310 Quality Assurance Specialist jobs in Mumbai

Optum is a global organization that delivers care, aided by technology to help millions of people live healthier lives. The work you do with our team will directly improve health outcomes by connecting people with the care, pharmacy benefits, data and resources they need to feel their best. Here, you will find a culture guided by inclusion, talented peers, comprehensive benefits and career development opportunities. Come make an impact on the communities we serve as you help us advance health optimization on a global scale. Join us to start Caring. Connecting. Growing together.

Primary Responsibilities:

Required Qualifications:

At UnitedHealth Group, our mission is to help people live healthier lives and make the health system work better for everyone. We believe everyone-of every race, gender, sexuality, age, location and income-deserves the opportunity to live their healthiest life. Today, however, there are still far too many barriers to good health which are disproportionately experienced by people of color, historically marginalized groups and those with lower incomes. We are committed to mitigating our impact on the environment and enabling and delivering equitable care that addresses health disparities and improves health outcomes - an enterprise priority reflected in our mission.

• Develop, implement, and maintain the Quality Management System (QMS) in accordance with cGMP and other relevant regulatory guidelines.
• Conduct internal audits and participate in external audits (regulatory bodies, clients) to ensure compliance.
• Review and approve batch records, validation protocols, and other quality-related documentation.
• Investigate deviations, out-of-specification (OOS) results, and customer complaints, implementing corrective and preventive actions (CAPAs).
• Monitor manufacturing processes to ensure adherence to standard operating procedures (SOPs) and quality standards.
• Manage change control processes for equipment, materials, and procedures.
• Train personnel on quality assurance principles and cGMP requirements.
• Prepare and present quality metrics and reports to management.
• Stay updated on current regulatory requirements and industry best practices.
• Collaborate with production, R&D, and regulatory affairs departments to resolve quality issues.
• Perform risk assessments and implement mitigation strategies.
• Ensure proper calibration and maintenance of laboratory and manufacturing equipment.
• Oversee product release activities based on documented evidence of quality.

• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science field.
• Minimum of 4 years of experience in pharmaceutical quality assurance or quality control.
• In-depth knowledge of cGMP, ICH guidelines, and other relevant pharmaceutical regulations.
• Experience with QMS, audit procedures, deviation management, and CAPA.
• Strong analytical and problem-solving skills with excellent attention to detail.
• Proficiency in documentation and technical writing.
• Effective communication and interpersonal skills.
• Ability to work independently and as part of a team.
• Experience with pharmaceutical manufacturing processes is highly desirable.
• Familiarity with quality control testing methods is a plus.

Key Responsibilities

• Evaluate and monitor sales discovery meetings (demos), calls, emails, and SMS interactions for quality and compliance.

• Audit closed deals to ensure accurate documentation, ethical practices, and proper sales process adherence.

• Identify and report gaps (AFIs – Areas for Improvement) to enhance team performance and training initiatives.

• Collaborate with sales leadership to develop and refine QA processes, benchmarks, and performance metrics.

• Deliver ongoing feedback to the sales team, highlighting strengths and actionable growth opportunities.

• Work alongside sales managers to identify training needs and implement targeted development programs.

• Conduct data-driven analysis to track trends and recommend strategic improvements.

• Audit sales workflows to ensure consistency, compliance, and regulatory adherence.

• Stay updated on QA best practices, compliance regulations, and evolving sales techniques.

• Support post-sale feedback initiatives such as customer satisfaction surveys to assess sales experience.

• Cultivate a culture of continuous improvement, knowledge-sharing, and quality awareness.

Qualifications

• Bachelor’s degree in Business, Marketing, Psychology, or related field (or equivalent experience).

• Proven experience in sales quality assurance, sales operations, or a related field.

• Strong understanding of the sales cycle, especially within SaaS or B2B environments.• Exceptional analytical and problem-solving skills with acute attention to detail.

• Excellent communication and interpersonal skills.

• Ability to work independently and cross-functionally in a fast-paced, agile environment.

• Proficient in tools such as Google Workspace, MS Office, CRM systems (e.g., Salesforce, HubSpot).

• Familiarity with QA tools and frameworks (ISO standards, Six Sigma, etc.) is a plus.

