Clinical Quality Assurance

2 days ago

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

Associate - Clinical Quality Assurance (CQA)

Department: QA - MakroCare and DDi

Job Roles and Responsibilities:

Perform maintenance, review, and approval of company Standard Operating Procedures (SOPs) in compliance with ISO standards and applicable international and national regulations.

Prepare and review Quality Management System (QMS) documents, CQA procedures, and assist in reviewing department SOPs as needed.

Manage SOPs in mLMS, create users, review training records, and escalate non-compliance issues to the Head of CQA or relevant department heads.

Maintain the CQA document repository and archive validation protocols and documents in line with regulatory requirements.

Conduct internal audits of Clinical Research Department activities and ISO requirements, ensuring compliance with ICH-GCP and company procedures.

Provide training to staff on ISO standards and local regulations when necessary.

Control and manage documents, including maintaining master lists and issuing change controls, deviations, CAPAs, amendments, and notes to file.

Update logs for change control, deviations, CAPAs, amendments, and NTFs.

Prepare annual CQA reports and trend analysis, and assist with external audits from clients, certification bodies, or regulatory authorities.

Requirements:

Education: Bachelor's or Master's in Life Sciences (or related field).

Experience: 2-3 years of experience in Clinical Quality Assurance or related roles.

Familiarity with ISO regulations, ICH-GCP guidelines, and QMS.

Experience in conducting internal audits and maintaining regulatory documentation.

Note: Additional responsibilities may be assigned by the Head of Department (HOD).

  • ▷ (3 Days Left) Team Member - Clinical Dqa (developmental Quality Assurance)

    2 weeks ago

    Hyderabad, Telangana, India Dr. Reddy's Laboratories Full time

    Company Description Dr Reddy s Laboratories Ltd is a leading multinational pharmaceutical company based across global locations Each of our 24 000 plus employees comes to work every day for one collective purpose to accelerate access to affordable and innovative medicines because Good Health Can t Wait We started in 1984 with a modest investment 20...

  • Lead - Clinical Quality [Urgent]

    3 days ago

    Hyderabad, Telangana, India Dr. Reddy's Laboratories Full time

    Company Description Dr Reddy s Laboratories Ltd is a leading multinational pharmaceutical company based across global locations Each of our 24 000 plus employees comes to work every day for one collective purpose to accelerate access to affordable and innovative medicines because Good Health Can t Wait We started in 1984 with a modest investment 20...

  • Executive - Quality Assurance & Validation

    4 days ago

    Hyderabad, Madhapur, Telangana, India Makro Group Full time ₹ 20,00,000 - ₹ 25,00,000 per year

    QUALITY ASSURANCE & VALIDATION Responsible for development, implementation, and effectiveness of quality strategies, programs and functions for all products and technical solutions to meet all corporate and regulatory objectives with respect to quality initiatives.Summary: Plans, coordinates and directs activities concerned with DDi QMS, Quality manual,...

  • Lead - Clinical Quality

    6 days ago

    Hyderabad, Telangana, India Dr Reddy's Laboratories Limited Full time ₹ 8,00,000 - ₹ 12,00,000 per year

    Company Description Dr. Reddy's Laboratories Ltd. is a leading multinational pharmaceutical company based across global locations. Each of our 24,000 plus employees comes to work every day for one collective purpose: to accelerate access to affordable and innovative medicines because Good Health Can't Wait.We started in 1984 with a modest investment, 20...

  • Clinical Quality Lead

    19 hours ago

    Hyderabad, Telangana, India Dr Reddys Laboratories Full time ₹ 12,00,000 - ₹ 24,00,000 per year

    Lead - Clinical Quality Company Description Dr. Reddy's Laboratories Ltd. is a leading multinational pharmaceutical company based across global locations. Each of our 24,000 plus employees comes to work every day for one collective purpose: to accelerate access to affordable and innovative medicines because Good Health Can't Wait. We started in 1984...

  • Quality Assurance Auditor

    1 week 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...

  • Lead - Clinical Quality

    6 days ago

    Hyderabad, Telangana, India Dr. Reddy's Laboratories Full time ₹ 12,00,000 - ₹ 24,00,000 per year

    Dr. Reddy's Laboratories Ltd.is a leading multinational pharmaceutical company based across global locations. Each of our 24,000 plus employees comes to work every day for one collective purpose: to accelerate access to affordable and innovative medicines becauseGood Health Can't Wait.We started in 1984 with a modest investment, 20 employees and a bold...

  • Quality Assurance

    1 week ago

    Hyderabad, Telangana, India Saaki Argus & Averil Consulting Full time

    **About Client**: A leading BPO Organization Role : Quality Assurance A. Experience and Skill - Education: Under Graduated Degree and/or Graduate with equivalent experience in Finance/Accountancy/Economics/Statistics. - Should have 2 Years of experience in the BFS Domain Preferably Investment or Wealth & Asset Management activities Asset set up, pricing,...

  • Clinic Receptionist

    1 week ago

    Hyderabad, Telangana, India BodyCraft Spa & Salon Full time

    **Corporate Operations Executive**: 1. Overseeing daily operational processes to ensure that outlets are adhere to operational procedures and standards. 2. Responsible for training and guiding clinic staff, ensuring they possess professional knowledge and skills, and assisting them in achieving performance goals. 3. Conducting performance evaluations,...

  • Quality Assurance Executive

    1 week ago

    Hyderabad, Telangana, India Archeesh Healthcare Pvt Ltd Full time

    Archeesh Healthcare is looking for two skilled professionals to join our Quality Assurance department. If you have 0-3 years of experience Executive & Sr.Executive in Quality Assurance and can quickly integrate into our team, we want to hear from you! Job Descriptions: - Perform the Line clearance procedure for Dispensing, Manufacturing, Filling & Packing...