245 Deviation Jobs - Page 7

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...

Monitor all in-process manufacturing and packaging activities on the shop floor. Perform line clearance before manufacturing/packaging starts. Verify batch records and ensure adherence to SOPs and BMR/BPR entries. Check critical control points and parameters during manufacturing. Review batch manufacturing records (BMR), batch packaging records (BPR), and logbooks in real time. Ensure timely and accurate documentation of in-process observations. Escalate any deviation or non-conformance observed during the process. Ensure compliance with cGMP, GDP, and regulatory requirements. Assist in handling deviations, change controls, and CAPAs. Participate in internal audits and regulatory inspections...

Supervise and coordinate QA lab personnel and activities related to sampling, testing, and reporting of raw materials, in-process samples, and finished products. Ensure compliance with Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), and regulatory guidelines (e.g., FDA, ISO, ICH, etc.). Review and approve analytical test results, COAs (Certificates of Analysis), and related documentation. Manage calibration, maintenance, and validation of laboratory instruments (e.g., HPLC, GC, UV-Vis, FTIR). Investigate out-of-specification (OOS), out-of-trend (OOT), and non-conformances; participate in root cause analysis and CAPA implementation. Ensure timely completion of stability s...

1. Utilize a broad understanding of cGMP to provide QA support, mentoring and coaching for Operations, Analytical, Logistics and Engineering departments to assure that activities are undertaken in compliance with cGMP and procedures, as appropriate. Required Candidate profile GMP PRO/DATA NIJNA/BMR/ANNUAL PRODUCT REVIEW/MBR/CLEANING VALIDATION

Role & responsibilities Job Description: 1. Preparing and implementing of standard operating Procedures, Batch records, Protocols, cleaning procedures and relevant log sheets. 2. Maintaining documents as per regulatory and cGMP norms. 3. Handling of QMS activities, Change controls, Deviations, Incidents and risk assessments. 4. Responsible for ensuring the department employees for training as per training plan schedule in the TRIMS. 5. Responsible to attend all training programs, SOPs and cGMP trainings relevant to area and equipments. 6. Responsible for monitoring of periodic review of SOP’s related to FP Departments and ensuring the completion with in due date. 7. Performing DQ, IQ, OQ, an...

Must have minimum 4 years experience in QMS activity Issuance and management of QMS Forms (e.g., CC, CAPA, Deviation, etc.) Participate in the evaluation and investigation of quality-related issues Coordinate with cross-functional teams (CFT) and relevant stakeholders for issue resolution Review and compile supporting documents for QMS processes Maintain and update QMS log registers Ensure proper documentation and records management of QMS activities Perform artwork review to ensure compliance with quality standards Job Location: Kadi, Gujarat ( Bus facility available from Ahmedabad, Kalol & Kadi) Note: Immediate joiners will be preferred first

Experience in pharma regulatory & QMS function, primarily in RLD / comparator sourcing, clinical trial supply chain management, and clinical packaging for USA and EU markets. The role includes supporting the end QMS function and regulatory affairs. Health insurance Provident fund Annual bonus

Change Control & CAPA Management Initiation and documentation of Change Controls and CAPAs related to: SOP revisions Equipment qualification and modifications Deviations, self-inspections, and facility changes

Role & responsibilities : Responsible for following activities: Handling of Change controls, Deviations, Market complaints, CAPA and other QMS Documents. Participate in investigation of Nonconformities. Participate in quality risk management and maintain its record. Preparation and review of Product Quality Review Report (APQR). To execute product recall and mock recall activities. To coordinate for management quality review meeting. Handling of internal audit activities and compliance with CAPA. Preparation and review of SOPs, SMF, Quality Manual Preferred candidate profile ERP/ QMS software system handling experience

Receive and Log Complaints : Record and evaluate complaint submissions from customers regarding manufacturing defects or issues. Ensure all complaints are logged accurately in the complaint management system. Investigate Complaints : Conduct thorough investigations to determine the root cause of the complaint. Coordinate with internal departments (Quality Assurance, Regulatory Affairs, Production) to gather necessary information. Communicate with Stakeholders : Communicate with customers to understand their concerns and provide updates on the investigation. Liaise with healthcare providers, if applicable, to acquire relevant complaint information. Regulatory Compliance : Ensure timely proces...

