52 Quality Assurance Manager jobs in Bhubaneswar

• Develop, implement, and maintain robust Quality Assurance (QA) systems in accordance with cGMP, ICH, and other relevant regulatory guidelines.
• Oversee the review and approval of batch records, validation protocols, and other critical quality documents.
• Conduct internal audits and support external regulatory inspections (e.g., FDA, EMA).
• Manage deviations, CAPAs (Corrective and Preventive Actions), and change control processes.
• Review and approve quality-related investigations and ensure timely closure.
• Develop and deliver training programs for QA personnel and other relevant departments on quality systems and regulatory compliance.
• Monitor and analyze quality metrics, identifying trends and implementing improvement strategies.
• Collaborate with various departments, including R&D, Manufacturing, and Supply Chain, to ensure quality is integrated into all stages of product lifecycle.
• Stay updated with the latest regulatory changes and industry best practices in pharmaceutical quality assurance.
• Lead and mentor the QA team, fostering a culture of quality excellence.

• Bachelor's degree in Pharmacy, Chemistry, Biotechnology, or a related life science field. Master's degree preferred.
• Minimum of 6 years of experience in Pharmaceutical Quality Assurance or Quality Control, with a strong understanding of cGMP regulations.
• Proven experience in developing and implementing QA systems, including SOPs, audits, and CAPA management.
• In-depth knowledge of regulatory requirements and guidelines applicable to the pharmaceutical industry.
• Strong understanding of pharmaceutical manufacturing processes and product development lifecycle.
• Excellent analytical, problem-solving, and decision-making skills.
• Exceptional attention to detail and commitment to maintaining high quality standards.
• Strong leadership, communication, and interpersonal skills.
• Ability to work independently and manage multiple priorities effectively in a remote setting.
• Experience with electronic quality management systems (eQMS) is desirable.

Commitment: Full-Time Contract (30–40 hours per week)

Location: Based in India, Remote – Eastern Time Zone (preferred) or Mountain Time Zone

Reports To: Clinical QA Lead / Director of Quality

Position Overview

We are seeking an experienced QA Specialist / Manager-level contractor to provide day-to-day clinical quality assurance (QA) support across ongoing clinical trials. This individual will play a key role in guiding study teams, maintaining compliance with Good Clinical Practice (GCP) , and ensuring quality oversight. The ideal candidate brings strong experience with Veeva QMS , is highly tech-savvy, and can support clinical operations teams in a fast-paced, remote environment.

Key Responsibilities

• Serve as the primary QA support resource for clinical study teams, ensuring compliance with GCP and internal quality standards.
• Provide QA expertise during study calls, including:
• Protocol deviation meetings
• Risk-based quality management discussions
• Study operations and trial oversight meetings
• Write, review, update, and format standard operating procedures (SOPs) and other quality documentation.
• Manage and track quality processes within Veeva QMS , including document control, training, and CAPA management.
• Address QA-related questions from study teams in real time, providing clear and actionable guidance.
• Support inspection readiness and contribute to continuous improvement of QA systems and processes.
• Partner with cross-functional stakeholders (Clinical Operations, Data Management, Regulatory, etc.) to align on quality expectations and risk mitigation.

Qualifications

• Education: Bachelor’s degree in life sciences, healthcare, or related discipline (advanced degree preferred).
• Experience:
• 5+ years of Clinical Quality Assurance experience with a strong foundation in GCP.
• Prior experience supporting clinical study teams in a QA capacity.
• Hands-on experience with Veeva QMS .
• Technical Skills:
• Proficient in MS Office (Excel, PowerPoint, Word).
• Skilled in technical writing, SOP drafting, and document formatting.
• Soft Skills:
• Excellent communication and interpersonal skills.
• Strong organizational skills with the ability to work independently.
• Availability: Must be available during Eastern or Mountain Time Zone working hours to attend study calls and provide timely QA support.

Contract Opportunity

This is a full-time contract role offering 30–40 hours per week of consistent work. The contractor will act as a core member of the QA function, providing essential support to ongoing clinical programs and ensuring regulatory compliance.

• Conduct thorough inspections of raw materials, in-process goods, and finished products using various measurement and testing tools.
• Verify that products comply with specified standards, blueprints, and technical documents.
• Identify and report any non-conforming products or deviations from quality standards.
• Document inspection results accurately and maintain detailed quality records.
• Collaborate with the production team to implement corrective actions for quality issues.
• Participate in root cause analysis of quality defects and contribute to process improvement initiatives.
• Calibrate and maintain inspection equipment to ensure accuracy and reliability.
• Ensure a clean and organized work environment, adhering to safety regulations.
• Assist in the development and implementation of quality control procedures.
• Stay updated on industry quality standards and best practices.

• High school diploma or equivalent; a diploma or certification in Quality Assurance or a related technical field is preferred.
• Minimum of 3 years of experience as a Quality Control Inspector in a manufacturing environment.
• Proven experience with various inspection techniques and measurement tools (e.g., calipers, micrometers, gauges).
• Familiarity with quality management systems (e.g., ISO 9001) is a plus.
• Strong attention to detail and accuracy.
• Good problem-solving and analytical skills.
• Ability to read and interpret technical drawings and specifications.
• Basic computer skills for data entry and reporting.
• Good communication and teamwork skills.
• Commitment to workplace safety.

