161 Deviation Jobs - Page 4

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 all kinds of losses. • Coach colleagues on operational excellence tools and drive projects for capacity improvements. • Regularly update data in management information systems (MIS). • Analyze data available in the production system and take appropriate action. • Conduct TPM (Total Productive Maintenance) and continuous improvement meetings regularly. • Develop subject matter expertise for internal and external audits. • Identify compliance and operational discrepancies through regular Gemba walks. • Understand OEE (Overall Equipment Effectiveness), Lean, and Six Sigma methodologies.

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 BPCR as per procedure. 11) To be issue BPCR to all blocks as per prerequisite. 14) To be handle change control, market complaint, deviations, CAPA. 15) To be issue documents, protocols, log book and format to all department as per prerequisite. 16) Retrieval of documents. 17) To be controlled all master documents. 18) To be prepared schedule & conduct Internal audit. 19) To be prepared APQR of all products. 20) Preparation of documents for Certification & product registrations work i.e. FDA, Halal, Kosher, Reach. etc. Review specification, test procedure and SOP's for their deficiencies according to audit points 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 senior’s guidance. 5) To be prepare cleaning validation protocol and report as per senior’s guidance. 6) To be conduct training and evaluation done as per Schedule. 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 BPCR as per procedure. 11) To be issue BPCR to all blocks as per prerequisite. 13) To be prepared data for monthly report as per QMS and submit to senior. 14) To be handle change control, market complaint, deviations, CAPA. 15) To be issue documents, protocols, log book and format to all department as per prerequisite. 16) Retrieval of documents. 18) To be prepared schedule & conduct Internal audit. 19) To be prepared APQR of all products.

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 oversight. Supporting the continuous improvement and operational success of the quality assurance function. Perform the assigned activities given by them as defined in the SOP Ensure that QA practices and deliverables comply with regulatory requirements and industry standards. Oversee the planning, execution, and documentation of all QA activities, including functional testing, regression testing, performance testing, and validation testing. Collaborate with development teams to identify and resolve defects and ensure the timely delivery of high-quality software releases. Collaborate with stakeholders to develop validation plans and protocols, including but not limited to Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and User Acceptance Testing (UAT). Prepare and maintain validation documentation, including validation plans, protocols, reports, and traceability matrices, in compliance with regulatory requirements and internal procedures. In-depth knowledge of regulatory requirements and guidelines governing CSV, including FDA regulations (21 CFR Part 11, 21 CFR Part 210/211), GxP, GAMP, Annex 11, and other relevant standards (e.g., ISO 27001, ISO 9001). Strong analytical and problem-solving skills, with the ability to interpret and apply regulatory requirements to validation activities and systems. Qualifications: Strong understanding of quality assurance processes and regulatory requirements. Excellent analytical and communication skills. Ability to work collaboratively within a team and manage tasks effectively. understanding QA terminologies, exposure to any QMS database will be of added advantage

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) Preparation & Review of Quality Assurance SOPs. 9) Review other Department SOPs. 10) Review of Executed BMR/BPR. 11) Participation in investigation of failures. 12) Participation in aseptic process simulation, cleaning validation and review of related documents and visual observations of Media fill vials. 13) In-process Quality Assurance during production activity and sampling at different stages of processing / packing as per requirement. 14) Monitoring and review of Quality system documents such as Deviation, Change control, OOS, OOT and CAPA. 15) Review of Master documents such as e-BPR, filter validation documents. 16) Review of stability study protocol and stability study reports Work Experience 5-6 years Education Graduation in Pharmacy Competencies

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 Audit Reediness if interested please share your resumes to jayakishore.gollapalli@srikrishnapharma.com

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 manufacturing of stainless steel seamless tubes. Stay updated on industry trends, new technologies, and best practices related to the Pilgering process and stainless steel tube production. Maintain detailed records of production processes, including process parameters, test results, and any deviations from the standard.

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 process for cleaning of equipment as per the schedules. 4. Responsible for housekeeping and implementation of day to day cleaning of process area & clean room. 5. Preparation, review and approval of monthly Reports and BPRs BCRs, OOS, Deviation, investigations reports, validation protocols reports, validation reports. 6. Responsible for preparation of daily production planning and ensuring the same. 7. Production planning, ensuring that the batches are produced as per planning and meeting the dispatch targets. 8. Ensure proper utilization of equipment and manpower as and when required 9. Planning and monitoring during execution of the process validation. 10. Manpower planning. Monitor the project modification activities. 11. Responsible to handle production processes as per BPR and cleaning as per BCR. 12. Responsible for reviewing of LFR/LDR, development report coordination with group leader, TSD, EHS & QA. 13. Responsible for reviewing the completed BPR’s in line with GMP guideline before handover to QA. 14. Responsible for responding the client review comment in BPR and others GMP related documents. 15. Allocating equipment to maintenance department as per preventive maintenance schedule. 16. Responsible to monitor all instruments such as temperature indicators, pressure gauges and their calibrations according to schedules. 17. Responsible to co-ordinate with QC for in- process/ intermediate /finished product sample results. 18. Conducting & participating the training programmes related to production operations, GMP and safety. Technical / Functional 1. Manufacturing-Production. 2. Compliance. 3. Validation. 4. Process scale up. 5. Technology Transfer. 6. Capacity enhancement. 7. PROCESS Safety management – Implementation 8. Cost reduction /Launching of new products. 9. Lean Manufacturing. 10. Expansion project.