About Intas Recruitment Fraud Disclaimer: Intas Pharmaceuticals does not request or accept any fees during recruitment If someone asks for payment on our behalf, it is a scam Please report the incident to the local police or cybercrime unit Your trust and safety are important to us, Intas is a leading global pharmaceutical company specializing in the development, manufacturing, and marketing of pharmaceutical formulations The mission of the company is to address unmet medical and societal needs through a fully integrated pharmaceutical value chain spanning across the world, Through its subsidiaries, the International presence of Intas includes the following countries: over 85 worldwide, with...

About Intas Recruitment Fraud Disclaimer: Intas Pharmaceuticals does not request or accept any fees during recruitment If someone asks for payment on our behalf, it is a scam Please report the incident to the local police or cybercrime unit Your trust and safety are important to us, Intas is a leading global pharmaceutical company specializing in the development, manufacturing, and marketing of pharmaceutical formulations The mission of the company is to address unmet medical and societal needs through a fully integrated pharmaceutical value chain spanning across the world, Through its subsidiaries, the International presence of Intas includes the following countries: over 85 worldwide, with...

Role & responsibilities Lead the vendor qualification process, including the evaluation and approval of new and existing vendors. Review and approve vendor documentation to ensure compliance with internal standards and regulatory requirements. Manage QMS notifications, ensuring timely resolution of issues related to change control, deviations, and CAPA. Oversee the preparation, review, and approval of SOPs to ensure alignment with current practices and regulatory standards. Conduct comprehensive risk assessments and risk analysis to identify potential quality issues and implement mitigation strategies. Independently plan, conduct, and report on vendor audits, coordinating with internal and e...

Job Role: Overall responsibility of quality assurance & food safety for Snacks category (includes Potato Chips, Extruded & Fried Snacks, Traditional namkeens, Sweets and similar products) manufactured at third-party locations and/or RCPL sites, successful implementation of RCPL quality systems, setting up monitoring & testing protocol for various quality parameters, third-party mfg. locations audits, training and driving quality culture. Key Responsibilities: 1. Compliance with RCPL Quality Standards: • Develop & communicate RCPL Quality Standards & Technical-manuals for SNACKS category • Implement & maintain RCPL quality standards & processes at 3P locations • Ensure incoming RM/PM or ingre...

Job Description 1. Preparation of SOPs of QA, review of other departments' SOPs, 2. To perform batch release of API material and review of related documents. 3. To prepare and review Quality Risk Assessment, Site Master File, Hold Time Study Protocol/Reports, and other study protocols/reports, Specifications, Stability Protocol, and Stability Report Data. 4. Review of Validation Master Plan. 5. To review the analytical method transfer protocol/report and method validation documents of the API. 6. To ensure and handle the investigation of out-of-specification Results, OOT, Deviations, Product failures, and Market Complaints. 7. To review Quality system documents such as Deviation, Change cont...

Position Assistant Manager-QA Function QA Location Bharuch;;;;;;; Reports to Head QA Summary of Job (Purpose/ objective of the job Department organogram to be enclosed) To check the Quality Assurance of the products and ensure compliance with the SOP's. Key Responsibilities (Performance Indicators) Quality professional of progressive experience with strong knowledge of Speciality Ingredient, Bulk Chemicals, Food additive/ Food supplement and API Manufacturing, Quality Management System (QMS), Qualification, Validation and other Manufacturing functions.; Documentation and Handling i.e.: Integrated Management System (IMS) (ISO 9001:2015, ISO 14001:2015 and ISO 45001:2018), WHO-GMP, FSMS (ISO 2...