250 Cleaning Validation Jobs

As an experienced and dynamic professional in the pharmaceutical industry, you have the opportunity to join Ananta Medicare Ltd in Sri Ganganagar, Rajasthan, specifically in the Quality Assurance Department for Validation activities in a manufacturing facility. Your role will involve hands-on experience in qualification and validation activities for a sterile / Cepha manufacturing setup. Key Responsibilities: - Execution and review of Qualification activities for Equipment, Utilities, and Facilities (URS, DQ, IQ, OQ, PQ). - Preparation and review of validation protocols and reports (Process Validation, Cleaning Validation, Sterilization Validation, HVAC Qualification, etc.). - Coordination w...

1. To prepare annual equipment qualification planner with respect to validationmaster plan. 2. To prepare HVAC / compressed air / effectiveness of cleaning validation planner. 3. Preparation of protocols for qualifications of newly procured equipments and ofequipments transferred from other location. 4. Preparation of protocols for re-qualifications of HVAC system. 5. Preparation and execution of re-qualification protocols and reports as per schedule ofvalidation master plan and as on when required. 6. Toperform cleaning validation cleaning verification. 7. Preparationreview of cleaning assessment report. 8. Preparation review of process validation protocols and reports. 9. Preparation revie...

Issuance of Analytical Data Sheets and Formats. Preparation and Review of specification and standard test procedure. Review of QC Analytical Data. To ensure online documentation in laboratory as Good Documentation Practices. To attend training as per refresher training schedule. To ensure all time audit readiness in the work area. To perform any other work as and when assigned by Head of department.

1. Line clearance in dispensing, manufacturing and packing area 2. In -Process Quality Assurance activities, sampling, analysis and AQL during production. 3. To ensure stage wise completeness of BMR during production. 4. Monitoring of environmental conditions in production area. 5. Coordination with other departments for smooth running of the plant. 6. Calibration, verification and maintenance of IPQA instruments. 7. To monitor process as per technical directions. 8. To fill all IPQA sampling logs in time. 9. To ensure deviations are properly documented and CAPA implemented. 10. To withdraw samples at different stages of In-Process and finished product as well as validation samples as per TD...

Dr. Reddy's Laboratories Ltd. is a leading multinational pharmaceutical company based across global locations. Each of our 24,000 plus employees comes to work every day for one collective purpose: to accelerate access to affordable and innovative medicines because Good Health Can't Wait . We started in 1984 with a modest investment, 20 employees and a bold vision. Today, we have research and development centres, manufacturing facilities or a commercial presence in 66 countries. For nearly four decades, we have stood for access, affordability and innovation based on the bedrock of deep science, progressive people practices and robust corporate governance. As the pharmaceutical industry evolve...

Preference to Immediate Joiner Company: Ananta Medicare Ltd, Sri Ganganagar, Rajasthan Ananta Medicare Ltd is looking for an experienced and dynamic professional to join our Quality Assurance Department for Validation activities in a manufacturing facility with hands-on experience in qualification and validation activities for a sterile / Cepha manufacturing setup. Key Responsibilities: Execution and review of Qualification activities for Equipment, Utilities, and Facilities (URS, DQ, IQ, OQ, PQ). Preparation and review of validation protocols and reports (Process Validation, Cleaning Validation, Sterilization Validation, HVAC Qualification, etc.). Coordination with Production, QC, and Engin...

Co-ordination & Ensuring timely execution of Sampling activity of Raw and Packing materials. Preparation, Review and updating of standard operating procedure. To ensure line clearance for dispensing, sampling and packing activity. Routine monitoring of all functional area to ensure adherence to the SOPs. Create signature and methods for raw materials by using Truscan RM analyzer. Approved / Rejected labels affixing for API, Excipients, Primary packing and secondary packing materials finished goods and operation supplies. Verification of Temperature and Relative Humidity reports generated from TESTO software. To perform the QMS (change control) activities as per access approvals. To perform n...

experience in Vaccine or Biosimilar manufacturing Strong exposure to In-Process Quality Assurance & Quality Management Systems and review system Knowledge of GMP guidelines and documentation practices fast-paced, regulated environment Perks and benefits 5- days working, Pf , health insurance

protocol & reports of equipment / utility qualification Responsible for execution of equipment / utility qualification. process validation cleaning validation Annual Product review Validation Master Plan. Computer System Validation/ PLC validation Perks and benefits Food & Transportation, Bonus & Gratuity Separately

Job Title: Officer -QA Business Unit: Global Quality And Compliance Job Grade G12C Location : Gangtok At Sun Pharma, we commit to helping you “Create your own sunshine” — by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine? As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.” Key responsibilities: To give the line clearance as per BMR/BPR...