• Experience in Learning & Development or training delivery is highly desirable.

Preferred Skills

• Sound knowledge of sales methodologies and CRM principles.

• Hands-on experience coaching or training sales professionals.

• Comfort with data visualisation and analysis tools (e.g., Excel, Looker, Tableau).

• Strong organisational skills with the ability to manage multiple audits and reporting timelines.

What We Offer

• Competitive compensation and comprehensive benefits package.

• Paid time off, flexible work policies, and wellness support.

• Access to world-class tools and a modern collaborative environment.

• Opportunities for professional development, growth, and internal mobility.

• A high-performance, inclusive, and mission-driven work culture.

• Develop, implement, and maintain the company's Quality Management System (QMS) in accordance with GMP, ISO, and other relevant regulatory guidelines.
• Conduct internal audits of manufacturing processes, documentation, and facilities to ensure compliance with established procedures and regulations.
• Review and approve critical documents, including batch records, validation protocols and reports, SOPs, and change controls.
• Investigate deviations, out-of-specification (OOS) results, and customer complaints, determining root causes and implementing effective corrective and preventive actions (CAPAs).
• Participate in external audits conducted by regulatory agencies (e.g., FDA, EMA) and customers.
• Develop and deliver training programs on quality assurance principles and GMP compliance to relevant personnel.
• Monitor key quality indicators (KQIs) and provide regular reports to management on the performance of the QMS.
• Collaborate with R&D, manufacturing, and regulatory affairs departments to ensure quality is built into product development and commercial manufacturing processes.
• Manage and maintain controlled documentation systems, ensuring version control and accessibility.
• Stay up-to-date with evolving regulatory requirements and industry best practices.
• Contribute to the continuous improvement of quality processes and systems.

• Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science discipline.
• Minimum of 6 years of experience in pharmaceutical Quality Assurance or Quality Control.
• In-depth knowledge of Good Manufacturing Practices (GMP), ICH guidelines, and relevant regulatory requirements.
• Proven experience with internal and external audits, deviation investigations, and CAPA management.
• Strong understanding of pharmaceutical manufacturing processes, validation, and documentation practices.
• Excellent analytical, problem-solving, and critical thinking skills.
• Exceptional attention to detail and accuracy.
• Strong written and verbal communication skills, with the ability to communicate effectively with cross-functional teams and external auditors.
• Proficiency in using quality management software and standard office applications.
• Demonstrated ability to work independently and manage multiple priorities in a remote setting.
• Experience with sterile product manufacturing and aseptic processing is a significant advantage.

• Ensure compliance with GMP regulations and internal quality policies throughout the pharmaceutical lifecycle.
• Review and approve batch records, ensuring all manufacturing steps are properly documented and executed.
• Investigate deviations, out-of-specification (OOS) results, and customer complaints.
• Manage the change control process, assessing the impact of proposed changes on product quality.
• Conduct internal audits to assess compliance with GMP and identify areas for improvement.
• Develop and implement CAPA plans to address quality issues and prevent recurrence.
• Participate in external audits conducted by regulatory agencies and customers.
• Contribute to the validation and qualification of equipment, processes, and analytical methods.
• Train personnel on GMP requirements and quality procedures.
• Monitor and report on key quality metrics.

• Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science field.
• Minimum of 5 years of experience in Quality Assurance within the pharmaceutical industry.
• In-depth knowledge of GMP, ICH guidelines, and other relevant regulatory standards.
• Proven experience with batch record review, deviation investigation, and change control.
• Strong understanding of pharmaceutical manufacturing processes.
• Excellent analytical, problem-solving, and documentation skills.
• Effective communication and interpersonal skills.
• Ability to work independently and collaboratively in a team environment.

