20 Capas Jobs

The role of QMS Manager (Pharmacovigilance (PV)/GCP Auditing) based in Chandigarh, India requires you to perform various Quality Assurance activities either independently or in collaboration with the Quality Head. Your responsibilities include managing quality issues, events, deviations, and CAPAs, as well as conducting Root Cause Analyses (RCAs) or guiding staff in performing them. You will also be involved in developing CAPA plans and ensuring their implementation, planning audits based on risk assessment, and maintaining the audit planner in compliance with GVP and GCP requirements. Additionally, you will be responsible for preparing audit schedules, conducting internal audits and vendor ...

This is where your work makes a difference. At Baxter, we believe every person-regardless of who they are or where they are from-deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. ...

This is where your work makes a difference. At Baxter, we believe every person-regardless of who they are or where they are from-deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. ...

We are seeking a meticulous AQA - Data Reviewer to conduct quality reviews of key pharmaceutical documents and ensure compliance with regulatory standards, including 21 CFR. The ideal candidate will collaborate with cross-functional teams to maintain document integrity and support continuous quality improvement. Key Responsibilities: Conduct thorough quality reviews of documents such as CAPAs (Corrective and Preventive Actions), change controls, and ensure compliance with 21 CFR regulations. Ensure adherence to company policies and standard operating procedures through detailed document reviews. Develop and maintain a comprehensive understanding of pharmaceutical regulatory requirements. Pro...

You will be part of the Documentation team in the Production Department at Sai Life Sciences located in Bidar. As a leading Contract Research, Development, and Manufacturing Organization (CRDMO), we partner with numerous global innovator pharma and biotech companies to support the advancement of their NCE programs. With a workforce of over 3000 professionals in India, the UK, and the USA, we are dedicated to fostering scientific excellence and ensuring customer success. Our organization is characterized by a culture of openness, mutual respect, and inclusivity, and we are committed to diversity and equal opportunity practices at all levels. Your primary responsibilities will include drafting...

As the Head of Global Quality at our company based in Navi Mumbai, India, you will play a crucial role in leading the development and execution of quality assurance strategies that align with our long-term goals. Partnering closely with the Chief Technical Officer (CTO) and the Leadership Team, you will ensure the implementation of robust quality management systems, regulatory compliance, and a continuous improvement in operational performance. Your responsibilities will include establishing best-in-class quality goals, performing quality metrics trending, and implementing problem-solving and system improvements to meet target levels of quality. You will lead and manage the quality teams acr...

Regeneron is founded on the belief that the right idea, combined with the right team, can lead to significant transformations. Our growing global network is dedicated to inventing, developing, and commercializing medicines that change lives for those with serious diseases. In doing so, we are pioneering innovative approaches to science, manufacturing, and commercialization, as well as redefining our understanding of health. We are looking for a motivated individual to support cGMP compliance within procurement operations. In this role, you will assist with key compliance activities such as investigating deviations, supporting CAPAs, coordinating supplier audits, handling change controls, and...

The ideal candidate will be responsible for leading end-to-end upstream fermentation operations, which includes tasks such as media preparation, seed culture development, fermentation scale-up, and harvest. You will be required to optimize classical microbial fermentation processes to achieve high cell density and metabolite production using various microorganisms like bacteria, yeast, or fungi such as E. coli, Bacillus, Saccharomyces, and Streptomyces. It will be your duty to ensure that production targets in terms of volume, yield, quality, and timelines are consistently met. In cases of upstream process deviations, contamination, or yield drops, you will be expected to troubleshoot effect...

As a Quality Control Technician III at TAPI, you will be an integral part of the leading international supplier of active pharmaceutical ingredients (APIs). TAPI boasts the industry's broadest portfolio, which includes over 350 API products. With a rich history spanning over 80 years, we are recognized as one of the most trusted API suppliers globally, catering to 80 PERCENT of the top 50 pharmaceutical companies. At TAPI, our commitment to excellence is driven by our experience, expertise, cutting-edge technologies, and unwavering dedication to exceptional customer service. Your primary responsibilities will include maintaining 24/7 audit readiness, possessing expertise in Wet Chemistry, an...

Job Description Summary You will be delivering traceability, flow down of requirements to team, system design and analysis, requirements definition, Risk files, and Verification and Validation test procedures for NPI and install base (IB) products Owning & delivering the product investigations/CAPA/NC GE Healthcare is a leading global medical technology and digital solutions innovator Our mission is to improve lives in the moments that matter Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world, GE HealthCare is a leading global medical technology and digital solutions inno...

