335 Deviation Jobs - Page 10

Qualification : B.Pharma Experience : 3 to 10 yrs. Designation : Officer Salary Range : 6 to 7 Lacs PA. Unit : Injectable Kindly Find the JD. Management of Aseptic Process Simulation (Media Fill) Program. Review of quality systems such as Change Control, Deviations, CAPA, OOS, OOT, LIR, Market Complaint, FAR, Product Recall and other QAMS documents. Preparation and Review of APQR. Nitrosamine Risk Assessment of Drug Product Preparation and review of site QA SOP and review of cross-functional department SOP. Review of Batch Manufacturing Record and Batch Packing Record. Preparation, review and execution of hold time study of drug product. Preparation and review of thermal cycling and temperat...

Role & responsibilities Job Summary We are seeking an individual for the Quality Control Microbiology team, responsible for review and approval of microbiology analytical data/record, review of EM and water trend, monitoring of aseptic process simulation. Review and approval of Analytical method validation related to Microbiological test. This role includes the participation into investigation related to Microbiology Roles & Responsibilities Responsible for Review and release of Microbiological Tests (Environmental Monitoring, Water Testing, Microbial Limit Test, Sterility Test and Bacterial Endotoxins Test). Responsible for review and Approval of Microbiological testing data/ Master data in...

Job Responsibilities: 1. Monitoring and Assessment of QMS related activities for all API sites (Nerul, Chiplun and Ambernath) and Govandi (CPRL, PAN, BRL etc.). 2. Change Controls: Review and closure of change controls, approval and closure of actions childs, CQA Assessment etc., 3. Review of Customer Complaints, Risk Assessments, Deviations, CAPAs, Investigations, Recalls etc., 4. Handling of Customer Quality agreement and co-ordination with cross functional team till execution of the agreement. 5. Tracking of CQA SOPs as per the review date, by maintaining the SOP Periodic review tracker and master SOP list. 6. Preparation/Revision of CQA SOPs and making master, effective after completion ...

Job Summary We are seeking an individual to verify compliance for activities in the respective counter function regularly. This role involves reviewing real-time investigations, ensuring smooth batch manufacturing and testing activities, and evaluating practices against defined standards, to ensure consistent product quality and operational compliance within the regulatory framework and global standards. " Roles & Responsibilities You will be responsible for executing or assigning in-process activities during shifts, conducting line clearances, material verification, overseeing start-up of machines, and coordinating sampling activities to ensure product quality and compliance. You will be re...

Job Summary We are looking for an individual for the SIT Team to oversee the investigation of major and critical deviations, working closely with Cross-Functional Team (CFT) members to identify root causes and implement corrective and preventive actions. The role involves active participation in investigating Out of Specification (OOS) cases, ensuring accurate classification in the DCMS deviations log, and providing support during regulatory inspections. Roles & Responsibilities • You will be responsible for overseeing the investigation of major and critical deviations from the outset, collaborating closely with Cross-Functional Team (CFT) members to identify root causes, corrective actions ...

Immediate joiners are preffered. Interested candidates can share resume on dipika.parmar@milanlabs.com 1.To review and implement Quality Management System for cGMP compliance at site. 2.To review and approve of product design. 3.To review and approval of production and quality control documentation for compliance with GMP and GLP requirements. 4.To Handle Caliber BRM, QAMS, DMS, Nichelon 5 CMS, E-logbook, E-schedule, Microsoft Dynamic, NCR 5.To review and approve SOPs, Validation Protocols, Master Batch Production Records and other related documents at site. 6.To review and approve Change Control, Incident /Deviations and ensure its closure, within given timeframe as per respective SOP. 7.Ap...

Job Description Conduct all tasks/ activities as per the applicable SOPs. Report any difficulty or deviation in the procedures/instructions to immediate Supervisor/Managers. Report any quality concerns or suggestions for improvements to Supervisor/ Managers.Preparation and Review of Quality Assurance SOP’s. Review of other departments SOP’s. Review of Master Documents such as BMR/BPR, Test batch monitoring protocols / process validation protocol and reports etc. Initiation and log in of Quality System document such as Deviation, Change Control, OOS, OOT, market complaint, Annual product review and Non conformities. Work Experience 3-5 Years Education Graduation in Pharmacy Competencies

THE POSITION: We are looking for a Data entry Analyst to update and maintain Pharmaceutical global tenders’ information. ESSENTIAL DUTIES AND RESPONSIBILITIES: Data Entry responsibilities include collecting and entering data in databases and maintaining accurate records. Compile, verify accuracy and sort information according to priorities to prepare source data Review data for deficiencies or errors, correct any incompatibilities if possible Research and obtain further information from documents Store completed work in designated locations and perform backup operations Comply with data integrity and security policies They can perform repetitive tasks with a high degree of accuracy in an eve...

