489 Deviation Jobs

Purpose/Objective Officer - Safety is responsible for implementing QSHE (Quality, Safety, Health, and Environment) policies and procedures, identifying and mitigating risks, and ensuring a safe and healthy work environment. The role involves auditing, investigating incidents, and providing safety support and guidance to line managers, as well as ensuring compliance with relevant statutory requirements. Key Responsibilities of Role Safety Program Implementation: Implement Safety policies and procedures in the allocated area, ensuring adherence to company and industry safety standards. Safety Objectives & Action plans: Advise and assist line managers in planning, organizing, and maintaining a ...

Role & responsibilities QMS Related Activity: - 1. Handling of market complaint investigation, documentation and follow-up and reports closure 2. Handling of CAPA & change control activity. 3. Issuance, control and retrieval or batch records, SOPs, Logbook, and other documents. 4. Prepare and review Annual product quality review. 5. Management of control sample room. 6. Preparation and review of SOP. IPQA Related Activity: - 7. To take shop floor round and do gap analysis between practices followed vs GMP practices. 8.. To review all executed BMR, BPR and Final Batch Release of Finished Product in SAP for Sale or Distribution. 9.To perform line clearance and In-process checks in manufacturin...

Key Responsibility area /Activities Documentation & Review of analytical data (RM, PM, SFG, FG, Stability,Hold time, PV, CV, WS, Water, Volumetric solutions,Calibration etc.,) hard copy and as well as electronic data (LabWare LIMS, Empower and other instrument software). Verification of instrument usage logbook and e-Logbook Review of certificate of analysis. Online review of electronic data and documents. To review / Approve instrument methods created on Empower and other standalone instruments. To review the electronic data in LabWare LIMS. To review the audit trail of computerized systems Review of Stability Study Records and summary reports. Handling of Issuance, retrieval, destruction o...

USV (Pharma) is Hiring Senior Manager - QA (Sterile) for USFDA Formulation Manufacturing Plant based at Daman near Vapi. We are looking for dynamic professionals having more than 15 years of experience in hard core injectables (Liquid Vials, Ophthalmic and Pre-filled syringes). The incumbent must be having the thorough knowledge of IPQA, Qualification and Validation, QMS Aseptic techniques and practices. Should have faced the Regulatory Audit (USFDA, MHRA, EU GMP, TGA) and should be able to explain the auditors during inspections. Excellent verbal and written communication are expected. Oversee and manage QMS processes including Deviation Management, CAPA, Change Control, Risk Management, an...

Roles and Responsibilities Ensure compliance with regulatory requirements such as GMP, CGMP, USFDA, MHRA, GLP, and WHO guidelines. Conduct audits to identify deviations and implement corrective actions to maintain regulatory compliance. Manage BMRs (Batch Manufacturing Records) and ensure accurate documentation of manufacturing processes. Develop and implement effective compliance management systems to prevent non-conformities. Collaborate with cross-functional teams to resolve issues related to product quality, safety, and regulatory affairs.

Purpose/Objective Team Member – CPAG is responsible for executing day-to-day project assurance tasks including MIS preparation, documentation validation, NFA checks, and data collation for budgeting and reviews. This role works under the guidance of CPAG leads to ensure accurate tracking of project performance metrics, timely execution of assigned tasks, and maintenance of digital records and compliance documentation. As the operational backbone of the assurance process, the team member ensures CPAG’s standards are upheld at the ground level and supports continuous improvement initiatives through active participation and feedback. Key Responsibilities of Role Project Performance Monitoring a...

Purpose/Objective Team Member – CPAG is responsible for executing day-to-day project assurance tasks including MIS preparation, documentation validation, NFA checks, and data collation for budgeting and reviews. This role works under the guidance of CPAG leads to ensure accurate tracking of project performance metrics, timely execution of assigned tasks, and maintenance of digital records and compliance documentation. As the operational backbone of the assurance process, the team member ensures CPAG’s standards are upheld at the ground level and supports continuous improvement initiatives through active participation and feedback. Key Responsibilities of Role Project Performance Monitoring a...

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...

