Looking for a opportunities in GSK..! check out the role namely, FLL laboratory in GSK for science or post graduates, Interested and eligible candidates can view all the details given the same below.
Job Role: FLL laboratory
Job Location: Nashik, India
Job description :
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 organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.
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.Job Purpose :
He/She is accountable for the following activities;
SLIMS Deployment and support for SLIMS operations at all sections of QC labrotory .
Support to the production department to meet the manufacturing schedules by timely release of Raw materials/packaging material/ finished products/Bulk testing/Stability testing.
GLP compliance, internal audits, Lab Investigations, Lab Safety, EHS, and Risk management related to Quality department and Values & expectation of the Organization.
Key Responsibilities for FLL laboratory in GSK:
- To ensure adequate QC support to smooth implementation of SLIMS at site.
- Ensure sampling, testing, reporting and release of Raw materials/packaging material/ finished products/Bulk testing/Stability testing.
- All related QC RMS,SOPs, PQS preparation and review to meets all regulatory and QMS requirements
- Carrying out the gap analysis and compliance as per the ATS,CAP, GQP and GQMP
- Control on UK reference standard management require for QC laboratory
- Follow GMP & GLP as per schedule M & L.
- Ensure training of staff in sectional activities.
- Conduct L1/L2 audit as per the schedule.
- To ensure compliance to Safety in QC areas of operation
- Ensure compliance to GPS principles (LSW, Gemba,3Z etc)
Coaching/counseling of staff for adherence to standards related to safety, quality & delivery. . - Coordination & monitoring of dept consumables & inventory.
- Reduction in the cGMP noncompliance coming from L1/L2/L3/L4 audits & WHO audits.
- Handling of electronic systems (e.g. Empower, MERP, VQD, VQMS, SLIMS etc.)
- Handling of incidence, deviation, OOS, and CAPA management.
- Control and maintenance of documents including the quality systems as per the requirement of regulatory authorities which involves all raw data, SOPs, documentation exhibits, Protocols, training.
- To ensure instrumental audit trail program reviewed and documented periodically.
Review of all analytical reports. - To ensure the QC personnel completed the OJT/Analyst Qualification /My Learning modules and QMS training in time.
- Support the functional head to establish the activities assigned or identified “as and when basis”.
Scope of Accountability for FLL laboratory in GSK:
He leverage his expertise for testing and reporting related activity of QC laboratory at Nashik Site.
- People Management.
- People engagement
- Attendance management.
- Weekly Schedule Delivery (CTP).
- Encourage people to raise Gemba Kaizen.
- Effectively utilization of GPS tools as day to day ways of working.
- Level 1 audit completion & closure of deviations in 25 days.
- Completion of safety incidence investigation in 10 days.
- No open ZAP> 90 days pending for closure.
Qualifications we seek in You for FLL laboratory in GSK!
M.Sc /B.Pharm/ M.Pharm (Science Graduate/post Graduate)
- Area of Specialization : Science/Pharmacy
- Job-Related Experience:
5+ years experience in Pharmaceutical Plant
- Other Job-Related Skills/Background
- Advanced knowledge of computer software & potency in use of computer software (Word, Excel, Powe Point).
- Resource Planning
- Problem Solving
- Effective communication skills
- Ability to build relationships (Team building ) at all levels and across functions.
- Have Influencing skilled & IR issue handling.
At GSK we value diversity (Gender, LGBTQ +, PwD etc.) and treat all candidates equally. We aim to create an inclusive workplace where all employees feel engaged, supportive of one another, and know their work makes an important contribution.
- LI-GSK
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 organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.
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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.
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Possible interview Question may be asked for FLL laboratory in GSK
- Can you explain your experience with flow cytometry, luminex, and ligand binding assays?
Answer: In my previous role, I gained extensive experience in performing flow cytometry, luminex, and ligand binding assays. I am proficient in operating flow cytometers and analyzing flow cytometry data to characterize and quantify cells or particles. I have also worked with luminex technology to measure multiple analytes simultaneously and have performed ligand binding assays to assess the interactions between molecules of interest.
- How do you ensure the accuracy and reliability of results in flow cytometry, luminex, and ligand binding assays?
Answer: Accuracy and reliability are crucial in laboratory assays. To ensure this, I meticulously follow standard operating procedures and protocols for sample preparation, assay setup, and data acquisition. I perform thorough quality control checks, including the use of appropriate controls and calibration standards. Regular instrument maintenance, calibration, and troubleshooting are also essential to maintain accurate and reliable results.
- Can you describe your experience in data analysis and interpretation for flow cytometry, luminex, and ligand binding assays?
Answer: I have a strong background in data analysis and interpretation for these assays. I utilize specialized software to analyze flow cytometry data, including gating strategies, population analysis, and statistical analysis. For luminex and ligand binding assays, I employ appropriate curve-fitting models, calculate analyte concentrations, and interpret the results based on established assay parameters and validation criteria.
- How do you handle challenges or issues that arise during laboratory experiments or data analysis?
Answer: Challenges are common in laboratory work, and I approach them by maintaining a systematic and analytical mindset. When faced with challenges, I troubleshoot and investigate the root cause, consulting relevant literature and seeking guidance from colleagues or supervisors. I maintain clear documentation of troubleshooting steps and solutions for future reference. Collaboration and communication with the team are crucial to resolving challenges efficiently and ensuring the accuracy of results.
5. Can you describe your knowledge of laboratory safety protocols and your commitment to maintaining a safe working environment?
Answer: I have a deep understanding of laboratory safety protocols and maintain a strong commitment to maintaining a safe working environment. I strictly adhere to standard operating procedures for handling hazardous materials, biohazardous waste disposal, and personal protective equipment usage. I actively participate in safety training programs and ensure that safety measures are implemented throughout laboratory operations.