Lead a team to drive excellence in investigation, compliance, and continuous improvement. • Continuously improve capabilities for manufacturing operations. • Prioritize timely investigation and operational improvement with a strong focus on results. • Identify root causes using the right investigation tools and implement effective CAPA (Corrective and Preventive Actions). • Work on procedural gaps to prevent deviations. • Develop a compliance mindset within the team. • Strengthen integrity and right-first-time culture within the team. • Identify improvement opportunities in processes and procedures, removing non-value-added steps. • Use operational excellence tools to identify and minimize a...

As a Quality Assurance Officer in the IT Shared Service Center, you will be responsible for ensuring the quality of our software products and services. You will be involved in all stages of the software development process, from initial specification to final testing. Your role will be critical in ensuring that our software meets the highest standards of quality and usability.

As a Quality Assurance Officer in the IT Shared Service Center, you will be responsible for ensuring the quality of our software products and services. You will be involved in all stages of the software development process, from initial specification to final release. Your primary goal will be to ensure that our products meet the highest standards of quality and provide a seamless experience for our users.

JD: 1) To be prepared document related to audit as per audit agenda. 2) Filled vendor questionnaires & prepared related documents. 3) Keeping record of key Customer. 4) To be prepared process validation protocol and report as per seniors guidance. 5) To be prepare cleaning validation protocol and report as per seniors guidance. 7) To be prepared master, controlled, uncontrolled, reference, obsolete & distribute documents as per SOPs and formats requirement. 8) To help the senior for preparation of CAPA according to audit report. 9) Issuance of Change control, OOS, deviation & other QMS formats whenever required from respective department and retained record in logbook. 10) To be prepared BPC...

Overseeing all training activities to ensure team competency and compliance. Help in Conducting audit planning and executing audits of various applications and departments. Reviewing validation documents to ensure compliance and accuracy. Performing peer reviews of audit plans, reports, and observations, and effectively communicating with auditors to clarify findings, ratings, and supporting evidence. Managing change requests, deviations, quality issues, CAPA (Corrective and Preventive Actions), effectiveness checks, and conducting root cause analysis. Assisting in the development of Key Performance Indicators (KPIs) for Quality Management System (QMS) performance monitoring and management o...

Job Description 1) Supervise compliance to all cGMP, GxP, or any other regulatory requirements, Including EH&S requirements. 2) Execute and supervise all tasks and activities as per the applicable SOPs. 3) Complete self-training and monitor training of team members on the relevant SOPs. 4) Report any quality concerns or suggestions for improvements to Managers. 5) Review of Master document such as Validation protocol and reports. 6) Review and monitoring of Quality system document such as deviation, change control, OOS, OOT, Vendor complaint, CAPA, Risk assessment, Non conformities, Internal Audit & Market Complaint. 7) Ensure preparation and periodic review / updation of APQR. 8) Preparatio...

Role & responsibilities Responsible for managing and maintaining Quality Management System (QMS) activities within the Supply Chain Management (SCM) department, including Change Control, Deviation, and CAPA management. Ensures daily operations and documentation are in compliance with cGMP and regulatory standards. Supports audit readiness and continuous improvement initiatives within SCM.

Roles and Responsibilities Conduct quality audits, BMR reviews, CAPAs, deviation investigations, change controls, equipment qualifications, process validations, and vendor qualifications. Ensure compliance with USFDA regulations through IPQA activities Engineering Documentation ,Qualifications &Validations. Warehouse Documentation ,Qualifications &Validations. Cleaning Validation Perform analytical QA tasks such as OOS management and sterility testing. Participate in MHRA / USFDA inspections by providing necessary documentation and supporting audit findings. Collaborate with cross-functional teams to resolve quality issues. Regulatory Audit Exposer LIKE FDA, MHRA, TGA Audit Reponses and Audi...

