316 Gmp Compliance Jobs - Page 7

Foreman Injectables 1 Post based in Amritsar The ideal candidate brings 5-6 yrs exp and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Lean/Kaizen) Operate and tro...

Senior Executive QA 1 Post based in Kathua, Jammu & Kashmir The ideal candidate brings 8-10 Years and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Lean/Kaizen) S...

Senior Officer QA 3 Posts based in Kathua, Jammu & Kashmir. The ideal candidate brings 4-6 yrs exp and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments. Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety. The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Lean/Kaizen...

Senior Officer QA (QMS) 1 Post based in Kathua, Jammu & Kashmir. The ideal candidate brings 4 - 6 yrs exp and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments. Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety. The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Lean...

Job Description Manager / Sr. Manager (Contract Manufacturing & Quality Compliance) Location: Pune Department: Manufacturing & Quality Reports To: Head – Operations / Quality Role Overview We are seeking an experienced and proactive professional to manage and coordinate production activities at contract manufacturing sites. The ideal candidate will have strong expertise in production planning, quality systems, regulatory compliance, and cross-functional collaboration to ensure timely supply of high-quality products in alignment with business objectives and global regulatory expectations. Key Responsibilities Production & Planning Manage and oversee production planning at contract manufacturi...

As a Mechanical Technician in the Food Industry based in the Kingdom of Saudi Arabia (KSA), you will play a crucial role in supporting the operation, maintenance, and repair of mechanical equipment used in food processing and packaging plants. Your responsibilities will include performing routine preventive and corrective maintenance on a variety of food processing and packaging machinery, troubleshooting mechanical faults, and ensuring compliance with hygiene and food safety standards. Additionally, you will be involved in equipment installation, alignment, calibration, and mechanical testing to ensure efficient and safe operations. You should have a Diploma in Mechanical Engineering or a r...

As a MES Consultant or Recipe Author, you should have experience in Rockwell PharmaSuite MES and a solid understanding of pharmaceutical manufacturing processes, particularly in solid oral dose and packaging. Your skills should encompass EBR design and configuration, validation documentation, and ensuring GMP compliance. Proficiency in tools such as Microsoft Visio, Rockwell PharmaSuite, and any legacy EBR tools like P2C2 and PMX is essential for this role. Having experience in working with Italian clients would be a bonus, especially if you possess Italian language proficiency. The preferred start date for this position is July 1, 2025. The job locations available for this role are in India...

Role & responsibilities 1) Should be qualified M. Pharmacy, expertise in Pharmaceutical Analysis and Quality Assurance, Pharmaceutics, Industrial Pharmacy 2) Basic awareness of GMP & GLP as per regulations Preferred candidate profile 1) Having good communication skills 2) Having basic analytical knowledge

As an operator in our team, your primary responsibility will be to operate herbal extraction equipment such as Extractor reactors, filtration units, evaporators, and other associated machinery. You will diligently follow batch processing instructions and Standard Operating Procedures (SOPs) to ensure efficient and accurate production processes. In addition to operating the equipment, you will be responsible for maintaining detailed batch records, Batch Manufacturing Records (BMR), logbooks, and ensuring compliance with Good Manufacturing Practices (GMP). Your role will also involve conducting in-process checks on parameters such as temperature, pH levels, moisture content, and other relevant...

You should have 3-5 years of hands-on experience in Granulation, Compression, and Coating processes. Additionally, you must possess good machine handling skills including RMG, FBD, Compression, and Coating equipment. Your responsibilities will include monitoring and supervising operations, ensuring online documentation, and maintaining compliance with SOP and GMP regulations. It is essential to have knowledge of SOP, BMR, and BPR preparation and review. Manpower handling skills and experience in production planning and execution are crucial for this role. Familiarity with Pharma Cloud software is required. This is a full-time position with benefits such as Provident Fund and a yearly bonus. ...

