entire quality department.To revise and update IQA and QA whenever required.Adhere to EHS and Quality standards and guidelines.Ensure departmental SOPs are in-line with QMS and Safety requirements and their in- place and in-use, and Support in conducting management monitoring inspections, also ensure timely completion of all actions and CAPAs assigned with respect to deviations, change, risks, complaints, audits etc.To review and approve SAP related queries and act as SME for Quality related transactions.Act as Administrator of VQD, VQMS, sail point and LIMS and responsible for governance.To manage the process of PPR at site in a well-defined procedure and controlled manner.To ensure trainings are completed on time in myLearning or as required by training department.As Site DI lead along with relevant SLT member to prepare CAPA plan / budget allocation and Site System DI Assessments needs to be completed as per site plan and as per the outcome.As Site DI lead Coordinate DI awareness activities, facilitate DI compliance and review other Sites DI related risks, audit findings and sharing with Site staff for proactive actions, also Share DI Alert and learning points with Site make sure action taken if needed.As Site DI lead make sure DI plan is in place and embedded in Site audit program / Risk Assessment/ Communication Plan and make sure Site Staff DI training programmed.As Site DI lead make sure DI score is being assessed and entered to QRM on time and actions are tracked and Coordinate Functional DI representatives at Site to pull together DI related issues.To ensure that Quality improvement Plan is in place and responsible for its governance.Ensure that customer complaint is record on VQMS, Log the complaint and co-ordinate investigations and Complaint Report Approver, Monthly reporting, management review, trending, recording and retention of investigation and complaint samples.Participating in Level I, Level II, Level III and Level IV audit of site and maintain their trackers for compliance purpose and to ensure improvement of Quality processes at site.As a Change Control Lead who ensures full deployment of GSK’s Quality management system for Change control, ensuring requirements are both in place and in use, including development of appropriate KPI’s and monitoring of these through governance process, Coordinates the evaluation of all changes with potential impact on product Quality, GMP or regulatory Compliance at site level. Reviews and approve change control Requests/Assessment from the Quality standpoint, as a designate of Operational Quality manager and also ensure that the Change control evaluation is appropriate to achieve the desired result and does not include the Quality risks or potential issues elsewhere (Including within site or Supply chain).As a Change Control Lead act as process owner of Change management process at site and responsible to manage all GxP and non GxP changes as per defined procedure and also responsible for conducting panel meetings and coordinates with stakeholders for smooth execution of respective change and also responsible for overall change process governance and responsible for all activities assigned as per Change Control procedure.As a Deviation lead assess the unexpected condition, classify the deviation, describe the level of investigation required and support investigation with relevant team for identification of root cause & CAPA and to ensure that all investigations are completed within timeframe. Periodic review of deviations for adverse trend and CAPA effectiveness.As a Deviation lead address quality and compliance issues and continuously improve operations by identifying, recording, and implementing Corrective and Preventive Actions (CAPA). Define the CAPA Plan and track CAPA actions to ensure the compliance and to avoid any overdue.As a Deviation lead determine the CAPA Effectiveness Requirements and verify the CAPAs for its effectiveness. Approve the final CAPA closure by checking the evidence provided to prove the CAPA is in place and confirming that the requirements for any independent CAPA effectiveness checks are complete. Track and review open deviations in the daily tiered accountability meetings. Determine if the deviation meets any criteria for escalation to a Local Incident Committee (LIC) or Product Incident Review Committee (PIRC). If so, escalate.Any other responsibility assigned by manager from time to time as per business requirements.Why GSK? Uniting science, technology and talent to get ahead of disease together. 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. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).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 place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.Contact information:You may apply for this position online by selecting the Apply now button.Important notice to Employment businesses/ AgenciesGSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