Job Title :Sr. Executive/Assistant Manager Functional Area : Quality Assurance Key Accountabilities Technical and QMS Documentation: Preparation and Review of Documents as per ISO 13485, EU-MDR, 21CFR820, Thai FDA and Indian Medical Device Rule and ensure implementation of same. Handling of Deviation, Non-Conformance, Change controls and CAPA. Handling of Post market surveillance Preparation of the regulatory documents (TMF/Dossiers) for regulatory submission. Preparation of Technical files in co-ordination with R&D Team. Preparation of Design file as per ISO 13485:2016, MDR and USFDA. Handling of Adverse event reporting to EU and other regulatory body. Familiar to handle Eudamed, Maude and ...

0 Responsibilities: To carry out the following routine checks in the laboratory on daily basis: Responsibility for investigation report writing and closure of deviation, OOS and OOT. Qualification of working standards. Glassware verification & labelling. Routine calibration and verification of all instruments. Logbooks verification. To ensure that the documentation done is online and error free. To ensure the correctness of the document before submitting it for the review of Group Leader/AQA reviewer. Column stock, inventory, indent, requirement and routine usage verification. Reference/Working standard and impurities verification. Area upkeep and maintenance. Calibration schedule/document/l...

Preferred candidate profile Diploma in pharmacy/mechanical/electrical with minimum 1 year experience in OSD production. Recruiter Mohaneswara https://www.linkedin.com/in/mohaneswarareddy Role & responsibilities Operate Fluid Bed Equipment and Spheroniser as per SOP, including cleaning and line clearance activities to ensure readiness for production. Strict adherence to safety, health and environment. Carry out Manufacturing activities by following and monitoring standard operating procedure (SOP) and current Good Manufacturing Practice (cGMP). To ensure effective implementation of RFT and Data integrity policy. Maintenance, upkeep of the department, premises, and equipment. To maintain disci...

Role Summary – Production executive Follow established procedures and guidelines to operate the process units, load/unload storage tanks and manufacture chemical products. RESPONSIBILITIES: Safely operate and work with industrial equipment using the proper PPE and safety procedures. Process chemical products using batch sheet instructions. Includes manual and DCS operation. Loading, Unloading and sampling of material containers (tank cars/trucks, drums) in the plant whenever required. Track/record process information and production data. Production data entry in ERP – SAP system Report non-conformance/ deviations to shift in charge and participate in troubleshooting equipment, processes, etc...

As a Stability Study Manager, your role involves managing and overseeing stability study processes to ensure compliance with regulatory requirements and maintain the integrity of stability data. You will coordinate stability analyses, handle audits, and support quality management systems (QMS) to uphold the highest standards of quality and compliance. Key Responsibilities: - Coordinate with the Quality Control team for stability analysis and retrieval of stability data. - Prepare stability study protocols and conduct gap assessments in stability analysis. - Arrange stability samples and conduct daily reviews of temperature and relative humidity (RH) printouts. - Provide stability data for re...

Overview The Derived Data Analyst will assist with the management and audit of BMU Data and all related activities ensuring Data and Universe Analytics products are supported by research-quality data. If you are deeply passionate about the private capital industry, possess a keen eye for detail, and have robust analytical skills, this is an exceptional chance to become part of a thriving, rapidly expanding team committed to setting the industry benchmark for high-caliber private capital data. Responsibilities Assist with the management of the Burgiss Manager Universe dataset production, collaborating closely with Engineering, Product Management, Operations, and other key teams. Oversee the g...

Title: Asst. Manager- Instrumentation & Control Custom Field 2: 1121 Location: Bavla, Gujarat, IN Country/Region: IN State: Guja City: Bavla Company: Dishman Carbogen Amcis Limited Business Unit: General Travel Description: Key Skills RequiredArea of expertise: Calibration Documentation Review, Thermal Validation, PLC and CSV Validation, QMS , Change Control, Deviation , CAPA. Experience in the field of Automation (PLC programming/SCADA). Knowledge of different types of network protocols like BACNet, LON, Modbus, OPC, and other protocols. MP documentation, guideline, documentation flow, Impact assessment , QMS, thermal validation/area temp mapping, Green/brown field project erection/commissi...

We are Hiring a Utility Engineer (Water Systems) for a leading Global Pharmaceutical Packaging Brand. Location: Umarsadi, Valsad Experience : Minimum 3 to 5 years of relevant experience in Water System. Experience in WFI (water for injection) & PW (Purified water) is mandatory Role : This profile will be responsible for ensuring reliable and compliant operation of all water systems like WFI, Purified water, etc through routine monitoring, maintenance, and strict adherence to GMP and regulatory standards. Main Task: Ensure smooth operation & preventive maintenance of WFI, purified water, PSG, HSRO & CSRO systems. Monitor system parameters, conduct routine checks & maintain logbooks Liaise wit...

