Ra I Product Quality

2 months ago

Ahmedabad Gujarat, India BAXTER Full time

**This 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.

**Job Summary**:
**Responsibilities**:
Major responsibilities are as mentioned below but not limited to,
- Review and approval of technical documents of GPRD which includes analytical and formulation documents.
- Perform tool based investigations for CMO, R&D, plant, and contract labs to ensure compliance with cGxP regulations and guidelines.
- Review and approve QMS documents such as change controls, investigations, and audit reports in TrackWise.
- Handle market complaints and manage the quality management system (change control, CAPA, deviations, OOS, etc.).
- Coordinate with external/internal auditors and ensure timely closure of audit findings.
- Provide expert advice on cGxP regulations and guidelines.
- Prepare, review, and implement SOPs.
- Carry out internal quality audits of R&D lab and maintain Good Laboratory practices.
- Review and approval of risk assessments for commercial product support.
- Risk management, human factor, accelerated aging study, pFMEA, distribution study, sterilization assurance, etc. documents review.
- Monitor and evaluate the performance of process and analytical methods to identify any issues or deviations.
- Collaborate with other departments to ensure that all methods and procedures are compendial compliant.
- Compliance verification through GEMBA walks.
- Handling of SNC’s (Supplier Notification of change).
- Review and approval of Packaging development documents and data along with procedures.
- Review and approval of registration and commercial stability data along with trend analysis.

**Requirements**:

- Master or Bachelor's degree in Life Sciences, Pharmaceutical Sciences, or a related field.
- At least 8-15 years of experience in Quality Assurance or related field.
- In-depth knowledge and understanding of cGxP regulations and guidelines.
- Excellent communication and interpersonal skills.
- Strong technical knowledge, investigational and problem-solving skills.
- Ability to work in a team environment.
- Proficient in Microsoft Office and other quality management systems.
- Proficiency in Microsoft Office and TrackWise8.
- Continual system improvement and cGxP mindset

**Reasonable Accommodations**

**Recruitment Fraud Notice**

Baxter 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.

148448

  • Executive - QA and Ra (Level I/ Ii)

    5 months ago

    Vadodara, Gujarat, India OrthoHeal Full time

    JOB ID: 240204 Job family Regulatory Job Type Full Time Location Vadodara, Gujarat Nature of Work On-site Company Name JC OrthoHeal Private Limited **Summary**: Executive (QA, RA) (Level I/ II) will work with the regulatory team and formulate or implement regulatory affairs policies and procedures. **Key Roles and **Responsibility** - Formulate or...

  • Spec, Ra

    5 months ago

    Ahmedabad, Gujarat, India BAXTER Full time

    **This 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...

  • Spec, Ra

    5 months ago

    Ahmedabad, India BAXTER Full time

    **This 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...

  • Regulatory Affairs Executive

    5 months ago

    Ahmedabad, Gujarat, India Sunrise Remedies Full time

    Sunrise Remedies Job Opening for Regulatory Affairs Executive (RA). **Experience**: 0 To 1 Year **(Fresher and Experience Can Also Apply)** **Industries**: Pharmaceutical Company **Education**: B.Sc. / M.Sc / B.Pharm / M.Pharm **Job Location**: Santej Ahmedabad **Key Responsibilities**: - Regulatory Affairs Specialists assist in obtaining and maintaining...

  • Regulatory Affairs Executive

    5 months ago

    Ahmedabad, Gujarat, India Aegis Lifesciences Pvt Ltd Full time

    Title/Designation: Regulatory Executive Based at: Ahmedabad Industry: Medical Devices manufacturing (Class III) Qualification: Postgraduate or equivalent in Pharma/Medical Devices domain Experience: more than 2 years will be preferred Reports to: Head of RA / RA Manager **About us**: Aegis Lifesciences, established in 2008, is a distinguished...

  • Senior Quality Assurance Engineer for IoT Products

    2 weeks ago

    Ahmedabad, Gujarat, India CIMCON Software I Pvt Ltd Full time

    We are seeking a highly skilled Senior Quality Assurance Engineer for IoT Products to join our team at CIMCON Software I Pvt Ltd. The successful candidate will be responsible for collaborating with cross-functional teams to understand product requirements, developing comprehensive testing plans, and ensuring adherence to schedules and budgets.Key...

  • Ra Pl

    5 months ago

    Madhapar, Rajkot, Gujarat, India HDFC Bank Full time

    Please enter job descript**Group Company**: HDFC Bank Limited **Designation**: RA PL & BL - Emerging-Sales Officer-BL (54_114_100405) **Office Location**: Madhapar **Position description**: - RA PL & BL - Emerging-Sales Officer-BL **Primary Responsibilities**: - To source Business from the Branch Customer base / Open Market. - Visiting the Allocated...

