34 Quality Assurance Manager jobs in Bhubaneswar

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.

• Perform qualitative and quantitative analyses on raw materials, in-process samples, and finished products using various analytical techniques (e.g., HPLC, GC, UV-Vis spectroscopy, titrations).
• Ensure all testing is conducted in compliance with Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP).
• Validate analytical methods and instrumentation according to regulatory guidelines.
• Maintain accurate and detailed records of all laboratory tests, results, and observations.
• Prepare certificates of analysis (CoA) for raw materials and finished products.
• Calibrate and maintain laboratory equipment, ensuring optimal performance and accuracy.
• Investigate out-of-specification (OOS) results and deviations, identifying root causes and implementing corrective actions.
• Participate in internal and external audits of the quality control laboratory.
• Stay updated with the latest pharmacopeial standards (e.g., USP, BP, IP) and regulatory requirements.
• Assist in the development and improvement of quality control procedures and protocols.
• Collaborate with production, R&D, and regulatory affairs departments to address quality issues.
• Ensure proper handling and disposal of chemicals and hazardous materials.
• Contribute to a culture of continuous improvement within the quality department.

• Bachelor's or Master's degree in Chemistry, Pharmaceutical Chemistry, or a related field.
• Minimum of 3-5 years of experience in pharmaceutical quality control or analytical testing.
• Proficiency in using analytical instruments such as HPLC, GC, UV-Vis, FTIR, etc.
• Strong knowledge of pharmacopeial standards and regulatory guidelines (e.g., ICH, FDA, GMP).
• Excellent understanding of analytical chemistry principles.
• Meticulous attention to detail and accuracy in testing and record-keeping.
• Ability to work independently and as part of a team in a laboratory setting.
• Good problem-solving and critical-thinking skills.
• Strong written and verbal communication skills.
• Experience with laboratory information management systems (LIMS) is a plus.

• Develop, implement, and maintain quality control procedures and standards.
• Conduct comprehensive inspections and testing of raw materials, in-process products, and finished goods.
• Analyze quality data, identify trends, and prepare detailed reports for management.
• Lead root cause analysis for quality deviations and implement effective corrective and preventive actions.
• Ensure compliance with relevant industry standards and certifications.
• Collaborate with engineering and production teams to resolve quality-related issues.
• Manage and update quality documentation, including SOPs and work instructions.
• Oversee calibration and maintenance of quality control equipment.
• Mentor and guide junior quality control personnel.
• Contribute to the continuous improvement of manufacturing processes and product quality.

• Bachelor's degree in Engineering (Mechanical, Industrial, or related field).
• Minimum of 5 years of experience in quality control or quality assurance within a manufacturing environment.
• Strong knowledge of quality management systems (ISO 9001) and statistical process control (SPC).
• Proficiency in data analysis and problem-solving techniques.
• Excellent communication, interpersonal, and teamwork skills.
• Experience with lean manufacturing principles is a plus.

• Perform a wide range of analytical tests on raw materials, in-process samples, and finished pharmaceutical products using various laboratory techniques (e.g., HPLC, GC, UV-Vis, IR spectroscopy, dissolution testing).
• Develop, validate, and implement analytical methods according to regulatory guidelines and internal procedures.
• Analyze and interpret test results, ensuring accuracy and completeness.
• Prepare detailed reports on testing activities, results, and deviations.
• Troubleshoot and resolve analytical method issues and laboratory instrument problems.
• Maintain laboratory equipment and ensure proper calibration and qualification.
• Ensure compliance with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and other relevant regulatory standards.
• Collaborate with R&D, manufacturing, and regulatory affairs departments to support product development and issue resolution.
• Participate in internal and external audits as required.
• Maintain accurate and up-to-date laboratory records and documentation.
• Stay current with scientific literature, industry trends, and advancements in pharmaceutical quality control.

• Master's or Ph.D. in Chemistry, Pharmaceutical Sciences, Analytical Chemistry, or a related field.
• Minimum of 5 years of experience in pharmaceutical quality control or analytical development.
• Extensive hands-on experience with analytical instrumentation (e.g., HPLC, GC-MS, LC-MS).
• Proficiency in method development, validation, and transfer.
• Thorough understanding of GMP/GLP guidelines and regulatory requirements (e.g., FDA, EMA).
• Excellent analytical, problem-solving, and critical thinking skills.
• Strong report writing and data interpretation abilities.
• Ability to work independently with minimal supervision and manage time effectively in a remote setting.
• Excellent organizational skills and attention to detail.
• Proficiency in laboratory information management systems (LIMS) and relevant software.

• Develop, implement, and manage comprehensive quality control strategies and procedures.
• Oversee all laboratory testing and analytical activities to ensure product quality and compliance.
• Ensure adherence to GMP, GLP, and other relevant pharmaceutical regulations.
• Manage and lead a remote team of Quality Control analysts, providing guidance and training.
• Review and approve batch records, analytical data, method validation reports, and stability studies.
• Investigate deviations, out-of-specification (OOS) results, and customer complaints, implementing CAPA.
• Conduct risk assessments and implement quality improvement initiatives.
• Collaborate with R&D, Manufacturing, and Regulatory Affairs to ensure quality standards are met throughout the product lifecycle.
• Stay updated on current regulatory guidelines and industry best practices.
• Prepare for and participate in internal and external audits.
• Manage QC budget and resources effectively.

• Master's or Ph.D. in Pharmaceutical Sciences, Chemistry, Biology, or a related field.
• Minimum of 8-10 years of progressive experience in pharmaceutical quality control and assurance.
• Extensive knowledge of GMP, GLP, ICH guidelines, and other relevant regulatory requirements.
• Proven experience in managing QC laboratories and teams.
• Proficiency in analytical techniques (e.g., HPLC, GC, spectroscopy, dissolution testing).
• Strong understanding of data integrity principles and documentation practices.
• Excellent leadership, problem-solving, and decision-making skills.
• Ability to manage multiple projects and priorities in a remote environment.
• Strong communication and interpersonal skills for effective collaboration.

Job Title: Quality Control (Microbiology + Chemistry) Trainer

Location: Remote

Job Type: Part-time

Job Summary:

We are seeking an experienced QC (Microbiology and Chemistry) Trainer to design and deliver technical training programs , mentor professionals , and support their career success in the pharmaceutical and healthcare industries. This role involves hands-on guidance , GMP/GLP compliance training , documentation mentoring , and interview preparation .

Key Responsibilities:

• Deliver training on QC techniques:
• Microbiology: Environmental Monitoring (EM), Sterility Testing, Bioburden
• Chemistry: HPLC, GC, UV-Vis Spectroscopy, FTIR
• Mentor and coach on GMP, GLP, Data Integrity & Regulatory Compliance
• Guide candidates on laboratory practices, documentation & audit readiness
• Prepare real-world case studies on OOS, OOT investigations & CAPA handling
• Train on SOP creation, deviation management & lab report preparation
• Conduct mock interviews (Technical + HR) with actionable feedback
• Support career enablement: Resume building, project story development, certification guidance (ASQ, Microbiology, Analytical Chemistry)

Requirements:

• 10+ years of experience in QC (Microbiology + Chemistry) in a regulated Pharma / Healthcare environment
• Hands-on expertise with laboratory equipment & analytical techniques (HPLC, GC, UV, FTIR)
• Strong knowledge of regulatory standards: FDA, WHO, ICH, MHRA
• Experience with GMP, GLP, Data Integrity, CAPA investigations, OOS/OOT analysis
• Training/mentoring experience with excellent presentation skills
• Strong documentation skills and ability to prepare audit-ready records