Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-centre dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; surgery products and anesthetics; and pharmacy automation, software and services. The company’s global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries.
Quality Assurance
Job DescriptionInjectable IPQA, In-process quality check, Batch release, Line clearance and Batch record review
Job Description
• To execute in-process quality assurance activities as delegated by Supervisor and/or shift lead in each shift.
• To perform the line clearance activity at various stages of packaging activity as defined in the Batch Packaging record.
• To perform routine in-process checks, online documentation as defined in batch packing records at visual and packing stage and escalate any nonconformances to shift lead and supervisor and ensure appropriate actions (CAPA) in place.
• To check and ensure challenge test performed at defined frequency for applicable packaging equipment’s.
• To collect the stability sample/Retain Sample/other samples and records the collection detail in BPR and ELN.
• To verify sample / good destruction process and report any gap to Shift Lead or Supervisor and to take corrective and preventive action in coordination with respective functions.
• To ensure the compliance and GDP of logbooks, online documents, records, and other supporting documents related to products manufactured and packed in the plant and data integrity is ensured.
• To perform Acceptance Quality Limit (AQL) of visually inspected product.
• To verify and approve pallet planning approval in PCR system at dispatch area.
• To ensure cGMP compliance during packing and visual inspection process.
• To perform, evaluate and carry out Visual Inspection qualification process.
• To prepare and maintain visual inspection qualification kit and record.
• To carry out stagewise BPR review for batch execution compliance.
• To review and verification of user access management and Audit trail.
• To perform and support in the CPV programme.
• To ensure the handover of shift-to-shift activities and record in Shift charge Handover format/logbook.
• To Perform impact assessment of breakdown maintenance and approve activity in MAXIMO and risk assessment review.
• To participate in investigation, in case of any complaints or non-conformity.• To communicate about any failure or abnormal notification to Supervisor & shift lead for timely escalation and resolution.
• To raise Document Change Request (DCR) and Change Control Management (CCM) and track the same and ensure closure as per Standard Operating Procedure.
• Any other responsibility assigned by shift lead and reporting manager.
Quality Control
Analyst - GLP, Stability, RM-PM FP, Lab instrument knowledge - HPLC, GC, KF, etc., QMS, QC Doc-cell
Job Description
• To carry out the sampling of all the materials according to Standard Operating Procedure (SOP).
• To conduct the testing of Raw Materials and Packing Material according to approved standard test procedure.
• To support Department Head in releasing of Raw Material and Packing Material
• To carry out the calibration of instruments as per the schedule.
• To coordinate with stability department for the working standards as per the guidelines and various pharmacopoeias.
• To ensure the status label on the material and transfer such material in the respective area.
• To prepare reagent & volumetric solution and standardize it.
• To carry out all the necessary tests as per respective specification and procedure and record the results for all the materials.
• To check the Stores and ensure the implementation of GMP norms in the stores.
• To inform to superior immediately in case of any Out of Specification result or Non-conformity or Laboratory Error Report observed or any instrument breakdown.
• To review the sampling activity of all the materials performed by team members.
• To assess the results of testing of Raw Material, Packing Material 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 ensure availability of the working & impurities standards as per various pharmacopoeias.
• To ensure the status label on the material and transfer such material in the respective area.
• To support Department Head, in investigation of out of specification (OOS), non-conformity and Laboratory Error Report (LER) 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) and Good Manufacturing Practices (GMP) inside QC.
• To support & guide team members in implementing change control, Corrective and preventive actions (CAPA) and check effectiveness of CAPA, give suggestions from the Divisional Head if required.
• To train team members on current Good Manufacturing Practices (cGMP) and Good Laboratory Practices (GLP).
• To assist the Department Head in the formation 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 ensure recording of all the data related to the testing online, on day-to-day basis and ensure traceability of the same.
Microbiology Lab
Analyst, Microbial Limit test, Bioburden endotoxin test, Environment monitoring, GLP, sterility test
Job Description
• To ensure closure of control form system of microbiology team by tracking the open CFS forms
• To ensure the completeness of training of microbiology team by tracking the ongoing trainings through BaxU.
• To be responsible for the closure of training request form and completeness of training before SOP effective
• To ensure and update curriculum whenever there is any updation in SOP.
• To ensure the timely archival of document in QA doc cell through Baxcabinet.
• To ensure calibration and validation of instruments in microbiological laboratory through calibration schedules in coordination with Quality Assurance function.
• Participate in GEMBA rounds and supervises system and facilities are complying with GDP and GLP as per the requirements and train employees on such requirements as necessary and sustain GMP compliance in the lab.
• Maintain availability of all the stock always used in Microbiology lab through tracking mechanism and giving requirements to procurement team through weekly/monthly/annual basis.
• Maintain the destruction logbook for the destruction of document of microbiology.
• Perform periodic gap & risk assessment of procedure vs practices and propose alternate method/escalate to the Manager.
• Track the destruction of documents, scrap and bio waste by maintain logbooks.
• Escalate machine related abnormality to the technical department by initiating, tracking and closure of service log through the tool.
• To perform the new instruments /Equipment’s Qualification so as to meet the given standards.
• To perform the review of Laboratory Logbooks and ELN to ensure the correctness of documents.
• To ensure the clean environment for sterile preparation by implementing the Good Manufacturing Practice (GMP) norms as per the international standards and guidelines.
• To do sampling of Water for Injection (WFI), double Reverse Osmosis (DRO), Single Reverse Osmosis (SRO), raw water and pure steam.
• To collect the validation samples as per validation protocol
• To prepare trends of the results obtained
• To qualify the personnel to enter in to the clean room.
• To perform HEPA filter qualification on periodic basis and as and when required
• To operate laboratory instrument or equipment as and when required.
• To initiate non-conformity or Out of Specification in case of abnormality observed.
• To perform data entry for trend analysis of the daily result observed.
• To communicate any failure or abnormal notification to respective Supervisor for their attention and to seek the solution.
• To bring to the notice of Supervisor about the abnormalities in the clean room or manufacturing areas and suggest the preventive and corrective measures in case of such abnormalities as per the guideline.
Job Location : Ahmedabad, Gujarat
Experience : 2 to 6 Years
Education : M.Pharm / M.Sc / B.Pharm / B.Sc
Walk in Interview
Date : 06th and 7th April 2024
Time : 09:00 am to 03:00 pm
Venue : Baxter R&D Center, Prestige Shanti Niketan, Crescent 2, Floor- 9. Thigalarapalya, Hoodi, Bengaluru, Karnataka 560067, India
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