Role & responsibilities To ensure cGMP Compliance as per laid down procedures. Monitoring overall all QA activities - Process validation, Cleaning Validation, Equipment Qualification and Master Document review. Preparation and review of SOPs applicable to QA. Evaluation of QMS documents. Preparation of Validation Master Plan, review of process validation, equipment qualification and cleaning validation protocols and reports Participate in investigations and review of investigations. Monitoring of Exhibit and Submission batches documentation and Coordination with RA for document submission Monitoring of document control, storage, and archival. To provide training to QA team members and other ...

Job Description Preparation and updation of Validation Master Plan (VMP) Preparation of Process validation, Computer system validation protocol and report. Preparation of product matrix and Cleaning Validation/verification protocol and Report. Preparation of qualification and requalification protocol and report for processing equipment/instrument, utilities, and facility. Preparation of area validation protocol and reports. Preparation and review of quality risk assessments. Review of calibration certificate (External/internal). Preparation, issuance, review & archival of BMR/BPR. Batch Record storage, retrieval & destruction. Preparation of APQR. Line Clearance for Manufacturing, Packing & ...

Role & responsibilities 1 Preparation of standard operating procedure. 2 Preparation of quality documents. 3 Initiate / review of change control system. 4 Initiate / review of deviation. 5 Initiate / review of CAPA. 6 To control, issue, retrieve, retention and disposal of GMP documents as per standard procedure. 7 Review of MFR/BMR/BPR/ECR. 8 Review of validation protocols and report. 9 To participate in investigation of OOS for RM/intermediate/FP. 10 To participate in market complaint handling. 11 Review of vendor qualification documents. 12 Review of executed manufacturing and analytical records. 13 Preparation of annual product quality review. 14 To take plant round and ensure compliance ...

1. Quality Systems & Documentation: Develop, implement, and maintain GMP-compliant QMS. Oversee change control, deviations, CAPA, incident management, risk assessment, and market complaints. Ensure GDP compliance in all QA documentation, including SOPs, batch records, specifications, and MOAs. Prepare and revise SOPs, distribute and retrieve old versions, and manage documentation control. Handle QMS activities like return goods, non-conformities, and investigation reports (5-Why, 6M method). 2. Validation & Qualification: Review and approve URS, IQ, DQ, OQ, and PQ protocols and reports. Manage process validation, cleaning validation, equipment qualification, and facility validation. Conduct ...

Core Purpose of the Role: Experience - 8 to 10 years Line Clearance process overview, Product change over. Timely area readiness (Cleaning, EMS, OOS status) and ensures availability of documents and material status. Monitoring of process through process step verification. Reviewal of Batch Manufacturing Record to check compliance from stepwise process execution till written instructions. Equipment / utility Qualifications, Calibrations, PM verification. Utility / Computer system validation Process validation and cleaning validation. Target Monitoring for batch related process activities. cGMP compliance and verification overview of BMP facility & Utilities. SOP preparation and review. Traini...

Responsibilities: Monitor manufacturing and packaging processes, including line clearance and in-process checks (IPQA) Manage documentation activities, including DOC-QMS systems, SOP preparation, deviation handling, and change control Support Technology Transfer (TT) activities by reviewing protocols, executing processes, and coordinating between R&D and manufacturing teams Ensure compliance with 21 CFR Part 11 requirements through validated software systems for electronic records and signatures Execute equipment qualification (DQ, IQ, OQ, PQ), process validation, and cleaning validation activities Utilize automated quality systems and digital platforms for manufacturing documentation Mainta...

Responsibilities: Review and approve batch records, laboratory data, and other relevant documents related to the manufacturing process. Ensure all operations comply with GMP guidelines and internal quality standards. Conduct internal audits to assess adherence to GMP, standard operating procedures (SOPs), and other regulatory requirements. Participate in the review and approval of finished product batch records and assist in product release processes. Investigate and manage deviations, CAPAs (Corrective and Preventive Actions), and OOS (Out of Specification) results in a timely manner. Support the quality control laboratory in ensuring that all testing is performed in accordance with regulat...