As the Head of Corporate Quality in the Global Supply Organization at our base location in Navi Mumbai, India, you will play a crucial role in leading the development and execution of quality assurance strategies that are in line with our company's long-term objectives. Working closely with the Chief Technology Officer and the GSO Leadership Team, you will be responsible for ensuring the implementation of robust quality management systems, regulatory compliance, and driving continuous improvement in operational performance. Your responsibilities will include establishing best-in-class quality goals, analyzing quality metrics trends, implementing problem-solving strategies and system enhancem...

As a quality control professional, you will be expected to strictly adhere to cGMP norms and safety rules within the factory premises. Your key responsibilities will include verifying logbooks, records, and other analytical documents on a daily basis to ensure their correctness and completeness. It will be your duty to ensure the timely preparation and revision of SOPs, STPs, and other Quality Management System (QMS) documents. You will also be responsible for the prompt completion of investigation activities related to Quality Control (QC) aspects such as Out-of-Specification (OOS), Out-of-Trend (OOT), deviations, and out-of-compliance (OOC) activities. Moreover, you will be accountable for...

The role of Quality Control Manager in Critical Care Business at Bethlehem, PA involves overseeing all Quality Control functions to ensure alignment with core values and ethical practices. Your primary responsibility is to ensure that the Quality Control department meets the needs of both internal and external customers by delivering services and products on time. You will collaborate with various internal stakeholders such as API Manufacturing, Packaging, Quality Assurance, Engineering, Regulatory Affairs, EHS, Supply Chain and Logistics, as well as external stakeholders including Auditors, Customers, Regulatory Agencies, and External Suppliers. Reporting directly to the Senior Manager of Q...

The Quality Assurance (QA) Executive API (Bulk Drugs) role based in Savli, Gujarat requires a candidate with 2-5 years of experience and a qualification of B.Sc / M.Sc. As a QA Executive, your responsibilities will involve ensuring compliance with cGMP, ICH, and regulatory guidelines in API (bulk drug) manufacturing. You will be responsible for preparing, reviewing, and controlling SOPs, BMRs, BPRs, change controls, deviations, and CAPAs. In addition, conducting in-process checks for manufacturing and packaging activities, handling investigations for deviations, OOS/OOT results, and supporting root cause analysis are key components of this role. You will also be involved in participating in ...

As a Security leader with a background in AWS and cloud Security, you play a crucial role in defining and enforcing the security policies and procedures of the organization. With excellent written and verbal communication skills, exceptional organizational abilities, and expert-level proficiency in IT and Cloud Security, you will be responsible for architecting and implementing IT Security policies while reporting to the Director of Information Technology. In this full-time role, your essential duties and responsibilities include providing leadership and technology vision to the IT Security team, performing internal and external security audits, documenting, implementing, and monitoring adhe...

Oversee all QA activities related to API manufacturing in line with cGMP and regulatory standards. Review and approve manufacturing and analytical documents including MBMRs, BPRs, validation protocols and reports.

Ensure compliance with cGMP, ICH, and regulatory guidelines in API manufacturing Review and approval of master batch manufacturing records (MBMR) and batch packing records (BPR).

Regulatory Strategy & Compliance – US FDA, EU MDR, CDSCO Documentation & Regulatory Submissions Regulatory Monitoring & Reporting UDI Submission – GUDID / EUDAMED Regulatory Audits, Inspections, CAPAs & NCs Closure Required Candidate profile BE/BTech in Mechanical, Biomedical, Biotech, or related fields Min 2 years of exp. in RA for medical devices Knowledge of U.S. FDA, EU MDR, CDSCO regulations RAC/GATE certification is a plus

Job title manager GMP (Good Manufacturing Practices) QA (Quality Assurance) Reports to Head of Quality Assurance (GMP and GCP) Job purpose Our Quality team is growing, and we are currently seeking a Manager of GMP QA Operations to play a pivotal role in ensuring the quality and compliance of our clinical and commercial manufacturing processes. Reporting to the Head of QA, the Manager will oversee a team responsible for manufacturing, batch record release, investigations, deviations, CAPAs (Corrective and Preventive Actions), change controls, analytical methods, stability programs, and auditing within our GMP operations. Duties and responsibilities QA managers define and implement quality sta...

Role & responsibilities IMS Documentation & Control Audit Planning and Execution Certification Bodies Liaison Non-Conformities and CAPAs Management Review Meetings Risk Assessments Training and Awareness Regulatory Compliance Preferred candidate profile Education: Bachelor's degree in Engineering , Environmental Science , Health & Safety , or a similar field. Experience: 3 to 7 years in IMS coordination , Quality Systems , or HSE (Health, Safety, Environment) . Audit Experience: Proven experience in both internal and external audits . Certifications: ISO Internal Auditor certification (9001, 14001, 45001) is preferred. Tools Knowledge: Should know how to use document control systems and audi...