Sr Mgr, Quality - QC & Stability

Job Description

Sr Mgr, Quality - QC & StabilityApply 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.

• To ensure appropriate approval or rejection of starting materials, packing materials and intermediate bulk and finished products.
• To ensure that every batch of product meets the defined standards for strengths, identity, safety, purity and quality by various system-driven approaches.
• To ensure appropriate approval system for specifications, sampling instructions, test methods and other quality control procedures and other documents, including amendments.
• To ensure approval and monitoring of contract analysis laboratory.
• To ensure the qualification & maintenance of Quality Control & Stability department, premises and equipment or instruments.
• To ensure that the appropriate validations and calibrations of equipments are carried out.
• To ensure that the required initial and continuing training of personnel is carried out and adapted according to need.
• To ensure appropriate retention of records is in place in Quality Control Department.
• To ensure appropriate monitoring of compliance with the requirements of Good Manufacturing Practice in Quality Control department.
• To ensure appropriate inspection, investigation, and taking of samples, to monitor factors which may affect product quality.
• To participate in management reviews of process performance, product quality and product quality management system and advocating continual improvement
• Ensuring that a timely and effective communication and escalation process exists to raise quality issues to appropriate levels of management.
• To ensure identification & completion of testing performed as per validated methods and ensure proper method transfer as per protocol.
• To provide necessary support related to Non-Conformity Report, Validations, Change Controls, Out of specification, Out of trend, Laboratory Error Report, Risk assessment, Impact assessment, market complaints and relevant CAPA.
• To review and approve Level I, II, III and IV documents like Site Master file, Validation Master Plan, Standard Operating procedures, Validation Protocols before implementation, as appropriate
• To ensure the resources (manpower, instruments, budget etc.) are being utilized properly to meet the requirement of stability analysis.
• To ensure the timely review of the GLP activities like calibration of Instruments.
• To monitor the budget utilization & timely procurement of the columns, standards, chemicals to ensure the analysis completion on time.
• To prepare the Capex & Revenue Budget for the year.
• To review & Approve of the stability protocols as per respective country requirement/commitments to the agency for conducting the stability of products.
• To ensure Stability Study done as per laid down procedure.
• To review & approve the commitment note for stability study as per IRA requirement.
• To ensure the stability samples charging & withdrawal as per the protocol requirements.
• To review the abnormal stability trends for exhibit & commercial products during review of the stability summary.
• To ensure proper escalation of any abnormal trend to NPD/ADL for the exhibit/new products.
• To ensure the proper escalation to CQA/QA of any abnormal trend for commercial products.
• To approve the analytical method transfer protocol & reports as per laid down procedures.
• To resolve any concerns observed during method transfer activity according to cGMP requirement.
• To ensure the completion of the stability sample analysis with cGMP requirement without any data integrity observations.

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.Recruitment Fraud NoticeBaxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice .047225Apply Now Save Job,

Keyskills :
method transferquality management systemrisk assessmentproduct qualityquality controlquality managementmanagement systemimpact assessmentmarket complaintsdata integrity