37 Capas Jobs

Job Description JOB Responsibilities: - Location: Ahmedabad 1. Ensuring the GMP compliance at CMO and Release of batch manufactured for US market at CMU. 2. Monitoring of process starting from dispensing to packing including witness analysis of Lupin products manufactured at CMO for US market and Domestic market. 3. Handling of market complaint with root cause identification and ensuring the CAPA implementation. 4. New product review to be carried out at manufacturing site after availability of all the documents. 5. Review and authorize Master Batch Records, stability protocol, process validation protocol, temperature cycling protocol, specification of in-process, intermediate and finished p...

Tips: Provide a summary of the role, what success in the position looks like, and how this role fits into the organization overall. Responsibilities Participate in the implementation and maintenance of the management system compliance with relevant international quality standards and regulatory requirements (Such as ISO 13485, ISO 14971, MDR 2017/745, and 21 CFR part 820). Participate in development of Regulatory Strategy for upcoming products against GSPR requirements. Participate in the development of QA strategies, recommendations for Continual improvement, Quality planning in conjunction with the needs of the company, for each product range and Quality Management System. Sustain and acti...

Role & responsibilities : Ensure full cGMP and safety compliance in warehouse operations Periodic review and update of SOPs within defined timelines Conduct training sessions for warehouse personnel as per schedule Oversee FIFO-based material issuance to user departments Maintain accurate GMP documentation and ensure Bin Card posting Monitor re-test, non-moving, and rejected materials Ensure effective housekeeping and clean storage conditions Develop and implement SOPs for all warehouse activities Assign and monitor individual responsibilities of warehouse staff Ensure equipment calibrations as per schedule Supervise daily operations: inventory, QA, logistics, dispatch, and customer service ...

Role Overview: As the Key & Operational Lead for upstream fermentation operations, your role will involve overseeing end-to-end upstream fermentation operations, including media preparation, seed culture development, fermentation scale-up, and harvest. You will be optimizing classical microbial fermentation processes for high cell density and metabolite production using various microorganisms such as bacteria, yeast, or fungi (e.g., E. coli, Bacillus, Saccharomyces, Streptomyces). It will be your responsibility to ensure consistent achievement of production targets in terms of volume, yield, quality, and timelines. Additionally, you will troubleshoot upstream process deviations, contaminatio...

As a QA Officer specializing in Oral Solid Dosage (OSD) pharmaceutical manufacturing at [Company Name], your role will be crucial in ensuring compliance with regulatory standards, maintaining quality systems, and overseeing manufacturing processes to uphold consistent product quality. Key Responsibilities: - Implement and monitor adherence to GMP and SOPs for OSD manufacturing. - Conduct in-process quality checks for tablets, capsules, and other forms. - Review and approve batch manufacturing records and validation protocols. - Assist in internal and external audits, including regulatory inspections. - Provide training to production staff on quality and compliance standards. - Participate in...

As a Research and Development Operator I at our company, your role will involve operating, cleaning, disassembling, and reassembling equipment such as blending, granulation, compression, and coating machinery in accordance with applicable cGMPs and SOPs. You will rotate between the Pilot Plant and Manufacturing departments based on business needs. This position is safety-sensitive. **Key Responsibilities:** - Proficiently operate, disassemble, assemble, and clean equipment. - Perform housekeeping tasks to maintain cleanliness and routine maintenance of the work area and equipment. - Utilize computer systems to read, review, and train on SOPs. - Review current SOPs and suggest process improve...

As a Deputy Manager/Manager Level1 (Production) at Polypeptide Group, you will be responsible for managing daily production operations, ensuring compliance with GMP standards, and coordinating with various teams to meet production targets. Your expertise in the Peptide Industry, particularly in solid phase peptide synthesis, purification, and lyophilization, will be essential for maintaining a high level of productivity and quality. Key Responsibilities: - Oversee daily production activities and planning to meet monthly, quarterly, and yearly targets. - Manage inventory to maintain optimal stock levels. - Prepare MBPRs, SOPs, and risk assessment documents. - Investigate deviations, identify ...

As a Technical Lead for Device Customer Support at Landis+Gyr, your role involves managing all aspects of support and maintenance for Landis + Gyr Electricity Devices within the EMEA region. This includes handling quality cases, CAPAs, and acting as the interface to Quality and local technical support organizations. Your responsibility also includes maintaining the KPIs assigned by Business Units Electricity and collaborating with Sales, Product Management, and Operations teams to prioritize case work. You will be working closely with global teams to promote and develop process development and continuous improvement, as well as providing global technical tender support for customer projects....

