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Sr Exec, QA - Doc Control

3.00 to 5.00 Years   Ahmedabad   15 Jun, 2021
Baxter India
Job LocationAhmedabad
EducationNot Mentioned
SalaryNot Disclosed
IndustryManufacturing
Functional AreaGeneral / Other Software
EmploymentTypeFull-time

Job Description

Sr Exec, QA - Doc ControlApply 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.BMR & BPR preparation

  • To ensure the implementation and maintenance of Current Good Manufacturing Practice (cGMP) standards and all
  • Create MBD and MPD for each new product introduced for manufacturing, whether for regulatory filings (exhibit batches) or for commercial distribution (approved products).
  • Prepare MBD based on initial product transfer input received from CQA/F&D (Draft MBD).
  • Prepare MBDs and MPDs by integrating product specifications from Technical Package (TP) and processing parameters from site.
  • Issue Calculation Sheets, Logbooks, SFs, Protocols, and Reports to the respective plant.
  • Based on approved MBDs and MPDs, production planning schedule, and after generating a batch number assignment, prepare BMR and BPR in Utility Software.
  • Ensure that the approved MBD, MPD, BMRs, BPRs, SOPs, SFs, Protocols/Reports for management of IPQA, QMS, Validation, Microbiology, and QC-Chemistry are prepared, secured, and maintained current in the Utility Software.
  • Once the BMRs/BPRs are prepared, stamp respective pages with green/blue st& verify requirements for supplemental pages or instructions for additional sampling or special testing per the Technical Package (TP), and to Production and Packing respectively, as per SOP.
  • Prepare and maintain departmental SOPs associated with Data Control functions.
  • Issue Calculation Sheets, Logbooks, SFs, Protocols, and Reports to the respective CIL plant.
  • Track return of issued documents to verify submission within defined time limit.
  • Archive executed Calculation Sheets, Logbooks, SFs, Protocols, and Reports in the record room.
  • In case of any request from departments, provide copies of executed Batch Records, Calculation Sheets, Logbooks, SFs, Protocols, and Reports.
  • Verify the audit trail of BMR/BPR utility software against the Issuance Logbook at a 15-day frequency.
  • As applicable, generate, review, and approve SAP codes in support of product manufacturing and record issuance.
  • Issuance of completed records and its storage, achieve & timely disposition.
  • Approved MBD / MPD upload in utility software.
Preferred Educational Qualification: Bachelor or master in Pharmacy with 3 to 5 yrs of relevant industrial experience.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.042549Apply Now Save Job,

Keyskills :
continuous improvement facilitationaudit traildata controlbatch recordsproduct transferregulatory filingsproduction planningproduct manufacturingsapqmsmbdbpr

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