43 Qms Activities Jobs

As a Manager at Sun Pharma Laboratories Ltd in Guwahati - Operations OSD, your role will involve the following responsibilities: Role Overview: You will be responsible for monitoring and maintaining documentation related to QMS activities, including SOPs, change controls, deviations, and CAPAs. Additionally, you will handle market complaints by conducting root cause analysis and implementing corrective actions. Your role will also require ensuring implementation and compliance with Quality Management System (QMS) guidelines and facilitating training programs for personnel on QMS procedures, regulatory requirements, and best practices. Compliance with Good Manufacturing Practices (GMP) and co...

As a GLP-Quality Assurance Personnel at Syngene International Limited, Bengaluru, you will be responsible for ensuring alignment of laboratory practices with Good Laboratory Practice (GLP) guidelines to uphold the integrity and reliability of non-clinical safety and clinical studies. Your role will involve working in a regulatory environment to maintain compliance with national and international standards set by organizations such as OECD, FDA, ICH, and ISO. Key Responsibilities: - Ensure compliance with OECD principles of GLP, ICH, and WHO-GCLP - Handle inspections and audits - Manage QMS activities including change controls, deviations, and CAPA - Review SOPs, study plans, and documentatio...

As a QMS Project Reviewer at Syngene International Limited in Bengaluru, you will play a vital role in drug substance development and manufacturing processes. Syngene is an innovation-led contract research, development, and manufacturing organization that offers integrated scientific services from early discovery to commercial supply. Safety is a top priority at Syngene, and you will be expected to adhere to safety guidelines, procedures, and SOPs to ensure a safe working environment for yourself, your team, and the lab/plant. Key Responsibilities: - Following GMP, GDP, and GLP procedures - Creating/revising/reviewing procedures such as SOPs and protocols - Reviewing and approving Master BMR...

You will be responsible for the following key activities in the role of Asst Manager / Manager - Regulatory Affairs (Clinical Trials) for EU and US markets at USV Private Limited: Role Overview: You will be part of the Biologics function at USV Private Limited and will focus on Biosimilar Clinical Development Strategy, Clinical trials, injectables for EU and US markets. Key Responsibilities: - Develop Biosimilar Clinical design and Protocol for EU and US markets. - Manage Biosimilar Clinical Trial Application, including the overview of clinical study conduct and finalization of Clinical Study reports for EU and US markets. - Author and review Biologics/Biosimilar Dossiers, and handle eCTD su...

About Apotex Inc. Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions. For more information visit: www.apotex.com. Job Summary Responsible for allocation of work to the technicians in shifts and ensuring co...

About Apotex Inc. Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions. For more information visit: www.apotex.com. Job Summary Operation and Maintenance activities of utilities system, Installation, Modific...

Walk In Drive For Production Injectables In Formulation Division @ China Chilkamarri Department:- Production Injectables Qualification :-ITI | Diploma | BSC | B Pharmacy | B Tech Experience :- 2 To 8 Years Skills :- Aseptic area | QMS Activities | BMS & BPR review | Documentation | Filling | Validation protocol preparation | Vial washing | packing supervisor & Operator | Labelling | Filling | Compounding Division :- Formulation Interview Date:- 29-11-2025 Interview Time :- 9.00AM TO 2.00PM Work Location:- MSNF-II , Kothur , MSNF-V , China Chilkamarri Venue Location:- Unit-5 Chinna Chilkamarri, 25GX+XHX, Solipur, RK Puram, Telangana 509216 Note:- Candidate should bring Update Resume , Increme...

JD for Asst. Manager QA (Section Head : Validation and Qualification) Qualification : B Pharm/ M. Pharm Experience : 6 to 10 years. J ob Responsibilities Ensure compliance of all procedures, practices and system to cGMP with respect to Schedule M., WHO guidelines, Abbott Quality guideline and Standard operating procedures at site. Responsible for execution of Equipment and Instrument Qualification. Responsible for execution of Process validation and Cleaning validation. Should have knowledge of QMS activities. To perform acceptable quality level. Responsible for User management, Audit trail review of Production instruments. To deliver the training at site on GMP topics, SOPs and other techni...