Role & responsibilities Lead and manage the stability study program as per ICH guidelines. Plan, initiate, and monitor real-time, accelerated, and intermediate stability studies for all products. Ensure timely sampling, testing, and data review for all ongoing stability studies. Maintain and review stability protocols and reports, ensuring compliance with regulatory requirements. Handle stability chambers (qualification, calibration, and monitoring) and ensure 21 CFR Part 11 compliance. Provide managerial oversight for instrument calibration, qualification, and maintenance activities in QC lab. Ensure timely availability of reagents, reference standards, working standards, and lab consumable...

Specific Responsibility, but not limit to : To review and approval of all concerned department master SOPs / GTP / BMR / Spec. & STP of Finished Products, Raw Materials & Packing Materials and its compliance in the System. Implementation and compliance of approved SOPs in the system To ensure quality system are maintain as per ISO requirements and followed by GMP guidelines. To investigate the route cause for Out of specification analytical reports. To handle the market complaint and investigate to find out route cause and in coordination with concerned departments and communicate to management and customer. To review all critical Deviation are investigated and resolved. Review and approval ...

Responsibilities Batch Record Management : Quality Documentation : Compliance & Preventative Maintenance : Operations Support :

Maintaining Quality Systems Ensuring cGMP compliance Prepare Batch Manufacturing Records Process Validation and Cleaning Validation Dossier Preparation and New Drug Applications Document Quality Risk activities Required Candidate profile Experience in GMP, ICH Q series and pharmaceutical quality systems Strong in documentation, audit preparedness and regulatory compliance

The ideal candidate will be responsible for overseeing the execution of production plans by utilizing pre-approved procedures, protocols, and manufacturing records. You will need to ensure strict adherence to cGMP and EHS (Environmental, Health, and Safety) norms to maintain compliance. Additionally, you will supervise and coordinate production activities, managing available resources effectively to meet production targets. Maintaining quality control is a key aspect of this role, where you will be required to uphold standard process parameters following Batch Manufacturing Records (BMRs) and other relevant documents to ensure high-quality production and compliance. Furthermore, you will be ...

As a Quality Assurance Specialist, you will be responsible for reviewing paper and electronic batch records to ensure completeness, clarity, and compliance with Good Manufacturing Practices (GMP). Your role will involve assessing the documentation related to raw materials and releasing them for production. You will provide quality support by contributing to the development of Corrective and Preventative Actions (CAPAs) and offering guidance to various departments on GMP aspects. Additionally, you will review and approve quality assurance controlled documents such as Standard Operating Procedures (SOPs), batch records, and work instructions. In this position, you will be tasked with evaluatin...

As an Executive/Senior Executive in the R&D Quality-CMC QA department at Sun Pharmaceutical Industries Limited in Gurugram, your primary responsibility will include reviewing various R&D documents such as stability data, analytical reports, method qualification reports, method verification reports, method validation protocols & reports, working standard/impurity standard profile, analytical data of pilot bio batches, and method transfers protocol & report. You will also be required to review lab events, deviations, change control, CAPA, and associated investigation reports before Technology Transfer. Additionally, you will support and participate in failure investigations to resolve root cau...

Position : Executive Engineering QMS Qualification : BE Mechanical/ Electrical/ Instrumentation or B pharma preferably BE Experience : 6-7 years experience in handling engineering department GMP documentation activities and supporting engineering function as SME in QMS documentation Responsibilities : 1.Implementation of quality assurance standards, processes, controls and cGMP in warehouse. 2. Preparation of SOPs and ensure effective implementation. 3. should be well versed with deviation management SOP 4. Should be well versed with change control and CAPA management related to engineering department 5. Should be familiar with documentation like DQ, IQ, OQ and PQ. 6. To ensure that training...