Oversee and optimize the Pilgering process for manufacturing stainless steel seamless tubes. Ensure the tube reduction process meets required dimensional accuracy, strength, and surface finish standards. Troubleshoot and resolve any issues in the Pilgering process, ensuring minimal downtime and optimal throughput. Implement rigorous quality control measures throughout the production process to ensure that the final products meet high standards of quality, including strength, dimensional accuracy, and surface finish. Monitor and maintain Pilgering machinery and related equipment to ensure optimal performance and longevity Coordinate with production teams to schedule and prioritize the manufac...

Job Objective : 1. Excellent team player/leader can efficiently motivate the subordinates to achieve the set targets within stipulated time. 2. Proficiency in written and oral communication skills. 3. Ensuring best in class quality and timely project execution 4. Strong initiative in decision making and owing up of responsibilities. 5. Strongly believe in turnaround of Business, systems and procedures with an integration of internal skill set along with outstanding team building. Job Role: 1. All activities related to production and monitoring the process as per SOPs. 2. Communicate day to day process deviations and breakdowns of the equipment to concerned persons. 3. Check and implement the...

Carry out manufacturing activities as per Batch Manufacturing Records (BMR) and SOPs. Monitor and control production parameters to meet quality and output targets. Ensure timely completion of batches to meet production schedules. Ensure adherence to current Good Manufacturing Practices (cGMP) and company policies. Report and document any deviations, incidents, or abnormalities during production. Operate, clean, and maintain manufacturing equipment (e.g., granulators, blenders, tablet compression machines, filling machines). Perform line clearance, changeovers, and cleaning as per SOPs. Maintain accurate and timely records of all production activities. Fill out logbooks, checklists, and BMRs/...

Planning & Co-ordinate Internal/ External/Customers Audits. Reviewing Customer audits and non-conformity reports and ensuring corrective actions are effectively implemented. Validation protocols and reports. Reviewing BMR, Analytical Records.

Spica Labs Pvt. Ltd. is hiring QC & QA male candidates with experience in HPLC, UV, IR, GMP, BMR review, SOPs, validation, deviations & regulatory knowledge. Send resumes to: spicalabspvtltd@gmail.com.

Operate and monitor packing machinery for dry powder pharmaceuticals. Ensure that powder is packed in correct quantities, weights, and packaging specifications. Perform routine checks to maintain machinery in optimal working condition. Verify packaging materials, labels, and batch records to ensure compliance with regulatory and quality standards. Perform in-process inspections and checks to ensure proper filling, sealing, and labeling. Report any deviations or discrepancies to the supervisor and take corrective actions. Follow all GMP guidelines and maintain a clean and safe working environment. Ensure compliance with SOPs (Standard Operating Procedures) and regulatory requirements. Maintai...

Dear Candidate, We are conducting walk-in drive on 27th June (Friday) for the positions in our Quality Assurance department. Job Description : Position Name: Fresher/Executive Experience - 0 -5 years Qualification - M.Sc Chemistry /M.Pharma Designation - Executive Walk-in Date: 27th June 2025 (Friday) Time: 09:00 AM to 12.00 PM Chemveda is hiring for Quality Assurance Executive Position Job Responsibilities :- 1. Involves in daily QA activities for SOP compliance. 2. Equipment and Software qualifications Review of USR & SRS, Review of IQ, OQ, PQ document inhouse softwares and maintenance of Equipment and software related back up coordination with other departments. 3. Preparation of refresh ...

Supervise day-to-day operations of the external preparation manufacturing section. Ensure proper execution of batch manufacturing processes as per Batch Manufacturing Records (BMRs) and Standard Operating Procedures (SOPs). Coordinate with Quality Assurance (QA), Quality Control (QC), Warehouse, and Maintenance for smooth operations. Monitor equipment calibration, cleaning, and maintenance to ensure readiness for production. Ensure proper line clearance, area cleaning, and equipment readiness before starting manufacturing operations. Review and maintain manufacturing documentation, including BMRs, logbooks, and deviation reports. Handle in-process checks and ensure process parameters are mai...

Job Description: Proffered Profile: Bachelors degree (BE/B tech) with 3-5 years of experience in IT QMS Compliance Specialist ensures alignment of all IT systems, processes, and documentation with internal Quality Management Systems (QMS) and applicable regulatory standards such as GxP, ISO 9001, 21 CFR Part 11, and EU Annex 11. This role plays a key part in audit preparedness, deviation management, and maintaining consistent quality across IT operations and projects. Key Responsibilities: Develop, implement, and maintain IT quality policies, SOPs, and work instructions in accordance with QMS. Ensure compliance of IT systems with relevant regulatory requirements (GxP, 21 CFR Part 11, GDPR, e...