• Develop, implement, and manage comprehensive quality control systems and procedures.
• Ensure all manufactured products meet established quality standards, specifications, and regulatory requirements.
• Oversee and coordinate the activities of the quality control team, providing guidance and training.
• Conduct regular inspections and audits of production processes, materials, and finished goods.
• Analyze quality data, identify trends, and implement corrective and preventive actions (CAPA) to address non-conformities.
• Manage product testing and validation processes, ensuring accuracy and reliability of results.
• Collaborate with production, engineering, and R&D teams to resolve quality-related issues.
• Maintain and improve quality management systems (e.g., ISO 9001), ensuring compliance and certification.
• Develop and review quality control documentation, including SOPs and work instructions.
• Monitor supplier quality and conduct supplier audits as necessary.
• Investigate customer complaints related to product quality and implement resolution strategies.
• Prepare quality reports, performance metrics, and trend analyses for management review.
• Stay updated on industry quality standards, regulations, and best practices.
• Drive continuous improvement initiatives in quality assurance processes.
• Manage the calibration and maintenance of quality control equipment.
• Champion a quality-focused culture throughout the organization.

• Bachelor's degree in Engineering (Mechanical, Chemical, Industrial) or a related scientific field.
• Minimum of 5-7 years of experience in quality control or quality assurance within the manufacturing sector.
• Proven expertise in quality management systems, statistical process control (SPC), and Six Sigma methodologies.
• Strong understanding of manufacturing processes and product testing procedures.
• Excellent analytical, problem-solving, and decision-making skills.
• Proficiency in quality control tools and software.
• Strong leadership and team management capabilities.
• Excellent communication, interpersonal, and reporting skills.
• Detail-oriented with a commitment to accuracy and thoroughness.
• Familiarity with relevant industry regulations and standards (e.g., ISO 9001, industry-specific standards).
• Experience with auditing procedures is advantageous.

• Supervise and guide a team of quality control technicians in performing inspections and tests on raw materials, in-process components, and finished products.
• Develop, implement, and maintain quality control procedures and standards in accordance with company policies and regulatory requirements.
• Conduct regular audits of production processes and quality systems to ensure adherence to standards.
• Analyze quality data, identify trends, and recommend corrective actions to address deviations and improve product quality.
• Manage the calibration and maintenance of laboratory equipment and testing instruments.
• Ensure compliance with all relevant quality management systems (e.g., ISO 9001).
• Investigate customer complaints related to product quality and implement appropriate resolutions.
• Collaborate with production and engineering teams to resolve quality issues and implement process improvements.
• Prepare detailed quality reports for management review.
• Train QC personnel on inspection techniques, product specifications, and quality standards.
• Maintain accurate records of all quality control activities.
• Foster a culture of quality awareness and continuous improvement throughout the manufacturing operations.

• Bachelor's degree in a relevant scientific or engineering discipline.
• Minimum of 5 years of experience in quality control or quality assurance within a manufacturing environment.
• Proven experience in supervising and leading a team of QC professionals.
• In-depth knowledge of quality control methodologies, statistical process control (SPC), and analytical techniques.
• Familiarity with quality management systems (ISO 9001) and regulatory requirements relevant to the industry.
• Excellent analytical, problem-solving, and decision-making skills.
• Strong communication and interpersonal skills, with the ability to effectively collaborate with different departments.
• Proficiency in using quality control software and data analysis tools.
• Ability to balance on-site responsibilities with remote administrative tasks.
• Attention to detail and a commitment to maintaining high-quality standards.

• Conduct comprehensive quality inspections on incoming raw materials, in-process materials, and finished products.
• Perform visual, dimensional, and functional testing using various measuring instruments and equipment.
• Interpret engineering drawings, blueprints, and technical specifications to ensure product conformity.
• Identify, document, and report non-conforming products and initiate corrective actions.
• Calibrate and maintain quality control testing equipment.
• Analyze quality data and trends to recommend process improvements.
• Ensure compliance with company quality standards and regulatory requirements.
• Collaborate with production, engineering, and other departments to resolve quality-related issues.
• Train and mentor junior quality control personnel.
• Maintain detailed and accurate inspection records and reports.

• Bachelor's degree in Engineering, Manufacturing Technology, or a related field.
• Minimum of 5 years of experience in quality control within a manufacturing environment.
• Proficiency in using precision measuring instruments (e.g., calipers, micrometers, CMM).
• Strong understanding of quality management systems and methodologies.
• Excellent analytical, problem-solving, and decision-making skills.
• Ability to read and interpret technical documentation.
• Good communication and interpersonal skills.
• Familiarity with statistical process control (SPC) is a plus.

• Conduct comprehensive quality inspections on raw materials, components, and finished products.
• Operate and maintain precision measuring and testing equipment.
• Interpret technical drawings, blueprints, and specifications.
• Document inspection results accurately and maintain detailed quality records.
• Identify, segregate, and manage non-conforming materials and products.
• Participate in root cause analysis of quality deviations.
• Recommend and implement corrective and preventive actions (CAPA).
• Ensure compliance with quality standards and regulatory requirements.
• Collaborate with production and engineering teams on quality matters.
• Support the development and implementation of quality control procedures.

• Proven experience as a Quality Control Inspector or similar role in manufacturing.
• Proficiency in using various inspection tools and techniques.
• Strong understanding of quality management systems (e.g., ISO 9001).
• Ability to read and interpret technical drawings and specifications.
• Excellent analytical and problem-solving skills.
• Detail-oriented with a high level of accuracy.
• Good communication and interpersonal skills.
• Experience with statistical process control (SPC) is a plus.
• Bachelor's degree in Engineering or a related technical field preferred.
• Prior experience in a Senior role is advantageous.