• Review and approve batch records, deviation reports, and change controls to ensure compliance with cGMP (current Good Manufacturing Practices).
• Develop, implement, and maintain quality assurance policies and procedures.
• Conduct internal audits and inspections of manufacturing processes and facilities.
• Participate in external audits from regulatory agencies and clients.
• Investigate quality complaints and non-conformance issues, determining root causes and implementing corrective and preventive actions (CAPAs).
• Monitor and analyze quality data to identify trends and areas for improvement.
• Ensure compliance with global pharmaceutical regulations (e.g., FDA, EMA).
• Collaborate with manufacturing, R&D, and regulatory affairs departments to address quality-related matters.
• Maintain comprehensive and accurate quality documentation.
• Provide training to personnel on quality assurance principles and procedures.
• Assess and approve suppliers and vendors based on quality standards.
• Contribute to the continuous improvement of the Quality Management System (QMS).
• Stay current with industry best practices, regulatory updates, and emerging quality trends.
• Prepare and present quality metrics and reports to management.
• Manage and coordinate validation activities for equipment and processes.

• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science field.
• Minimum of 5 years of experience in pharmaceutical quality assurance or quality control.
• Thorough understanding of cGMP, ICH guidelines, and other relevant pharmaceutical regulations.
• Proven experience in batch record review, deviation investigations, and CAPA management.
• Excellent analytical, problem-solving, and critical thinking skills.
• Strong attention to detail and accuracy.
• Effective communication and interpersonal skills, with the ability to collaborate remotely.
• Proficiency in using quality management software and standard office applications.
• Ability to work independently and manage multiple priorities in a remote setting.
• Experience with auditing and regulatory inspections is essential.
• Knowledge of pharmaceutical manufacturing processes is required.

• Develop, implement, and maintain comprehensive Quality Management Systems (QMS) for pharmaceutical products.
• Conduct remote internal and external audits of manufacturing sites, suppliers, and contract manufacturers to ensure compliance with GMP and other relevant regulations.
• Lead investigations into quality deviations, out-of-specification (OOS) results, and customer complaints, implementing corrective and preventive actions (CAPAs).
• Review and approve critical quality documents, including batch records, validation protocols and reports, and change controls.
• Provide expert guidance and training to internal teams and external partners on quality assurance best practices and regulatory requirements.
• Manage and oversee the lifecycle of Quality Risk Management (QRM) activities.
• Prepare for and participate in regulatory inspections by health authorities worldwide.
• Monitor key quality metrics and provide regular reports to senior management.
• Stay updated on evolving pharmaceutical regulations and industry trends.
• Contribute to the continuous improvement of quality processes and systems.

• Master's degree in Pharmacy, Chemistry, Biotechnology, or a related life science field.
• Minimum of 8 years of progressive experience in pharmaceutical quality assurance and quality control.
• In-depth knowledge of GMP, GLP, GCP, ICH guidelines, and other relevant international regulatory standards.
• Proven experience in conducting audits, managing deviations, and implementing CAPAs.
• Strong understanding of pharmaceutical manufacturing processes and product development lifecycle.
• Excellent analytical, problem-solving, and decision-making skills.
• Demonstrated ability to lead and mentor teams in a remote setting.
• Exceptional written and verbal communication skills.
• Proficiency with electronic QMS software and collaborative platforms.

• Develop, implement, and monitor company-wide sanitation and hygiene programs.
• Conduct virtual audits and inspections of facilities to ensure compliance with standards.
• Analyze sanitation data and identify trends to recommend improvements.
• Develop and implement corrective action plans for non-compliance issues.
• Create and update sanitation protocols, procedures, and training materials.
• Provide remote guidance and support to site operations on sanitation best practices.
• Stay current with relevant regulations, industry standards, and best practices in sanitation.
• Collaborate with cross-functional teams to integrate sanitation requirements into operational processes.
• Manage sanitation documentation and record-keeping systems.
• Report on sanitation performance metrics and audit findings to management.

• Bachelor's degree in Microbiology, Environmental Health, Food Science, or a related field.
• Minimum of 6 years of experience in sanitation, quality assurance, or hygiene management.
• Demonstrated experience in developing and implementing sanitation programs.
• Strong knowledge of regulatory requirements (e.g., HACCP, GMP, OSHA).
• Excellent analytical and problem-solving skills.
• Proficiency in data analysis and report generation.
• Strong written and verbal communication skills for remote interaction.
• Ability to work independently and manage time effectively in a remote setting.
• Experience with virtual auditing tools and techniques.
• Familiarity with various industry-specific sanitation needs.