102 Deviation Management Jobs

As a Manager at Sun Pharma Laboratories Ltd in Guwahati, in the Regulatory Affairs department, your role involves the following responsibilities: - Facilitating harmonization and consistent implementation of Quality System and procedures at the site in alignment with Corporate Quality Policies/Procedures. - Reviewing documents related to Quality Management System (QMS) & Compliance. - Ensuring compliance with the Quality Management System. - Attending Site Training Program as per site training program and Global Quality Standards requirements. - Submitting Dossier documents after reviewing them against requests received from Corporate regulatory affairs. - Responding to queries on submitted ...

Responsibilities: Maintain QMS. Calibration Process & cleaning validation Conduct & document annual training Pest Control Review BMR & BPR APQR Change Control CAPA Deviation Eqp. Qualification Perform other quality tasks as instructed by Manager Office cab/shuttle Annual bonus Provident fund Job/soft skill training Travel allowance House rent allowance

Line Clearance for Dispensing, Manufacturing & Packing activities Dispensing of RM/PM for batch Mfg Monitoring of IPQA activities (Granulation, Blending, Capsulation, Compression, Coating, Packing Sampling of IP and FP Samples Batch documents review

Position Summary The Manufacturing Senior Executive / Assistant Manager will provide documentation and process support to the on-site manufacturing team. This role includes preparing essential documents, initiating quality system events, and coordinating with cross-functional teams to ensure smooth manufacturing operations. The role requires strong documentation skills, understanding of manufacturing processes, and the ability to work independently in a virtual environment. Key Responsibilities Documentation Support Provide comprehensive backend documentation support to the manufacturing team and collaborate virtually with on-site teams. Prepare, review, and update Standard Operating Procedu...

Position Summary The Manufacturing Manager/Senior Manager will provide technical, documentation, and quality system support to on-site manufacturing operations. This role involves managing manufacturing documentation, monitoring performance metrics, driving process improvements, and coordinating with cross-functional teams to ensure seamless execution of production activities in alignment with cGMP standards. Key Responsibilities Documentation & Quality System Support Provide end-to-end documentation support from the India team and work virtually with the on-site U.S. team. Initiate and review Change Controls , Deviations , and CAPA within the Quality Management System (QMS). Prepare and rev...

You will be responsible for the issuance, control, and retrieval of documents. Your duties will also include scanning and uploading approved paper-based documents in Veeva Vault, as well as maintaining master copies for SOPs. Additionally, you will be involved in conducting and organizing training sessions, maintaining Vendor audit and Technical agreement planners, and preparing/reviewing SOPs, Protocols, and other cGMP documents. You will also be tasked with tracking Change control, CAPA, Deviation, OOS/OOT, and coordinating with stakeholders for timely closure. Location: Ferring India Laboratories,

As a Site Quality Head at our reputed pharmaceutical manufacturing company in Vapi, Gujarat, you will play a crucial role in leading and overseeing the Quality Assurance and Quality Control functions at our Oral Solid Dosage (OSD) facility. Your responsibilities will include: - Leading and managing the complete Quality function (QA and QC) at the site - Ensuring compliance with GMP, regulatory, and customer requirements - Overseeing quality systems such as deviations, CAPAs, change controls, validations, and documentation - Monitoring and guiding all laboratory operations, including chemical, instrumentation, and microbiological testing - Preparing for and leading regulatory and customer aud...

Role Overview: As an Infrastructure Compliance professional, your primary responsibility will be to ensure adherence to standard operating procedures (SOPs), work practices (WPs), and ways of working related to topics such as Infrastructure Qualification. You will play a crucial role in supporting audit activities, SOX IT control testing, vulnerability management, risk and issue management, and access management. Additionally, you will be responsible for managing various applications and tools related to Infrastructure Engineering Services (IES), conducting ITSM quality checks, and overseeing training management to enforce policy adherence. Key Responsibilities: - Audit Support, including ac...

Job Title: Quality Auditor Specialist Department: Retail Operations Enrich Salon Stores, Pune, covering all stores in Pune. About the Role The Quality Auditor – Specialist at Enrich Salon Retail Stores ensures that customer interactions and in-store service delivery meet the highest standards of quality and compliance. This role involves monitoring calls, evaluating store-level performance, analyzing trends, and preparing actionable reports using advanced tools and Excel dashboards. The position requires strong analytical skills, attention to detail, and the ability to collaborate effectively with store teams and leadership. Role & responsibilities 1. Call Monitoring & Evaluation Monitor inb...