You will be responsible for: - Handling QMS activities such as CCF, Deviations, and OOS - Preparing and reviewing SOPs, EOPs, OCPs, BMR, and production-related documents - Reviewing batch reports and participating in productivity improvements and batch failure investigations - Creating AIM and HIRA register - Conducting HAZOP study - Coordinating with QA for validation, qualification, and Audit preparedness - Ensuring adherence to Standard Operating Procedures and product specifications - Following Good Manufacturing Practices and Good Documentation Practices - Reviewing all completed documents for completeness and signatures - Performing data entry in Quality records Qualifications required...

Job description: To carry out routine Inspection on the final product and record in the register. To prepare, maintain and analyze line rejection and taking appropriate action to reduce To decide the line rejection and its disposal on weekly basis. To suggest the modification/improvement in the manufacturing process and fixtures. To carry out analysis of defects on daily / monthly basis, record and follow-up corrective actions. To submit basic data to Manager Quality at desired frequency and to get involved in problem analysis, recording, corrective actions and follow-up. To adhere all laid down quality systems To effectively participate in internal complaints corrective preventive actions. ...

As an ideal candidate for this role, you should come from an Auto components/Automotive industry background. You should have hands-on experience in Surface treatment, Machining, and Grinding. Additionally, you should possess hands-on experience in direct customer handling and good analytical knowledge. The factory is located in Bommasandra Industrial Area, Bangalore. Your responsibilities will include: - Being well versed with Quality systems/standards/QC Tools and handling of QMS activities - Ability to collaborate and lead a production team - Developing standardized production, quality, and customer-service standards - Identifying potential risks before they become a problem, focusing on r...

Role Overview: As a CSV - IT Executive at INFOTECH located in Gujarat, you will be responsible for performing various administration activities related to user management SOP. Your role will involve managing user access, privilege rights matrix, and application-wise process steps for user management. Additionally, you will be involved in handling IT-related QMS activities, backup and restoration tasks, and providing support during software assessment and network-related issues. You will also play a key role in ensuring compliance with regulatory requirements, conducting periodic verifications, and explaining IT roles to auditors and regulators. Key Responsibilities: - Perform all Administrat...

Experience : 7 to 12 years Responsible for qualification and re-qualification of lab equipment, instruments, utilities, and areas. Ensure preventive maintenance (PM), calibration, and breakdown support for all equipment. Prepare and manage calibration schedules; ensure timely execution and documentation. Handle SOP creation, revision, and training for equipment operation and maintenance. Support QMS activities including CCR, deviation handling, and documentation compliance. Manage equipment relocation and requalification under change control procedures. Coordinate with cross-functional teams for equipment procurement and installation. Raise and justify CAPEX/OPEX proposals; track budget util...

Date: 17 Oct 2025 Location: Bangalore, KA, IN, 560099 Division: Manufacturing Services Job Description Designation: Junior Manager Level: 8- I Job Location: Bangalore The Company Syngene International Ltd. (BSE: 539268, NSE: SYNGENE, ISIN: INE398R01022), is an integrated research, development, and manufacturing solutions company serving the global pharmaceutical, biotechnology, nutrition, animal health, consumer goods, and specialty chemical sectors. Syngene's 4500+ scientists offer both the skills and capacity to deliver great science, robust data management and IP security, and quality manufacturing at speed, to improve time-to-market and lower the cost of innovation. With a combination of...

About Apotex Inc. Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions. For more information visit: www.apotex.com . Job Summary The position entitles the incumbent to possess adequate practical and technica...

Job Title: Sr. Executive / Assistant Manager Quality Assurance, Pharma Educational Qualification B. Pharm / M. Pharm from a reputed university Experience 8 to 10 years of similar experience in a regulatory-approved OSD manufacturing large unit. Job Responsibilities & Accountabilities We are looking for an experienced QA professional to join our team and lead Deviation & Complaint Investigations, along with core QMS activities. Key Responsibilities Lead deviation and market complaint investigations, with timely CAPA execution Ensure effective implementation and tracking of CAPAs from deviations & complaints Review Batch Manufacturing & Packing Records, APQR, and SOPs Manage Change Controls, V...

Handling of QMS activities (CCF, Deviations and OOS etc.) Preparation and review of SOPs, EOPs, OCPs, BMR and production related documents. Review of batch reports and Involvements on productivity improvements and batch failure investigations. Preparation of AIM and HIRA register. Preparation of HAZOP study. To coordinate with QA for all the validation, qualification, and Audit preparedness. Adherence to Standard Operating Procedures, product specifications. Adherence to Good manufacturing Practices and Good Documentation Practices. Review All completed documents and ensuring that completeness and signed. Real time data entry in Quality records. Handling of e-BMR (SAP) activities. Sound know...

