Executive I, Quality Control at Baxter International

Ahmedabad, Gujarat, India

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Pharmaceuticals, Medical DevicesIndustries

Requirements

Ability to prepare specifications, Standard Test Procedure (STP), and formats for Certificate of Analysis (COA), Analysis report, and Calculation sheet based on reference ADL documents
Knowledge of updating addendum of index for new specifications and updating Specification index on a quarterly basis
Experience in providing COA based on QC requirements
Proficiency in initiating DCR/CCM for updating specifications, STP, and calculation sheets
Capability to ensure availability of updated calculation sheets in Controlled Form System
Experience in initiating departmental NCR if any
Ability to close DCR/CCM/NCR/CAPA tasks in a timely manner
Knowledge of ensuring document records align with cGMP and regulatory compliance
Skills in preparing/updating departmental Standard Operating Procedures (SOPs)
Experience in reviewing, releasing, and setting effective dates of documents in TcU
Ability to provide training for new TcU users
Proficiency in linking new documents in respective departments in CFS
Capability to maintain data of document inventory and ensure documents are well-arranged and maintained in central record room as per SOP

Responsibilities

Prepare specifications, Standard Test Procedure (STP), and formats for Certificate of Analysis (COA), Analysis report, and Calculation sheet based on reference ADL documents
Update addendum of index for new specifications and update Specification index on a quarterly basis
Provide COA based on QC requirements
Initiate DCR/CCM for updating specifications, Standard Test Procedure (STP), and calculation sheets
Ensure availability of updated calculation sheets in Controlled Form System
Initiate departmental NCR if any
Close DCR/CCM/NCR/CAPA tasks in a timely manner
Ensure all document records are in line with cGMP and regulatory compliance
Prepare/update departmental Standard Operating Procedures (SOPs)
Review, release, and set effective date of documents in TcU
Provide training for new TcU users
Link new documents in respective departments in CFS
Maintain data of document inventory and ensure all documents are well-arranged and maintained in central record room as per SOP

Skills

Key technologies and capabilities for this role

cGMPQuality ControlCOASTPSOPDCRCCMNCRCAPATcUCFSDocument Control

Questions & Answers

Common questions about this position

What is the employment type for this position?

This is a full-time position.

Is this a remote position or does it require on-site work?

This information is not specified in the job description.

What skills or experience are required for the Executive I, Quality Control role?

The role requires skills in preparing specifications, Standard Test Procedures (STP), COA formats, updating document indexes, ensuring cGMP and regulatory compliance, initiating DCR/CCM/NCR/CAPA, and managing document control systems like TcU and CFS.

What is the company culture like at Baxter?

Baxter's culture is driven by courage, trust, and collaboration, where colleagues are united by the mission to Save and Sustain Lives, empowered to take ownership, and held accountable for exceptional results.

What makes a strong candidate for this Quality Control role?

Strong candidates will have experience with cGMP compliance, document control systems, preparing QC specifications and SOPs, and handling change controls like DCR/CCM/NCR/CAPA.

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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