Responsibilities: Overall installation & maintain of HVAC systems. Ensure compliance with GMP & USFDA standards. Manage deviations & implement CAPAs. Conduct RFM audits & FMS inspections.

Role Overview: As an AIN Specialist QA at Amgen, you play a critical role in supporting product disposition related tasks across the Amgen Quality Operations Network. Your responsibilities include leveraging industry, technical, and quality systems knowledge to provide support for product expiry management processes, product complaints processes, disposition manager training, and fulfilling disposition related data requests across the network. You will primarily work during regular working hours to enable the business in delivering Amgen's mission to serve patients and may lead a shift-based team providing coverage across multiple time zones. Your role is essential in ensuring the quality an...

Key Responsibility: Manufacturing Oversight: 1. Shop Floor Oversight: Monitor and oversee sterile injectable manufacturing activities on the shop floor to ensure adherence to cGMP, SOPs, and regulatory requirements Provide real-time guidance and decision-making during production to ensure product quality and compliance 2. Batch Manufacturing Record (BMR) and Batch Packaging Record (BPR) Prepare, review, and approve BMRs and BPRs to ensure accurate documentation and compliance with manufacturing procedures Ensure completeness, accuracy, and timely review of all manufacturing records 3. In-Process Quality Checks: Perform in-process quality checks during manufacturing stages to ensure critical ...

Key Responsibility: Validation Activities: 1. Media Fill Studies: Plan, execute, and review media fill trials to ensure aseptic process integrity. Analyze results and recommend corrective actions when necessary. 2. Area Qualification: Oversee qualification of classified manufacturing areas (Grade A-D). Perform routine re-qualifications and environmental monitoring to ensure regulatory compliance. 3. Equipment Qualification: Develop and execute protocols for Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) of manufacturing equipment. Review and approve qualification documents. 4. Utility Qualification: Validate critical utilities such as HVAC...

Role Overview: As a Manager - Quality at Dishman Carbogen Amcis Limited in Bavla, Gujarat, IN, you will be responsible for various quality management tasks including handling change control, deviations, CAPA management system, internal and external audits, and ensuring equipment and utility qualification. Your role will require a thorough understanding of regulatory guidelines, cGMP norms, GLP, GDP, and data integrity requirements. Additionally, you should have experience in regulatory audits. Key Responsibilities: - Handle change control processes effectively - Manage deviations and CAPA management system - Conduct internal and external audits - Ensure equipment and utility qualification - ...

Role Overview: As a QA/QC Manager in the cosmetics sector, your role will involve overseeing a wide range of quality systems to ensure regulatory compliance and drive continuous improvement in product and process quality. You will be responsible for leading teams, implementing quality management systems, and managing various validation activities. Key Responsibilities: - Implementing and overseeing Quality Management Systems (QMS) including change control, deviations, CAPA, and OOS/OOT investigations. - Ensuring regulatory compliance with guidelines such as cGMP, GLP, and other relevant standards. - Managing and executing validation activities for products, processes, and equipment. - Leadin...

Job Title: Senior Officer to Senior Executive QMS (Production) Section: QMS - Production - API Mfg. Department: Production Qualification: M.Sc. (Chemistry) / B.E. (Chemical) Experience: 5 to10 years Location: Raks Pharma Pvt. Ltd. Dahej, Bharuch, Gujarat Job Description We are looking for an experienced QMS professional for our Production Department who will be responsible for ensuring compliance with cGMP, documentation practices, validations, and audit readiness. Key Responsibilities: Prepare new SOPs and revise existing SOPs as per requirements, periodic updates, and audit recommendations, including review and implementation for the Production department. Carry out process validation and ...

Role Objective A key objective of this position is to ensure adherence to global regulatory standards and best practices while maintaining robust quality systems. The role focuses on implementing effective quality processes, driving continuous improvement initiatives, and fostering a strong culture of compliance to guarantee the safety, efficacy, and quality of injectable products. Desired Candidate Profile M.Sc. / M.Pharm / B.Pharm / B.E. in Life Sciences or Engineering. Minimum 16+ years of relevant leadership experience in Quality Assurance, including Site Quality leadership. At least 10+ years of experience in supervising, managing, and directing teams. Demonstrated knowledge of cGMPs, g...

