27 Qms Activities Jobs

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...

As a candidate for this role, you will be responsible for handling various Quality Management System (QMS) activities such as managing Corrective and Preventive Actions (CCF), deviations, and Out of Specification (OOS) incidents. Your duties will include preparing and reviewing Standard Operating Procedures (SOPs), Equipment Operating Procedures (EOPs), Operating Control Plans (OCPs), Batch Manufacturing Records (BMR), and other production-related documents. Additionally, you will be required to review batch reports, participate in productivity improvement initiatives, and investigate batch failures. You will also be responsible for creating and maintaining the Asset Integrity Management (AI...

As a Senior Manager Production at our Guwahati location, you will be responsible for overseeing all manufacturing operations to ensure smooth production processes and meeting quality standards. Your role involves planning, coordinating, and directing production activities while ensuring compliance with safety, regulatory, and company policies. Your key responsibilities will include planning and coordinating production and packing activities to achieve monthly targets. You will review daily production activities for various processes such as Granulation, Compression, Coating, Capsule filling, Inspection, Packing, and Nutra section. Ensuring Good Documentation Practices (GDP) at the shop floor...

As an Executive/Sr. Executive in the Engineering department at Liva Pharma's plant, you will be responsible for various tasks related to equipment maintenance and compliance procedures. Your key responsibilities will include: - Reviewing the plant equipment logbook and ensuring its accuracy. - Preparation and implementation of Standard Operating Procedures (SOPs) to maintain operational standards. - Ensuring compliance with relevant SOPs and performing necessary Preventive Maintenance (PM) and calibration before due dates. - Implementing corrective and preventive actions as required. - Recording and maintaining plant equipment maintenance activities. - Conducting training sessions for subord...

Handling of Change Management, Deviations, Out of Trend, Out of Specification and CAPA closure of the same before the product release. Handling of QMS activities in Track Wise system and documents through SAP system, as applicable. Track and complete all the QMS activities within the due date. Coordinating for complaint investigation, handling of Return Goods and Recall. Review of contract manufacturing / testing documents such as, executed BPR and Analytical reports. Shall be responsible for performing unplanned audit on shop floor. Monitoring of Manufacturing Process to identify the root cause for product failure and cleaning incident. Shall be responsible for review and closure of Change ...

As a Quality Assurance Specialist, your primary responsibility will be to handle Change Management, Deviations, Out of Trend, Out of Specification, and CAPA closure before the product release. This includes coordinating QMS activities in the Track Wise system and managing documents through the SAP system. It is essential to track and complete all QMS activities within the specified due date. You will be tasked with coordinating complaint investigations, managing Return Goods, and handling Recalls. Additionally, reviewing contract manufacturing and testing documents such as executed BPR and Analytical reports will be part of your duties. Your role will involve performing unplanned audits on t...

Date: 2 Aug 2025 Location: Bangalore, KA, IN, 560099 Custom Field 1: Essential Functions Job Description Job Title: GLP-Quality Assurance Personal Job Location: Syngene International Limited, Bengaluru About Syngene : Syngene ( www.syngeneintl.com ) is an innovation-led contract research, development and manufacturing organization offering integrated scientific services from early discovery to commercial supply. 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 ...

About Apotex Inc. Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 7,200 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 75 countries globally. Through vertical integration, the Apotex group is focused on the development and sale of generic, biosimilar and specialty products. For more information visit: www.apotex.com. Job Summary Responsible for allocation of work to the technicians in shifts and ensuring completion of activity. Ensuring /Performing PM activities of Process equipments within the specified limit...

About Apotex Inc. Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 7,200 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 75 countries globally. Through vertical integration, the Apotex group is focused on the development and sale of generic, biosimilar and specialty products. For more information visit: www.apotex.com . Job Summary Responsible for allocation of work to the technicians in shifts and ensuring completion of activity. Ensuring /Performing PM activities of Process equipments within the specified limi...

