Company: Baxter
Location: Bengaluru, Karnataka
Industry: Pharma/Healthcare/Clinical Research
Job Req #: JR – 141961
Application Deadline: 30th July 2024
Job Description:
Summary: Ensure Quality Assurance for the successful completion of new and improved product design and implementation projects within boundaries of quality, time, and budget. Implement and maintain the Quality System to ensure compliance with the requirements of authorities and internal customers for drugs and medical devices.
Essential Duties and Responsibilities:
- Ensure Quality System processes are correctly implemented on-site to meet requirements for new product development and lifecycle management for drugs and medical devices, including ICH, 21 CFR, EMA, ISO 13485 and 14971, MDSAP, MDR.
- Ensure Quality System processes are correctly implemented on-site to meet requirements for pharmaceutical product testing and release.
- Proven track record of documentation review for accuracy and compliance to procedures, especially in analytical methods development/validation/transfer, stability studies, Design & Development.
- Demonstrate compliance of development processes and change management during audits and inspections, and participate as an auditor in internal audits + follow-up activities.
- Provide guidance on the maintenance of product Design History Files and Risk Management Files according to relevant Quality System and other regulatory requirements for therapeutics and medical devices.
- Interface with Research & Development, Regulatory Affairs, Manufacturing, and other disciplines to represent QA in project teams, with the objective to assure that the project quality objectives are met.
- Act as QA Approver for Laboratory Out of Specification (OOS), Quality System Change Controls (CC), and in Non-conformance or Corrective Action Preventive Action (CAPA).
Candidate Profile:
- University degree in Engineering or Sciences (Pharmacy, Chemistry, Biochemistry, or Chemical Engineering).
- 7 – 10 years in R&D of Pharmaceutical/Medical Devices industry per EU and/or FDA requirements (GLP/GMP/ISO 13485 regulation).
- Experience in drug development, Therapeutic Goods, and GLP environment for conducting nonclinical R&D studies.
- Experience in Quality Initiatives (processes, systems, improvements) is a must.
- Expertise in analytical method development/validation, laboratory activities, or stability studies is an asset.
Technical Skills:
- Strong oral and written communication skills, ability to negotiate, and willingness to participate in team activities.
- Well-organized, meticulous attention to detail, and customer-focused with strong interpersonal skills.
- Ability to work independently and with minimal supervision.
- Compliance knowledge in pharmaceutical product development, laboratory control, change control, and CAPA.
- R&D minded.
Language Skills:
- Proficiency in English is required.
Computer Skills:
- Proficient in Microsoft Office applications (Word, Excel, Outlook, SharePoint).
- Experience with Trackwise is an asset.
Experience: 7 – 10 years
Qualification: University degree in Sciences (Pharmacy, Chemistry, Biochemistry, or Chemical Engineering)
How to Apply: Submit your application by 30th July 2024.