You will be working as an Asst Manager / Manager in the Biologics function of USV Private Limited in the Regulatory Affairs department specifically focusing on Clinical Trials for the EU and US markets. Your role will involve the following key responsibilities: - Developing Biosimilar Clinical Development Strategy, focusing on clinical trials and injectables for EU and US markets. - Designing and developing clinical protocols for Biosimilar Clinical trials, ensuring review and finalization for EU and US markets. - Handling Biosimilar Clinical Trial Applications, providing an overview of clinical study conduct, reviewing Clinical Study reports, and finalizing them for EU and US markets. - Aut...

Role Overview: As a GLP-Quality Assurance Personnel at Syngene International Limited, Bengaluru, you will play a crucial role in contributing to the GLP Quality Assurance Unit. Your primary responsibility will be to ensure compliance with OECD principles of Good Laboratory Practices (GLP), as well as ICH and WHO-GCLP guidelines. You will be tasked with handling inspections and audits, managing QMS activities such as change controls, deviations, and CAPA, and reviewing SOPs and study plans. Your core purpose in this role is to align laboratory practices with GLP guidelines to uphold the integrity and reliability of non-clinical safety and clinical studies. Furthermore, you will work in a regu...

As a QMS Project Reviewer at Syngene International Limited in Bengaluru, you will play a vital role in drug substance development and manufacturing processes. Syngene is an innovation-led contract research, development, and manufacturing organization that offers integrated scientific services from early discovery to commercial supply. Safety is a top priority at Syngene, and you will be expected to adhere to safety guidelines, procedures, and SOPs to ensure a safe working environment for yourself, your team, and the lab/plant. **Key Responsibilities:** - Following GMP, GDP, and GLP procedures - Creating, revising, and reviewing procedures such as SOPs and protocols - Reviewing and approving ...

As an experienced professional in the field of Quality Management Systems (QMS), you will be responsible for various key activities including handling of Corrective and Preventive Actions (CCF), Deviations, Out of Specification (OOS) incidents, and more. Your role will involve the preparation and thorough review of Standard Operating Procedures (SOPs), Equipment Operating Procedures (EOPs), Operational Control Plans (OCPs), Batch Manufacturing Records (BMR), and other crucial production documents. In addition, you will play a significant part in reviewing batch reports, identifying opportunities for productivity enhancements, and conducting investigations into batch failures. Your expertise ...

Date: 1 Sept 2025 Location: Bangalore, KA, IN, 560099 Custom Field 1: Development Services Job Title: Analyst Job Description At Syngene, Safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures, and sops, in letter and spirit Mandatory expectation for all roles as per Syngene safety guidelines Overall adherence to safe practices and procedures of oneself and the teams aligned Contributing to development of procedures, practices and systems that ensures safe operations and compliance to companys integrity & quality standa...

You should have 14 years of experience in the pharmaceutical industry with a focus on Microbiology. Your responsibilities will include MLT testing, validations, equipment qualifications, document preparation, initiation and closing of change control, OOS, OOT's, lab maintenance with GMP norms and GLP. You will be involved in QMS activities, trends preparation, and overall lab maintenance while coordinating with colleagues. Additionally, proficiency in Data kart software for dispatching finished products is required.,

You are invited to join Zydus LifeSciences Ltd. at their Injectable manufacturing plant in Ahmedabad. We are currently looking to fill the following positions: 1. Production: - Staff positions ranging from Executive to Assistant Manager require candidates with a B. Pharm / M. Pharm/ B.E background and 4 to 10 years of experience in Supervising and Controlling Production areas such as Isolator, Aseptic Filling, Vial Washing, Autoclave, Lyophilizer, and Visual Inspection. Knowledge of QMS activities is a plus. - Plant Operator and Technical Assistant roles require candidates with a Diploma or ITI qualification and 3 to 6 years of relevant experience in operating production machines like Isolat...

The ideal candidate for this position should have a background in Auto components / Automotive industry. You should have hands-on experience in Surface treatment, Machining, and Grinding. Additionally, you must possess direct customer handling skills and good analytical knowledge. The factory is located in Bommasandra Industrial Area, Bangalore. Your responsibilities will include being well-versed in Quality systems, standards, and QC Tools. You should have experience in handling QMS activities and be able to collaborate and lead a production team. Your role will involve developing standardized production, quality, and customer-service standards. You will need to identify potential risks pro...