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Assoc, Quality Control - FPIPPT

2.00 to 6.00 Years   Ahmedabad   24 Jul, 2021
Job LocationAhmedabad
EducationNot Mentioned
SalaryNot Disclosed
IndustryManufacturing
Functional AreaOperations Management / Process Analysis
EmploymentTypeFull-time

Job Description

Assoc, Quality Control - FPIPPTApply Now Save JobThis is where you save and sustain livesAt Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. Youll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.Baxters products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.Join us at the intersection of saving and sustaining lives where your purpose accelerates our mission.

  • To perform the tests as per the specification & standard test procedure and record the necessary results in respective documents.
  • To investigate failure of finished product (FP) or In-process (IP) product, in case of any out of specification (OOS) or laboratory incident or non-conformity and take corrective and preventive actions.
  • To carry out the calibration of all the analysis instruments as per the schedule.
  • To prepare reagents and volumetric solution and standardize it.
  • To perform periodic observation of retained sample.
  • To raise and implement change control or document change request wherever necessary.
  • To perform chemical analysis.
  • To assess the results of testing of In-process sample and finish products to ensure alignment with standard operating procedure (SOP) and regulatory guidelines.
  • To review results of the tests against the specification & standard test procedure performed by team members.
  • To investigate out of specification (OOS), Non-conformity and Laboratory Incident Report (LIR) related to In-Process Product Testing (IPPT) & Finished Product Testing (FP) and take corrective and preventive actions.
  • To check and verify standardization and preparation of reagents and volumetric solution.
  • To review periodic observation of retained sample done by team members.
  • To follow and ensure Good Laboratory Practices (GLP), Good Documentation Practices and Good Manufacturing Practices (GMP) inside Quality Control.
  • To ensure availability the working & impurities standards as per various pharmacopoeias.
  • To support & guide team members in implementing change control, Corrective and preventive actions (CAPA) and check effectiveness of CAPA, give suggestions wherever necessary.
  • To guide and support team members for performing all test for in-process product & finish product as per the specification and schedule.
  • To train team members on current Good Manufacturing Practices (cGMP) and Good Laboratory Practices (GLP) with support from Sub-Department Manager.
  • To assist Sub-Department Manager in preparation of SOP and give suggestions to improve system performance.
  • To check, verify and review the calibration of all the analysis instruments whether performed as per the schedule.
  • To check completion of method transfer successfully in coordination with Analytical Development Lab (ADL) Department.
  • To make entry into LIMS
Reasonable AccommodationsBaxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.040531Apply Now Save Job,

Keyskills :
standard operating procedurecontinuous improvement facilitationmusic makingchange controlquality controlproduct testingmethod transferpreventive actionsdocumentation practicesanalytical development

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