Job Purpose
To 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 & Skills
Pharm D, Masters in science, Bachelors in science
1-3 years prior experience
Good communication and presentation skills.
Analytical skills.
Documentation and report writing
Key Responsibilities
Perform in process checks during production operations according to SOPs and standard pack specifications and collect samples accordingly to comply with GSK specifications and Verification of Line Clearance process as per defined procedure.
Collect the reference, retention, stability, and validation samples of the released products as per plan, when required and Preparation of sampling plan for Keeping samples as required.
To ensure that record retention area is maintained and documents are placed as per retention period and category.
To confirm that all documents required are received on time and after completion, reconciliation of finished products is done as per GSK specifications and ensure data integrity.
Compilation & reviewing of bulk documents and timely updation of the bulk documents status to ensure that Quality products are released and marketed on time.
To ensure the batch dossiers (BMR/ BPR) comply with GSK Policies and regulatory requirement 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, and have sufficient knowledge of dMERP and LIMS and carry out in Batch release activity.
Confirm all the deviations and other issues (complaints etc.) have been correctly documented and the impact on product has been determined before releasing the batch.
To prepare SQC minutes, tracking of actions and compilation SQC data received from entire quality department and other as per agenda.
Preparation of certificates of analysis for export consignments and submitting it to logistics Department, also to maintain batch records in DRIS.
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.
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.
Adhere to EHS and Quality standards and guidelines.
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:
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