Position title: ESO QA Specialist University degree in Pharmacy, Chemistry, Biology, or relevant Life Science Minimum of 5 years in a similar role or equivalent experience in a GMP-related environment Job location - Ankleshwar, Gujarat, India MISSION STATEMENT To ensure the quality lifecycle management for dedicated, subcontracted, product portfolio. Qualified auditor. Main Accountabilities And Duties Operational skills Operational quality management of a dedicated product portfolio which includes: Quality management of deviation and complaint records and their related CAPAs Assessment and management of change controls Edition of QA Agreements with Zentiva third parties and subcontractors Co...

Role : SRE Engineer (Site Reliability Engineer) Location : Marathali Bangalore. Work Mode : Hybrid Mode (Weekly 3 days) Exp : 6 – 10 Years Required Candidate profile Skills : Python, AWS (EC2, IAM, Lambda, API Gateway, SNS, SQS & etc.), GITHUB Actions, Service Management, Incident Management etc. & CAPAs. Share resume on Atiya@infogrowth.in or 8341524054

Role : SRE Engineer (Site Reliability Engineer) Location : Marathali Bangalore. Work Mode : Hybrid Mode (Weekly 3 days) Exp : 6 – 10 Years Required Candidate profile Skills : Python, AWS (EC2, IAM, Lambda, API Gateway, SNS, SQS & etc.), GITHUB Actions, Service Management, Incident Management etc. & CAPAs. Share resume on Atiya@infogrowth.in or 8341524054

In this role at Piramal Agastya, your primary responsibility is to ensure compliance with regulatory and Pharmacopoeial standards through compendia assessments, Quality Management System (QMS) oversight, and documentation preparation. You will collaborate with global sites, vendors, and internal teams to develop quality agreements and provide support during audits and inspections. Additionally, you will be managing SOPs, monitoring QMS events, and preparing essential quality documentation and reports. As part of your responsibilities, you will: - Conduct compendia assessments for all materials used on-site to identify gaps against current Pharmacopoeial requirements and implement risk mitiga...

As an administrator in this role, you will be responsible for managing document system access and revision control to ensure appropriate security based on business needs. You will also assist in assessing, acquiring, and deploying electronic document management systems. Additionally, you will play a key role in developing document classifications to facilitate information storage and retrieval. Your key responsibilities will include: - Assisting managers and others in creating training curricula, materials, and documentation - Providing additional support to the Quality organization, which includes maintaining original Quality documents, loading PDFs into the Quality SharePoint, and updating...

1. Understanding of various SDLC methodologies (Agile, Waterfall, V) 2. Experience in Programming or scripting languages (Java/JS etc.,). 3. Experience in designing automation frameworks (POM, Cucumber BDD, etc.,). 4. Generate Automation Test Strategy for applications deployed on Cloud. (Public and Private cloud) 5. Automate scripts using a given Selenium-based framework, Serenity based BDD framework or any open-source tools. 6. Working experience in testing Restful Webservices and APIs using frameworks or tools like POSTMAN, Rest API, etc. 7. Good experience with VAPT. 8. Knowledge of Performance testing using Jmeter or any open-source tools. 9. Perform Risk Analysis of Project & automation...

Responsibilities: * Manage quality control processes from raw materials to finished products. * Conduct regular inspections using Capas, 5S system & ISO documentation. * Ensure compliance with fabrication drawing standards. Office cab/shuttle Food allowance Annual bonus Provident fund

As an Engineering Stores - Executive at Teva Pharmaceuticals, you will play a crucial role in ensuring the smooth functioning of the engineering department. Your responsibilities will include the following: - Overall management of engineering activities, including monitoring and review of procedures and cGMP records in the engineering store to ensure compliance. - Preparation and review of Engineering store SOPs in Glorya Electronic Data Management System. - Ensuring readiness of the department for regulatory inspections and compliance with regulations. - Upkeeping of engineering store compliance and initiation/execution of Change Controls, Deviations, Investigations, CAPAs in Trackwise Syst...

-- Handle QMS activities: Change Controls, Deviations, CAPAs, and Event Investigations (TrackWise) , - Review and prepare GMP documents (SOPs, BMRs, BPRs). -Conduct training programs on cGMP and SOPs as per TNI or schedule. Troubleshoot production issues to prevent downtime. -Ensure compliance with regulatory standards and internal SOPs. - Maintain accurate documentation: batch records, equipment logs, quality reports. Hands-on with equipment: autoclaves, DHS, PFS filling machines, mixing vessels, packing lines. -Familiar with utilities: DG sets, HT Panels, Transformers. - 8+years of experience in OSD/API manufacturing.

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...