Supv , Quality Control
- Baxter
- 10 to 15 Yrs
- Ahmedabad
- 5 years ago
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Job Description
Supv , Quality Control Apply Now Save JobThis is where you save and sustain lives
At 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. You'll feel a sense of purpose throughout the organization, as we know our 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.
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.
- Manage QC Chemistry section activities and staff members to accomplish responsibilities. Ensure daily verification activities are performed per SOP. Prepare and Review daily reports from staff documenting completion of tasks as assigned.
- Conduct daily morning meetings with the section to include the review and allocation of daily work schedules. Manage the reassignment of tasks in the event of a staff member absence.
- Manages Analysts, Reviewers, and staff within one QC Chemistry section across all shifts to verify and ensure all daily QC Chemistry testing tasks are completed per schedule and in compliance with SOPs and batch record requirements.
- Work with Analysts and Reviewers to implement compliant GMP and Good Documentation Practice (GDP) practices, review issues and impact of the same, and take corrective actions.
- Review and approve SOPs and Standard Formats for executing QC Chemistry work tasks ensuring these are current and meet company and international regulations.
- Establish and exercise authorities and responsibilities to monitor and report the analytical testing results.
- Review and Approve testing and monitoring to assure quality of raw materials, in-process products, finished products, and packaging materials.
- After review of completed Test Reports and Standard Formats, submit the results. Notify and initiate appropriate QMS event occurrence sequence if the reported data is out of trend or out of specifications. Escalate to the Department Head to determine a course of action for additional review and investigation.
- Review and approve documentation in assigned section daily and identify any non-conformances or errors and omissions with the Test Reports and Standard Formats and associated data.
- Report and escalate as appropriate critical non-conformances immediately to the QC Lab Department Head, IPQA, QMS and Production team.
- Manage Chemical lab to ensure that all required batch record entries and associated documentation have been completed accurately and on time.
- Periodically check selected GMP records of raw data, GMP records of masters and change controls to verify that a robust security measures are being followed for access control and for adequate maintenance of data authenticity and data integrity.
- Review and make request for revisions, if any, to the specifications for product attributes to ensure they are current and meet company and international regulations.
- Regularly review critical quality attributes of components and products and monitor/review OOT data maintained by staff members from assigned section to proactively identify product quality attribute shifts.
- Identify and Review GDP issues, analyze any impact on the product quality, strength, identity and efficacy, periodically review for data authenticity and data integrity and suggest corrective actions, to minimize repeat findings.
- Perform daily and biweekly laboratory walk-through and as needed reviews to monitor and maintain sustained GMP compliance.
- Monitor periodic trends and implement effective CAPAs that lead to a reduction in adverse trends year-on-year.
- Respond promptly to information related to ANDA templates and associated queries received from IRA function as requested.
- To be involved in Investigations Management of OOSs, OOTs, LERs, Deviations, CCNs, Customer Complaints, CAPA
- Notify QC-Chemistry Department Head of any major inquiries and/or specific information requests. Immediately escalate any data integrity related issues to the Department Head.
- Identify and quantify areas of potential quality improvement in processes, systems and/or documentation and present to Department Head.
- Manage verification of production related QC Chemistry tasks in a manner to be ready every day for a regulatory inspection visit or internal/external audits.
- Demonstrate section performance in substantial compliance during regulatory inspections.
- Implement, maintain, and approve systems, procedures, and standards to maintain, monitor, and continuously improve the state of quality and GMP compliance of the QC-Chemistry Section regarding testing of Raw Material, In Process Products, Finished Products, and Packaging Materials.
- Preferred Education is Graduate and Post Graduate in Science and should have 10-15 years of experience in Pharma field Quality control department.
Reasonable Accommodations
Baxter 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 Am*********A@ba***r.com and let us know the nature of your request along with your contact information.
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Employement Type: Full timeIndustry: ManufacturingRole Category: General / Other SoftwareFunctional Area: Not ApplicableRole/Responsibilies: Supv , Quality ControlContact Details:
Company: Baxter IndiaLocation(s): Ahmedabad
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Baxter
A leader in healthcare for more than 75 years. Baxter assists healthcare professionals and their patients with treatment of complex medical conditions. Information on our business and leadership is available here.
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