Key Responsibilities Execute daily production operations as per approved SOPs, BMR/BPR, and production plan. Handle manufacturing processes, equipment operations, cleaning, and changeover activities. Prepare, review, and maintain production documentation (BMR, BPR, logbooks, and SOPs). Ensure adherence to cGMP, GDP, and EHS standards across production processes. Actively participate in QMS activities deviations, CAPA, change controls, incident handling. Coordinate with QA, QC, Engineering, and Warehouse for smooth batch execution. Assist in audit preparation (internal, regulatory, and customer audits) with proper documentation. Monitor yield, productivity, and process improvements to minimiz...

Role Objective/Purpose of the Role The position has overall responsibility for HVAC services of manufacturing plant. The focus of the role is to perform the sites HVAC operation, maintenance with its ancillaries including BMS HVAC control systems, cooling tower, chiller, DHU, etc, and covering engineering maintenance on site, capital projects related to his/her area of work, and compliance with regulatory standards. This role will be reporting to Engineer BMS & HVAC System. Only ITI/Diploma candidate preferred, Strictly no BE Primary Responsibilities: Operate, Inspect, Maintain and troubleshoot chillers, cooling towers, water treatment systems, pumps, AHU, DHU, dust collectors, ventilation s...

Key Responsibilities: Prepare, review, and maintain Batch Manufacturing Records (BMR) / Batch Packing Records (BPR). Ensure compliance with QMS activities Deviations, Change Controls, CAPA, and Incident handling. Draft, review, and implement SOPs in alignment with regulatory and cGMP requirements. Maintain production-related documentation in compliance with audit and regulatory standards. Coordinate with QA, QC, and other departments for documentation and compliance activities. Support in production planning, line clearance, and shop floor compliance. Ensure adherence to GMP/cGMP guidelines and company policies. Key Skills Required: Strong knowledge of QMS and Documentation practices. Unders...

Key Responsibilities: Project Planning and Forecasting: Plan and forecast project schedules, milestones, and deliverables to ensure timely completion. Installation, Commissioning & Maintenance: Supervise the installation, commissioning, and maintenance of HVAC systems, utility equipment, and process pipelines. Compliance and Troubleshooting: Ensure all activities comply with GMP and pharmaceutical API standards. Troubleshoot and resolve issues encountered during project execution. Documentation: Prepare and maintain project documentation, including SOPs, validation reports, and other relevant documents. Budget and Resource Management: Monitor project budgets and manage resources efficiently ...

Roles and Responsibilities: Supervise and manage daily manufacturing operations in accordance with pharmaceutical production standards, including GMP and SOP compliance. Collaborate with the maintenance team to improve the reliability and efficiency of production machinery. Ensure safe operation of all equipment and enforce safety protocols within the production area. Monitor and support mechanical aspects of pharmaceutical production processes and machinery. Identify and address any mechanical issues impacting production performance. Qualifications: Educational Background: B.E./B.Tech in Mechanical Engineering (Production specialization preferred) Experience: 24 years of experience as a Pro...

As a General Manager in the pharmaceutical and industrial sectors, you will be responsible for overseeing the overall operations of a facility or business unit. Your primary goal will be to ensure efficiency, productivity, and profitability while aligning operations with the company's strategic goals. This role will involve strategic planning, budget management, team leadership, and maintaining compliance with industry regulations. You will play a crucial role in developing and implementing business strategies, policies, and procedures to achieve company objectives. Your key responsibilities will include overseeing daily operations, optimizing performance across various departments, managing...

You will be playing a crucial role in advancing Digital Shop Floor technologies, collaboration, and leadership across the organization, with a specific focus on automation systems used in vaccine, biologics, and small molecule manufacturing processes worldwide. Your responsibilities will include providing technical guidance globally, leading sub teams, implementing proof of concepts, and consulting on various solutions. Additionally, you will support site operational teams in overcoming day-to-day challenges related to lifecycle management. Collaboration with business stakeholders, IT technical staff, and other engineering groups will be essential to ensure high operational efficiency of key...