Responsibilities: Ensuring Compliances: Quality Assurance professionals play an important role in ensuring that all processes & product comply with QMS/IMS and other relevant regulations. Quality Control: Quality Assurance professionals involved in the development, maintenance & implementation of procedures and system in QC and production. Documentation: QA professionals review and approve documents such as SOPs, batch record & other quality related documents. Audits & inspections: They conduct audits & inspections to ensure compliances with regulations & identify areas for improvements. Investigation & Corrective Action: They investigate deviations or non-conformance & implement corrective ...

Roles and Responsibilities Conduct Process Validation, Equipment Qualification, and Cleaning Validation activities according to SOPs. Prepare documents for Capa, MACO, OSD, and SOP preparation. Ensure compliance with regulatory requirements through quality control measures. Collaborate with cross-functional teams to resolve quality issues. Maintain accurate records of all quality-related activities. Desired Candidate Profile 5-10 years of experience in Quality Assurance (QA) or related field. Bachelor's degree in Pharmacy (B.Pharma) or Master's degree in Pharmacy (M.Pharma). Strong understanding of pharmaceutical industry regulations and standards. Proficiency in equipment qualification, cle...

Department Quality Assurance Section Documentation Designation Deputy Manager Qualification M.Pharmacy / B.Pharmacy EXP Required 12 Years Reporting to Sr. Manager Sr. No. Responsibility Responsible for Preparation, Review of Process Validation, Cleaning validation protocol & reports. 2 Responsible for Execution of Process Validation, cleaning validation activity. 3 Responsible for Preparation. Review of hold time study protocol & reports, Execution of hold time study against planner. 4 Responsible for Preparation of Standard operating procedure. 5 Responsible to provide Personal training. 6 To ensure complete documentation, control and retention of validation documents against activity done....

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 Summary: The Production Shift In-Charge DSP is responsible for leading all downstream processing operations during the assigned shift to ensure consistent, efficient, and GMP-compliant production of biological products (e.g., monoclonal antibodies, vaccines, recombinant proteins). The role involves supervising the purification process, managing manpower, ensuring equipment readiness, and maintaining quality and safety standards. Role & responsibilities Key Responsibilities: 1. Shift Operations Management Supervise all downstream production activities, including harvest, filtration, chromatography, ultrafiltration/diafiltration (UF/DF), and formulation. Ensure batch manufacturing records ...

Job Title: Manager - Regulatory Affairs / Quality Assurance Company: GreenSignal Bio Pharma Pvt Ltd Location: Gummidipoondi, Chennai, Tamil Nadu Experience: 10-15 years in Quality Assurance and Regulatory Affairs, specifically within the Vaccine, Injectable, and Sterile Industry Educational Qualification: Bachelors or Masters in Pharmacy M.Sc in Biotechnology, Microbiology, or a related field Additional qualifications in life sciences or pharmaceutical sciences are a plus Job Overview: As the Manager QA / Regulatory Affairs , you will play a pivotal role in ensuring that our vaccine , injectable , and sterile pharmaceutical products meet global regulatory requirements and quality assurance (...

Role & responsibilities: Preparation and review of SOP. Preparation and monitoring of change control, deviation control. Review and approve the Standard Operation Procedure, Product Quality Reporting System (PQRS), Change control, Deviation controls/Analytical Protocols/Stability protocols/Qualification and validation protocols and reports. In-Process checking during online activities. To ensure timely submission of audit compliances for the deficiency during the inspections/audits Monitoring of GMP compliance. Review of quality documents and analytical data as per pharmacopeia specification, STP, batch card, stability finish product, packaging materials for the purpose of compilation of dos...

Job Description -Review and authorize Master Batch Records, stability protocol, process validation protocol, temperature cycling protocol, specification of in-process, intermediate and finished products for US and IRF market at CMU. -Release of batch manufactured for US and IRF market at CMU -Handling of market complaint with root cause identification and CAPA implementation -Review of documents such as executed BPR, Analytical records, Change Controls, Deviations, OOS, Process Validation, Cleaning Validation, Equipment Qualification, stability data and CAPA for products of US & IRF market. -Provide required documents to Regulatory affairs for variations and updates -Monitoring of process st...