Roles and Responsibilities Manage contracts from initiation to closure, ensuring compliance with company policies and regulatory requirements. Conduct BPR reviews, audits, and quality checks to ensure adherence to IPQA standards. Develop and maintain documentation related to contracts, including change controls, deviations, and non-conformities. Collaborate with cross-functional teams for effective project management, planning, reporting, and training. Ensure timely completion of tasks by monitoring progress against schedules and identifying potential roadblocks.

Key responsibilities: Executes online Batch Packing Records, online in process as per the parameters mentioned in the BPR, logbook, documents and other formats. take line clearance of area / machine as per respective SOPs. maintain / fill all area / machine related documents like Sequential, area cleaning, daily cleaning log books and other formats of machine & area as per SOP. verify and receiving of dispensed packing material. indent / receive / handle / verification / uses & destruction of stereo as per respective SOP. verify the Leak test of blister / strip as per frequency. If result not satisfactory, rectify the problems. maintain, handle / storage / labelling of machine spares /change...

QA documentation, specifications, & analysis protocols, ensuring cGMP compliance through QA rounds, line clearance, in-process monitoring validation oversight, final product inspection, dispatch coordination & reserve sample management.

Perform analysis of RM/IP/FP/API samples using HPLC/GC. Conduct method validation, stability studies, documentation, and ensure cGMP, GLP & data integrity compliance. Handle OOS/OOT, maintain instruments, and support audits.

Hands-on with reactor operations, filtration, drying, and crystallization. Experienced in batch processing, in-process monitoring, and scale-up activities.Strong understanding of Good Manufacturing Practices (GMP) Required Candidate profile - Education: B.Sc./M.Sc. in Chemistry/Pharmaceutical Sciences - Experience: 1–2+ years in API Production Perks and benefits GMP GLP plant| Growth| Safety| Compliance| Perks

Job Description Officer - Production Execute the production plant as per Shift Operations to achieve the consistent product quality, quantity and yield. Trouble shooting of process and operational issues on the shop floor. Monitor and maintain all parameters as per SOPs and ensure strict compliance with cGMP and Safety norms. Ensure that all production activity performed as per the SOP and as per BMR. Preparation/review of SOPs/BMR/BPR/ ECR and formats. Preparation/review of Equipment Qualification/Re-qualification protocol and report. To handle the manpower as per work planning. Review of validation protocol and report. Responsible for raise the change control and its implementation. To pro...

Roles and Responsibilities Maintain accurate records of all quality-related activities and reports. Conduct quality audits, internal audits, external audits, customer audits, BMR review, capa, change control, OOS, GMP compliance, deviation management, root cause analysis, SOP preparation, and QMS implementation. Ensure adherence to cGMP guidelines during production runs. Identify areas for improvement through continuous monitoring of processes and implement corrective actions. Collaborate with cross-functional teams to resolve quality issues and improve overall productivity. Document issuance (i.e., Batch Manufacturing Record , Lab Note Book, Log books, analytical work sheets, SOP formats et...

Sr. Officer - QALL: Work Location - Baddi, Baroda & Navsari Ensure GMP/GLP compliance at Contract Manufacturing sitesand third party sites and provide registration documents and required support for registration from site. Ensure availability of current valid masterdocuments like raw material /packing material /finished product specificationsbatch manufacturing record /batch packing record at site and retrieval ofobsolete documents. To check and find non compliances at Contract Manufacturing /Third Party location and ensure corrective and preventive action. To execute, ensure and monitor processvalidation / Technology Transfer activities, Unit Operation, QMS Compliance atsite and arrange for...

Division Department Sub Department 1 Job Purpose Monitor and execute the packing activities in a shift by maintaining cGMP and safety norms to achieve production targets Key Accountabilities (1/6) Execute shift packing activity by managing available resources and reduces micro stoppage of machine to achieve shift target Utilise shift resources optimally to get desired production output Regulate usage of consumables in the production process at optimum level to save cost Key Accountabilities (2/6) Review documentation related to packing activity and monitor standard packing parameters as per BPR to meet regulatory requirement Review and monitor critical in-process parameters like NFD, camera ...