253 Cleaning Validation Jobs - Page 2

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...

Sr. Executive / Executive based in Kadi, Mehsana District, Gujarat. The ideal candidate brings 5 to 8 years and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments. Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety. The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Le...

Sr. Executive / Executive based in Kadi, Mehsana District, Gujarat The ideal candidate brings 5 to 8 years and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Lean/...

Senior Executive QA 1 Post based in Kathua, Jammu & Kashmir The ideal candidate brings 8-10 Years and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Lean/Kaizen) S...

Sr. Executive / Executive based in Kadi, Mehsana District, Gujarat. The ideal candidate brings 5-8 Years and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments. Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety. The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Lean/...

Role & responsibilities Monitoring and continuously up keeping food safety and hygiene standards of the kitchen Giving training to the kitchen team on various SOPs, quality and food safety standards Prepping kitchen to comply to FSSAI standards and other internal audits Proactively checking the quality of raw ingredients/products through sensory and its documentation Handling customer complaints by doing RCA and sharing CAPA Analyzing data to understand regional performance on various metrics Ready to travel to different locations of the city Key Competencies Good communication skills Good understanding of the domain of food safety, RCA & CAPA , quality standards Well versed with FSSAI regul...

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. 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...

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...

Quality Risk Management Batch Manufacturing Record preparation Process Validation Annual Product Quality Review Cleaning Validation Batch card preparation Dossier Preparation Change Control Management Documents preparation New Drug Application Required Candidate profile Experience in Quality Assurance in Pharma Industry Gender Female Location South Kolkata

As a Blister Filling Machine Operator in the Injectables Division of the Production Packaging department at our company, you will play a crucial role in ensuring the efficient operation of blister packing machines. Your responsibilities will include: - Operating and monitoring blister packing machines following SOPs and GMP guidelines. - Performing machine setup, changeovers, and basic troubleshooting. - Ensuring proper feeding, sealing, and packing of ampoules/vials in blister packs. - Monitoring printing, batch coding, labeling, and packaging integrity. - Maintaining machine hygiene and conducting cleaning validation. - Conducting in-process checks to ensure sealing, batch coding, and pack...

As an Officer/Executive in the Quality Assurance Department at a company located in Bavla, Ahmedabad, your role will involve the following responsibilities: **Role Overview:** You will be responsible for Process Validation and Qualification activities in the pharmaceutical manufacturing industry. **Key Responsibilities:** - Prepare standard operating procedures for various processes - Issue controlled formats to the concerned departments - Provide necessary documents for regulatory dossier submissions - Prepare protocols for Process Validation, cleaning validation, and hold time validation studies - Execute process validation, hold time validation, and cleaning validation activities - Review...

Quality Risk Management Batch Manufacturing Record preparation Process Validation Annual Product Quality Review Cleaning Validation Batch card preparation Dossier Preparation Change Control Management Documents preparation New Drug Application Required Candidate profile Experience in Quality Assurance in Pharma Industry Gender Female Location South Kolkata

About Apotex Inc. Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions. For more information visit: www.apotex.com . Job Summary The position entitles the incumbent to possess adequate practical and technica...

The opportunity Senior will play a critical role in managing a team. Work closely with clients of People Advisory Services within and outside EY Your key responsibilities Responsible for executing, quality control and reporting daily status to the internal leadership team as well as to our user groups Responsible for meeting contractual SLA's Will be the first point of escalation Adhere to practice protocols and other internal processes consistently Be an integral part of the Global and/or Local Client Service Delivery team Conduct complete review of client deliverables for quality assurance and ensure the team has adhered to the process protocols. Handle escalations effectively Develop a hi...

Role & responsibilities : We are looking for multiple positions from IPQA to QMS aspects, experienced between 2 years to 12 years in OSD formulation QA with B.Pharma/M.Pharma background. Preferred candidate profile : candidates having exposures on IPQA, line clearance, BMR BPR Review, CAPA management, Market compliant investigation, Change control, validations and qualification, vendor management and audit compliances.

Role & responsibilities Monitoring and continuously up keeping food safety and hygiene standards of the kitchen Giving training to the kitchen team on various SOPs, quality and food safety standards Prepping kitchen to comply to FSSAI standards and other internal audits Proactively checking the quality of raw ingredients/products through sensory and its documentation Handling customer complaints by doing RCA and sharing CAPA Analyzing data to understand regional performance on various metrics Ready to travel to different locations of the city Key Competencies Good communication skills Good understanding of the domain of food safety, RCA & CAPA , quality standards Well versed with FSSAI regul...

Line Clearance for Dispensing, Manufacturing & Packing activities Dispensing of RM/PM for batch Mfg Monitoring of IPQA activities (Granulation, Blending, Capsulation, Compression, Coating, Packing Sampling of IP and FP Samples Batch documents review

Job Description: Require experience in IPQA, IPQA (API), Qualification (API), Validation (API), Analytical QA, APQR, Stability Studies, regulatory affairs, OOS investigation, Risk Assessment, Market Complaint, QA Documentation, Exposure in QMS, Deviation, CAPA etc with Trackwise system. Qualification - B.Sc./M.Sc./ B.Pharma/ M.Pharma. Experience - 04 to 09 Years. Role & responsibilities Preferred candidate profile The candidate from API background Only to apply. Send CV with Sub : Forwarding CV for position of QA dept to jagpal.dewal@ipca.com

Urgent Hiring || Quality Assurance Officer || Mumbai Profile : Quality Assurance Officer Experience : Min 3 years CTC : upto 4 LPA (Depend on the interview) Location : Tajola Mumbai Roles and Responsibilities: Issuance of all documents related to QMS, BMR, ECR, Specification, MOA, TDS, formats & SOPs controlled copy. Preparation, review and distribution of SOPs Review Batch manufacturing Record (BMR), Equipment cleaning record (ECR) etc. Handling of Change Control Systems, out of specification, deviations etc. Preparation of Annual product quality review. Preparation & monitoring of process validation activity. Preparation & Monitoring of Cleaning validation activity. Handling of pre - dispa...

Role & responsibilities 1. Responsible for monitoring of basic norms of cGMP, ALCOA+ Principle, data integrity, GDP & to maintain his personal health hygiene. 2. To co-ordinate and carry out the self inspection and maintain records of self inspection report, schedule, auditor List, Auditor Qualification, compliance status etc. 3. To prepare, review and implement various protocol and report like Process Validation, Cleaning validation, HVAC validation, Temperature Mapping (Area / Equipment), Equipment / Instrument / System Qualification, Hold time Study. 4. To execute various activity like Process Validation, Cleaning validation, HVAC validation, Temperature Mapping (Area/Equipment), Equipmen...

Sr. Executive / Executive based in Kadi, Mehsana District, Gujarat. The ideal candidate brings 5 to 8 years and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments. Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety. The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Le...

Sr. Executive / Executive based in Kadi, Mehsana District, Gujarat The ideal candidate brings 5 to 8 years and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Lean/...