Quality Associate III at Baxter International

Bengaluru, Karnataka, India

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Pharmaceuticals, Medical DevicesIndustries

Requirements

Solid understanding of theories/practices utilized by other disciplines outside the primary area of expertise
In-depth knowledge and understanding of cGxP and related regulations and guidance, including stability-related ICH guidelines, for R&D (product development, design, and safety)
Ability to provide expert advice and/or actively participate in the generation, review, adoption, and interpretation of regulations
Current knowledge of relevant QSRs and other regulatory requirements to ensure compliance in all research, data collection, and reporting activities
Ability to independently plan and execute stability study designs and/or technical tasks that may not be well-defined, have multiple variables, and require advanced techniques within negotiated deadlines
Ability to play a lead role in the evaluation, selection, and adaptation of various techniques/strategies to accomplish business objectives such as quality and cycle-time
Ability to devise new approaches to complex problems through adaptations and modifications of standard technical principles
Ability to incorporate new methods and technologies for improving existing or new products/processes
Ability to develop budgets and activity schedules of limited scope
Ability to maintain focus on meeting both external and internal customer expectations

Responsibilities

Generation of electronic protocols/study building/data entry/data review in LIMS
Maintaining study files
Preparation of stability reports for registration, annual product review, and annual reports for regulatory submissions
Perform stability assessments to support laboratory investigations, product complaints, change controls, and stability chamber excursions
Develop stability study designs for new product development and sustaining product projects
Contribute to technical feasibility analysis of complex research and design concepts
Evaluate results relative to product requirements, definitions, and/or program goals
May provide training and supervision to junior members within the discipline
Routinely provide advice and assistance to team members regarding unique problems

Skills

LIMS

stability assessments

stability study design

data entry

data review

stability reports

regulatory submissions

laboratory investigations

product complaints

change controls

technical feasibility analysis

Baxter International

Provides essential medical products and services

About Baxter International

Baxter International provides a wide range of medical products and services essential for healthcare. The company operates in several areas, including critical care, hospital care, nutritional care, renal care, and surgical care. Its products are used in various settings, from emergency rooms to home healthcare, helping to meet the needs of patients and healthcare professionals. Baxter develops, manufactures, and distributes medical devices, pharmaceuticals, and biotechnology products, generating revenue through sales to healthcare providers and institutions. A key aspect that sets Baxter apart from competitors is its recent acquisition of Hillrom, which enhances its ability to offer comprehensive healthcare solutions. The company's goal is to improve care outcomes and increase access to healthcare through continuous innovation and a focus on patient needs.

Deerfield, IllinoisHeadquarters

1931Year Founded

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Health Insurance

Dental Insurance

Life Insurance

Disability Insurance

Health Savings Account/Flexible Spending Account

Unlimited Paid Time Off

Paid Vacation

Paid Parental Leave

401(k) Retirement Plan

401(k) Company Match

Employee Stock Purchase Plan

Commuter Benefits

Mental Health Support

Risks

Needle-free injection technology could disrupt Baxter's traditional injection-based therapies.

Shift to home healthcare may require Baxter to adapt its product offerings.

Growing digital health importance necessitates further investment from Baxter to stay competitive.

Differentiation

Baxter's acquisition of Hillrom enhances its comprehensive healthcare solutions portfolio.

Strong focus on patient-centric innovation sets Baxter apart in the healthcare industry.

Baxter's partnerships, like with Ayogo, leverage digital health for improved patient outcomes.

Upsides

Baxter's investment in Medically Home aligns with the growing home healthcare market.

Rising demand for personalized medicine offers Baxter opportunities for targeted therapies.

Expansion in telehealth supports Baxter's integrated healthcare solutions strategy.

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