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/BPRs (Batch Production Records) as per regulatory standards. Coordinate with QA, QC, maintenance, and warehouse departments to ensure smooth workflow. Support validation activities, including equipment qualification and process validation.

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. Maintain proper documentation for all packing activities and related records. Work closely with production, quality control, and warehouse teams to ensure timely production schedules are met. Assist with training new staff on packing procedures and equipment. Participate in ongoing training to improve packing processes and stay current with industry best practices. Identify opportunities for process optimization and work with management to implement improvements.

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 and QMS Training presentation and circulating training links to all employees based on training schedules and follow ups. 4. Review of Risk assessments related to change control, CAPA, Deviation, OOS, OOT. 5. Review of Analyst Qualifications and review of Analytical LNBs. 6. Review of Vendor Questionnaires and Review of Vendor qualification documents and checking external facility and vendor audits with respect to raw materials and finished products. 7. Review of new GMP projects with regard to regulatory and client compliance aspects, Scrutiny of GMP facilities and Review of GMP Certifications & all requirements applicable to the projects. 8. Review of SOPs, Specifications, Method of Analysis and Analytical test data sheet. 9. Review of Method transfer protocols and reports, Validation protocols and reports, Forced degradation data and Review of quality impacting incidents, OOS and Data corrections. 10. Lab rounds and Compliance verification and Qualification of GMP Contract Manufacturing Facilities (CMO). a. Circulation of Non-compliances b. Circulation of Non-Compliance reports to CMO 11. Circulating agenda for Internal Audits and Management review meetings, Reporting & Circulation of Non-Compliances and Suggestion of appropriate CAPAs. 12. Functional Objectives: Follow-up & review of the objectives action plan and Data collection & compilation. 13. Review of weekly and monthly reports and collecting data. 14. Monitoring of QMS activities as per ISO & Client requirements. 15. Document issuance, retrieval and archival, document control. 16. During the audits, to coordinate with the with the auditors to show and explain the documentation of quality systems & procedures. 17. Preparation quality system procedures and quality manual. 18. To prepare audit compliance reports or responses and to ensuring the successful closure of audit cycle. Interested candidates can attend walk-in drive or share their profiles to saivardhan.kothuri@chemvedals.com

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 maintained within specified limits. Train and guide operators and junior staff in GMP practices and SOP adherence. Investigate deviations and support in root cause analysis and implementation of CAPA. Ensure compliance with EHS (Environment, Health, and Safety) standards within the manufacturing area.

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, etc.). Collaborate with QA, Validation, and Business teams for development, qualification, and maintenance of IT systems as per CSV and QMS guidelines. Manage QMS elements such as deviations, CAPAs, change controls, audit trails, and periodic reviews. Participate in internal/external audits; coordinate documentation, evidence, and responses. Conduct IT quality risk assessments and support necessary remediation. Maintain accurate records of compliance activities, including SOP training and validation documentation. Deliver training programs to IT teams on QMS processes and compliance awareness. Support full lifecycle management of computerized systems (planning, validation, operation, retirement). Assist with vendor qualification and assessments for IT-related services. Required Skills and Qualifications: 3 - 5 years in IT compliance/QA/validation in a regulated industry Working knowledge of ISO 9001, GAMP 5, 21 CFR Part 11, EU Annex 11 Familiar with LIMS, ERP, MES, DMS systems Strong documentation and analytical skills Good understanding of ALCOA+ and data integrity Preferred Certifications: ISO Lead Auditor, Six Sigma, or other Quality Management certifications

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. Verify the status and calibration of equipment before use. Ensure proper labeling, handling, and storage of materials.

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 studies and trending of data.

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, and PQ for the equipment’s. 8. Writing of relevant Batch documents and log books. 9. Execution of production plan for formulation and filling. 10. Achieving planned FP targets with strict adherence to cGMP. 11. Execution of planned activities of Aseptic Processing Areas like media fills simulation trials, Formulation and filling activities. 12. Execution of preventive maintenance plan for equipment’s in coordination with Engineering and QA departments. 13. Performing day to day activities as per requirements. 14. Reporting all the activities, deviations and issues to Reporting officer. Preferred candidate profile ITI/ DIPLOMA/ B. TECH/ Pharmacy With Relevant experience

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