You will be responsible for managing all Quality Management System (QMS) activities related to production. It is crucial to ensure that batch charging and other manufacturing operations strictly adhere to the Batch Manufacturing Record (BMR) and Standard Operating Procedures (SOP), aligning with current Good Manufacturing Practices (GMP). Your duties will include maintaining manufacturing records online, collecting samples of intermediate materials, entering production-related data into the SAP system, and verifying the generation of PISCADA reports. Additionally, you will be tasked with overseeing finished goods transfer, monitoring stock levels of consumables, coordinating with various ser...

You are invited to attend a walk-in interview for Zydus Animal Health Unit in Ahmedabad on 03rd August 2025 at Hotel Woodlands, NH 8, Near Tejpal Motors, Balitha, Vapi, Gujarat 396191. The interview timings are from 9:00 AM to 04:00 PM. The job location is Pharmez Matoda, Ahmedabad. In the Manufacturing (OSD) Department, we are looking for candidates for the following roles: 1. Officer/Executive: - Qualification: B. Pharma/M. Pharma - Experience: 2 - 7 years - Responsibilities: - Planning manufacturing batches in coordination with PPMC - Monitoring line clearance, cleaning of equipment, and instruments - Performing qualification activities - Initiating QMS activities such as change control, ...

Date: 2 Jul 2025 Location: Bangalore, KA, IN, 560099 Custom Field 1: Essential Functions Job Description Job Title: QMS Project Reviewer Job Location: Syngene International Limited, Bengaluru About Syngene : Syngene (www.syngeneintl.com) is an innovation-led contract research, development and manufacturing organization offering integrated scientific services from early discovery to commercial supply. 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 f...

Job Description: 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. Your core responsibilities will include following GMP, GDP, and GLP procedures, creating/revising/reviewing procedures such as SOPs and protocols, rev...

Job Title: GLP-Quality Assurance Personnel Location: Bangalore, KA, IN, 560099 Syngene International Limited, Bengaluru is an innovation-led contract research, development, and manufacturing organization offering integrated scientific services from early discovery to commercial supply. At Syngene, safety is a top priority, with a focus on ensuring safety guidelines, procedures, and SOPs are followed diligently. As a GLP-Quality Assurance Personnel at Syngene, you will play a crucial role in aligning laboratory practices with Good Laboratory Practice (GLP) guidelines to maintain the integrity and reliability of non-clinical safety and clinical studies. You will also work in a regulatory envir...

You will be joining USV Private Limited, a leading pharmaceutical company in India known for its expertise in the diabetes and cardio sectors, with a global presence in over 65 countries. Your role will be in the Biologics function, specifically as an Assistant Manager or Manager in Regulatory Affairs (Clinical Trials) focusing on the EU and US markets. You will be based in Govandi (East), Mumbai, with a work schedule that includes working on the 1st, 3rd, and 5th Saturdays, while having the 2nd and 4th Saturdays off. To be considered for this position, you should have a qualification of M.Pharm/B.Pharm along with 5-15 years of relevant work experience in Regulatory Affairs-Clinical Trials f...

Role & responsibilities Position: Executive/Sr.Executive-Mechanical -Installation & Commissioning 1No Qualification: B.E/Diploma in Mechanical with 3 to 4 Years exp. 1. At least 3 years handling Experience on Bio-pharmaceutical Projects / Maintenance / Operations or in Project Consulting firms. 2. Hands on Experience on Execution of Equipment Installation & Commissioning Activities 3. Hands on Experience on Clean & Black Utility systems installation, commissioning & Qualification 4. Experience in process drain piping, external pipe rack systems installation & commissioning. 5. Responsible for construction quality and commissioning readiness of various utility systems. 6. Preparation, Review ...

Prepare trending of Events/Incident and ensure completeness of its closure. Identify the gaps and provide appropriate training to analytical scientist to strengthen compliance level. Thorough review of clinical batch release data, method validation protocol & report, clinical stability sample analysis, as per cGMP and regulatory requirement. Ensure review of daily verification/calibration of pH meter, balances and TOC. Ensure review of calibration record of all analytical instruments and update of calibration planner in timely manner. Thorough review of method development report and investigation study report Randomly review and cross verify all analytical instrument logbook entries and labo...