Quality Assurance Auditor

7 days ago

Hyderabad, Telangana, India Reqolentquality Labs Full time ₹ 9,00,000 - ₹ 12,00,000 per year

A Quality Auditor is responsible for ensuring that all aspects of the Company's Quality

Management System adhere to regulatory standards and established quality guidelines. This

role is crucial for maintaining the integrity of clinical trial data and protecting the safety of

participants.

Key Responsibilities

* Conducting/Host Audits: Perform internal and host external audits. These audits verify

compliance with Good Clinical Practice (GCP) guidelines, Good Documentation Practices

(GDP), company standard operating procedures (SOPs), and other relevant regulations.

Write up an audit report and track findings.

* Quality Management: Evaluate and help maintain the company's quality management

system (QMS). This includes reviewing quality events, incidents, and complaints to identify

root causes and recommend corrective and preventative actions (CAPAs).

* Documentation and Reporting: Prepare detailed audit reports that document findings,

non-conformities, and recommendations for improvement. Present these findings to senior

management and work with various teams to ensure issues are resolved.

* Regulatory Compliance: Stay up to date with all applicable regulations and guidelines

from bodies like the FDA and the International Council for Harmonisation of Technical

Requirements for Pharmaceuticals for Human Use (ICH). Ensure that these regulatory

requirements are communicated and implemented across the organization.

* Training: Ensure training compliance of quality assurance procedures, GXP guidelines

(such as GCP), and the importance of a quality-focused approach.

Required Skills and Qualifications:

* Education and Experience: A bachelor's degree in a relevant field (e.g., life sciences, or

information technology) or equivalent audit experience. The candidate should possess

working knowledge of US FDA Good Clinical Practices (GCP), Internal Conference of

Harmonization (ICH), Electronic Records; Electronic Signatures (21 CFR part 11) and EU

Annex 11, GDPR, or GAMP 5.

* Analytical Skills: Strong analytical and problem-solving abilities are vital for identifying

discrepancies, evaluating data, and drawing logical conclusions from audit findings.

Attention to Detail: The role demands a meticulous and detail-oriented approach to

reviewing documents, data, and processes.

* Communication: Excellent written and verbal communication skills are necessary to

clearly articulate audit findings and work collaboratively with diverse teams and

stakeholders.

* Knowledge of Regulations: A thorough understanding of GCP, ICH guidelines, and other

relevant clinical trial regulations are a fundamental requirement.

* Certifications: Certifications from professional bodies, such as the American Society for

Quality (ASQ), can be advantageous.

If this role excites you, apply now by sending your resume to with the subject line " Quality Auditor "

  • Quality Assurance Auditor

    24 hours ago

    Hyderabad, Telangana, India QualiTLabs Pvt Ltd Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    Job descriptionA Quality Auditor is responsible for ensuring that all aspects of the Company's Quality Management System adhere to regulatory standards and established quality guidelines. This role is crucial for maintaining the integrity of clinical trial data and protecting the safety of participants.Key ResponsibilitiesConducting/Host Audits: Perform...

  • Quality Assurance(Manager

    5 days ago

    Hyderabad, Telangana, India PKL LIMITED Full time ₹ 6,00,000 - ₹ 12,00,000 per year

    AtPKL LIMITED, we are committed to delivering world-class products with uncompromised quality. To strengthen our Quality team, we are looking for passionate professionals at multiple levels:Quality Assurance Manager / Senior Professional – Lead the QA function, audits, certifications, compliance, and customer quality management.Quality Assurance Engineer ...

  • Manager, Quality Assurance

    3 days ago

    Hyderabad, Telangana, India Tungsten Automation Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    Tungsten Automation's Quality Assurance job family help the company to assure that its products and technology solutions are designed and built in accordance with company standards and customer requirements.A Manager, Quality Assurance provide leadership, training, coaching, and/or mentoring to one or more SQA staff members, including giving input into...

  • Quality Assurance Manager

    3 days ago

    Hyderabad, Telangana, India VIDGAS Science And Technologies Pvt Ltd Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    Company DescriptionVidgas Science and Technologies Private LimitedRole DescriptionThis is a full-time, on-site role for a Quality Assurance (QA) Manager / Dy. Manager located in Kadechur, Karnataka. The QA Manager will oversee and manage the quality assurance processes to ensure compliance with industry standards and company regulations. Responsibilities...

  • Sales Call Auditor

    17 hours ago

    Hyderabad, Telangana, India Frontlines EduTech (FLM) Full time ₹ 2,00,000 - ₹ 6,00,000 per year

    Hi Buddies We are hiring forSales Call Auditorfor our Frontlines EduTech Private Limited.Job Type: Full-timeWork Type:Work From OfficeLocation: Somajiguda, HyderabadExperience: 0 - 1 yearKey Responsibilities:Call Auditing: Evaluate inbound and outbound sales calls for script adherence, quality, and compliance.Reporting: Maintain audit records and share...

  • Quality Assurance Quality Control

    20 hours ago

    Hyderabad, Telangana, India MEDICUBE HEALTH CARE PRIVATE LIMITED Full time ₹ 6,00,000 - ₹ 12,00,000 per year

    Company DescriptionMEDICUBE HEALTH CARE PRIVATE LIMITED is a ISO 13485 certified disposable medical device manufacturing company located in Medical Devices Park, Sultanpur, Hyderabad, Telangana, India. We are dedicated to enhancing healthcare products and ensuring the well-being of health care professionals and patients.Role DescriptionThis is a full-time...

  • Quality Assurance Engineer

    2 weeks ago

    Hyderabad, Telangana, India IntouchCX Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    About the JobWe are looking for a Quality Assurance Engineer to focus on building test cases, handling manual testing, and executing regression testing to maintain software quality standards. The role requires attention to detail, strong analytical skills, and the ability to collaborate with cross-functional teams to ensure optimal software performance.As a...

  • Assistant Quality Assurance Manager

    1 week ago

    Hyderabad, Telangana, India SK Health Care Formulation Private Limited Full time ₹ 2,50,000 - ₹ 7,50,000 per year

    Company DescriptionSK Health Care Formulation Private Limited is a biotechnology company based in Hyderabad, India. The company focuses on biotechnology and healthcare formulations.Role DescriptionThis is a full-time on-site role for a Quality Assurance Officer at SK Health Care Formulation Private Limited in Hyderabad. The Quality Assurance Officer will be...

  • Quality Manager

    1 week ago

    Hyderabad, Telangana, India Cognizant Full time ₹ 1,04,000 - ₹ 1,30,878 per year

    Job Description:The role of Quality Manager (IC role) is responsible for driving Quality Assurance in a customer-centric BPO environment with a strong focus on cloud services support operations. The position requires proven expertise in quality frameworks, compliance standards, and continuous process improvement.Responsibilities:Develop & implement quality...

  • Quality Assurance Engineer

    3 days ago

    Hyderabad, Telangana, India Opentext Full time ₹ 20,00,000 - ₹ 25,00,000 per year

    Your ImpactAs a Sr Quality Assurance Engineer, you will own and perform quality assurance functions of highly complex service from development to production. Will develop functional and performance test plans and more importantly API automation (unit, component and integration). Will work with multiple services team and assist on integrations. You will drive...