  • Oper I, Production

    5 months ago

    Ahmedabad, Gujarat, India BAXTER Full time

    **This 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...

  • Jr. UI Designer

    2 weeks ago

    Ahmedabad, Gujarat, India I Can Infotech Full time

    **Company Description** I Can Infotech is a global software development company headquartered in Toronto, Canada, specializing in customized software solutions for businesses. By leveraging cutting-edge technology like AI and ML, we optimize and scale products to meet the unique needs of each client. Our solutions are tailored for various industries such as...

  • QA Ayurvedic

    5 months ago

    Ahmedabad, Gujarat, India Sunrise Remedies Full time

    Sunrise Remedies Job Opening for QA Ayurvedic. **Education**: M.Sc /B. Pharm / M. Pharm **Experience**: 0 -2 Year Experience in Production. *Freshers can apply. **Industries**: Pharmaceutical Company **Job Location**: Santej Ahmedabad. **Responsibilities**: - Review the Batch records for completeness and compliance for batch release. - To prepare the...

  • Research Associate I

    4 weeks ago

    Ahmedabad, Gujarat, India Baxter Full time

    About BaxterBaxter is a leading global healthcare company that saves and sustains lives. Our mission is to improve healthcare outcomes for millions of patients worldwide.Job Title: Research Associate IWe are seeking a highly motivated and experienced Research Associate I to join our team in Ahmedabad. As a Research Associate I, you will play a critical role...

  • Research Associate I

    5 months ago

    Ahmedabad, Gujarat, India BAXTER Full time

    **This 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...

  • Quality Controller

    5 months ago

    Ahmedabad, Gujarat, India Fact Personnel Pvt Ltd Full time

    **Quality controller** Salary - approx 40 k/month Experience-1-2 yrs I**ndustry-specific - food industry preferable** Gender - Male Base location - Changodar, Ahmedabad **Responsibilities: - ** - **Devise procedures to inspect and report quality issues at all work locations**: - **Monitor all operations that affect quality.**: - **Supervise and guide...

  • Student Internship

    2 months ago

    Vastrapur, Ahmedabad, Gujarat, India I Vision Infotech Full time

    Job description **Company Description** I Vision Infotech is a full-fledged IT company based in Ahmedabad, India, delivering high-quality, cost-effective, reliable web and e-commerce solutions to both domestic and international clients. Established in 2011, I Vision Infotech provides services to clients in India, USA, Malaysia, Australia, Canada, and the...

  • Student Internship

    3 weeks ago

    Vastrapur, Ahmedabad, Gujarat, India I Vision Infotech Full time

    Company Description I Vision Infotech is a full-fledged IT company based in Ahmedabad, India, delivering high-quality, cost-effective, reliable web and e-commerce solutions to both domestic and international clients. Established in 2011, I Vision Infotech provides services to clients in India, USA, Malaysia, Australia, Canada, and the United Kingdom. The...

  • Production Engineer Position

    2 weeks ago

    Ahmedabad, Gujarat, India Prasad Group Of Companies Full time

    We are pleased to inform you that your profile has been shortlisted for the position of Production Engineer at Prasad Group of Companies.We are a leading manufacturer of plastic processing machineries with a strong presence in the plastics auxiliary equipment industry. Our company is known for producing world-class products and providing excellent technical...

  • IOT Quality Assurance Specialist

    3 weeks ago

    Ahmedabad, Gujarat, India CIMCON Software I Pvt Ltd Full time

    About the Role:CIMCON Software I Pvt Ltd is seeking a skilled IOT Quality Assurance Specialist to join our team. As an IOT Quality Assurance Specialist, you will be responsible for collaborating with cross-functional teams to understand product requirements, developing comprehensive testing plans, and ensuring adherence to schedules and budgets.Key...

  • Product Development Manager

    2 weeks ago

    Ahmedabad, Gujarat, India Network Techlab (I) Pvt. Ltd Full time

    Key ResponsibilitiesAs a Technical Sales Support Specialist at Network Techlab (I) Pvt. Ltd, you will play a key role in assisting the Sales team.One of your primary responsibilities will be to conduct site surveys at client locations, where you will have the capability to create accurate Bill of Quantities (BOQs).Additionally, you will be required to...

  • Student Internship

    1 month ago

    Vastrapur, Ahmedabad, Gujarat, India I Vision Infotech Full time

    Company Description I Vision Infotech is a full-fledged IT company based in Ahmedabad, India, delivering high-quality, cost-effective, reliable web and e-commerce solutions to both domestic and international clients. Established in 2011, I Vision Infotech provides services to clients in India, USA, Malaysia, Australia, Canada, and the United Kingdom. The...

  • Student Internship

    3 weeks ago

    Vastrapur, Ahmedabad, Gujarat, India I Vision Infotech Full time

    Company Description I Vision Infotech is a full-fledged IT company based in Ahmedabad, India, delivering high-quality, cost-effective, reliable web and e-commerce solutions to both domestic and international clients. Established in 2011, I Vision Infotech provides services to clients in India, USA, Malaysia, Australia, Canada, and the United Kingdom. The...