Baxter QA Executive Recruitment 2021 – Candidates Apply Online
Baxter announces job opening for candidates with masters and bachelor’s degrees in pharmacy. Pharma job opening 2021. Pharma job 2021. B Pharma job opening 2021. M Pharma job opening 2021. Check out all the details on the same below:
At Baxter, they are deeply connected by their mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You’ll feel a sense of purpose throughout the organization, as they know their work improves outcomes for millions of patients. Baxter’s 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.
Job Title: Sr Exec, QA – Doc Control
Preferred Educational Qualification: Bachelor or master in Pharmacy with 3 to 5 yrs of relevant industrial experience.
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 stamp; 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 the 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.
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