Role Overview: You will be overseeing manufacturing and production operations at Dr. Reddys Laboratories Ltd., ensuring compliance with regulatory audits and managing equipment, process validation, and various activities related to production and manufacturing. Key Responsibilities: - Handle line operations, specifically production and manufacturing activities like CIP (Cleaning-in-place), SIP (Sterilizing-in-place), and batch manufacturing. - Manage equipment such as Steam Sterilizer, Dry heat sterilizer, HVAC (Heating, Ventilation, and Air Conditioning), water system, compressed air, Nitrogen system, etc. - Perform process validation for Sterilization, Washing, Aseptic filling, and cleanin...

As a Discoverant Specialist at Novartis, you will be responsible for supporting the Discoverant System Business Owner within Novartis Technical Operations (NTO). Discoverant is a validated IT solution used across NTO for automated manufacturing data aggregation, advanced analysis, and comprehensive reporting. Your role will involve collaborating with IT teams, manufacturing sites, and the Discoverant Global Business Owner to ensure optimal system setup, seamless change implementations, and ongoing maintenance of the Discoverant platform across the Novartis network. **Key Responsibilities:** - Serve as the primary business-side representative for the implementation, lifecycle management, and ...

As an Investigation and Deviation Specialist at Novartis, you will collaborate with process experts and multifunctional operations teams in Radio Ligand Therapy (RLT) platform sites. Your primary responsibility will be to take ownership of deviation management for the site, actively participating in investigations of deviations, complaints, and OOXs by interacting with Cross-Functional Teams (CFT) and implementing Corrective and Preventive Actions (CAPA), Effectiveness Checks (EC), risk assessments, and quality management. Your role will also involve facilitating effective communication between teams and supporting problem-solving activities. **Key Responsibilities:** - Manage deviations in ...

QC & Formulation Development – Dental Products Person with hands-on experience in testing and developing dental materials such as powders, gels, pastes, cements, composites, and resin-based systems, includes QC testing, formulation trials, method Required Candidate profile Conduct QC tests, evaluate materials, support formulation development, run lab trials, follow ISO standards, prepare documentation, and coordinate with QA, R&D, and Production for batch and scale-up.

Line Clearance for Dispensing, Manufacturing & Packing activities Dispensing of RM/PM for batch Mfg Monitoring of IPQA activities (Granulation, Blending, Capsulation, Compression, Coating, Packing Sampling of IP and FP Samples Batch documents review

Description JOB DESCRIPTION The role involves reviewing and executing qualification and validation documents for equipment, facilities, and utilities. Key tasks include preparing validation protocols, coordinating with teams, ensuring c-GMP compliance, and providing training on validation processes. Essential Functions Responsible to review and execution of qualification document related Equipment, Facility and Utility like Plant equipment, HVAC, Water system and Compressed air system. Responsible to review and execution of Re-Qualification document. Responsible to co-ordinate with manufacturing personnel for respective qualification / validation / Re-qualification activity form timely compl...

As a Quality Management System (QMS) Specialist, your role will involve establishing, implementing, and continuously improving the company's QMS to support its clinical-stage biopharmaceutical development programs while ensuring compliance with regulatory requirements such as FDA, EMA, ICH, and GxP standards like GMP, GDP, GCP, GLP. Your responsibilities will include: - **QMS Development & Implementation**: - Developing, implementing, and maintaining a phase-appropriate QMS aligned with regulatory requirements. - Establishing, reviewing, and updating Quality System documentation to support GxP operations. - Serving as the system owner for the electronic QMS and ensuring effective document co...

Role Overview: You are being offered the position of Assistant Manager Quality Assurance (QA) at Natural Biogenex Private Limited (NBPL), a subsidiary of Natural Capsules Limited. NBPL is a specialized API manufacturing company located in Tumkur, Karnataka, committed to producing high-quality steroidal APIs and intermediates while adhering to global regulatory and compliance standards. As an Assistant Manager QA, your primary responsibility will be to ensure compliance with current Good Manufacturing Practices (cGMP), regulatory guidelines, and industry standards to uphold the company's commitment to excellence, compliance, and continuous improvement in API manufacturing operations. Key Resp...