80 Cleaning Validation Jobs - Page 2

Witnessing of manufacturing processes for sterile drug products including cleaning, sanitization, environmental monitoring and personnel monitoring to ensure compliance with CGMP regulations and regulatory standards Oversight of cleanroom behavior, contamination control and aseptic techniques To report any observations to site operations and quality and ensure compliance to the observations Review of media fill protocol and reports and witnessing aseptic process simulations Review of batch documentation to ensure product quality, regulatory compliance and meeting ALCOA++ requirements Review of environmental monitoring reports Review of unplanned deviations and CAPA

Witnessing of manufacturing process (mixing, granulation, blending, compression, coating, capsule filling) & packing (primary/secondary packaging) for solid oral products to ensure compliance with current Good Manufacturing Practices (cGMP) and regulatory expectations. Oversight of line clearance, equipment and area cleanliness, material verification, and adherence to SOPs. Ensure compliance with data integrity (ALCOA++) standards in all documentation and records related to production and QA oversight. Review of batch documentation to ensure product quality and regulatory compliance. Review of unplanned deviations and CAPA. Review of environmental monitoring data Collaborate with site operations and quality functions to report and ensure resolution of non-conformances or compliance gaps.

Long Description Role- Shift Officer - MDI Manufacturing To Supervise compliance to all CGMP or any other regulatory requirements, including EH&S requirements. Complete self-training and monitor training of team members on relevant SOP. Report any quality concerns or suggestion for improvements SOPs. Execute and supervise all tasks and activities as per the applicable SOPs. Supervision of operations, cleaning and maintenance of MDI process equipment's / area in MDI Production area of unit-3. Planning, execution, monitoring supervision of all unit operation for batch processing and Manufacturing. Co-ordination with cross-functional teams for smooth execution of production plan at shop floor. To ensure documentation of required process parameter as per SOPs. Training and development of subordinates to ensure functioning at shop floor as per cGMP requirements. To ensure status labelling of equipment, machines, area and instruments comply with the requirements. In-process checks during stage wise process as per Batch Manufacturing Record as per Standard Operating Procedure. Gap analysis of defined procedures in BMR / SOP / Protocol and initiation of corrective action. Handling of Quality Management Documents like change control, deviation, CAPA and other related documents. To ensure required inventory of approved consumables in Warehouse. To report of incident, non-conformity immediately to the manager. Competencies Developing Talent Innovation & Creativity Result Orientation Strategic Agility Process Excellence Customer Centricity Collaboration Stakeholder Management Education Work Experience

As the Quality Management Systems (QMS) Manager at our corporate departments, you will play a vital role in ensuring the highest standards of quality across all aspects of our operations. Your responsibilities will include reviewing, approving, and closing change controls, deviations, and incidents for the corporate department. Additionally, you will be tasked with reviewing change controls for oral dosage forms across all Hetero formulations facilities. Your role will also involve reviewing Process Validations, Continued Process Verification, Cleaning Validations, Hold time studies, and Annual Product Quality Reviews (APQR) across our formulations facilities. You will be responsible for coordinating and overseeing Quality review meetings, as well as implementing and harmonizing the Quality Management system across all oral dosage form facilities. In this position, you will be in charge of issuing and controlling Critical Quality Attribute (CQA) Standard Operating Procedures (SOPs) for the respective formulation units. You will provide support for regulatory inspections in all formulation units within the Hetero group and conduct self-inspections to ensure compliance with quality standards. You will work closely with your supervisor and be ready to take on any additional responsibilities as assigned. Your role is crucial in maintaining and enhancing the quality standards that define our organization.,

BMR Review, BPR Review, Line Clearance, Change Control, Deviation.

Scicore Nutra Private Limited is a state-of-the-art facility, located in Sanand Gujarat, is dedicated to producing high-quality nutrition products that are safe, effective, and meet the highest standards of quality. Our team of experts is committed to ensuring that every product we manufacture is produced with the utmost care and attention to detail. At our manufacturing unit, we use only the best raw materials and employ advanced manufacturing processes to ensure that our products are of the highest quality. We also adhere to strict quality control measures to ensure that every product meets our rigorous standards. This starts with doing a rigorous vendor qualification as well as testing of all raw materials supplied by these vendors for every batch. We do in-house stability studies to make sure our products last the full shelf life and give the best results to our customers. Our goal is to provide our customers with nutraceutical products that promote health and wellness, and we are committed to using science-backed ingredients and formulations to achieve this goal. We are also committed to continuous innovation and improvement and are always looking for new ways to enhance our products and processes. Company Benefits: 1. Free Air-Conditioned Transportation to the Factory 2. Paid Leave 3. Tea/Coffee & Canteen Facility 4. Accident Insurance 5. Provision for Bonus & Gratuity 6. Training programs for professional advancement Progressive work environment conducive to personal and professional growth. Role & responsibilities 1. Assist in performing in-process quality checks during the production of nutritional food products. 2. Conduct sampling and testing of raw materials, in-process products, and finished goods such as moisture content, pH levels, or texture. 3. Review and verify batch records, ensuring that they are complete, accurate, and compliant. 4. Assist in the preparation and documentation of IPQA-related reports and records. 5. Monitor cleanliness and hygiene standards in the production area. 6. Participate in internal audits and inspections as per company requirements. 7. Collaborate with production teams to resolve quality-related issues promptly. 8. Support the quality control team in investigating and resolving any quality-related issues or deviations. 9. Ensure adherence to Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMP), GDP, and other regulatory guidelines. 10. To follow the procedure for In process Checks in Production & Packing area 11. Review of all documents relating to the Manufacturing & Packing. 12. IPQA of Dispensing, Manufacturing, Packaging and Dispatch activities. 13. Preparation & Review of PROCESS VALIDATION and CLEANING VALIDATION protocols and records. 14. Preparation, Review and Issuing control of BMR & BPR. 15. To follow the Sampling procedure. 16. Provide LINE CLEARANCE in MIXING AREA, FILLING AREA, DISPENSING and PACKING AREA. 17. Knowledge of APQR Data Collection. 18. Calibration and Verification of Instrument (Leak Test & Weighing Balance) 19. Overall Responsibility to Review Logbooks, In-process formats and other online records.

Executive-CQA-VQG 1. To perform and track the Vendor Qualification Compliance and review for all vendors & AVDs. 2. To review, approve, and extend the Q info for new alternate vendors. 3.To execute vendor Audits, CAPA tracking, and qualification documentation 4.To schedule and monitor the Vendor Audits 5.To work on VQ special projects in coordination with Project IT team 6.To track the project till its implementation and Go Live across all sites Competencies 1. Strategic Agility 2. Innovation & Creativity 4. Developing Talent 3. Customer Centricity 5. Result Orientation Education Masters in Chemistry Post Graduation in Pharmacy 5-8 YearsWork Experience

About Us Morepen Proprietary Drug Research Pvt. Ltd. (MPDRPL) is a dynamic pharmaceutical R&D organization committed to developing high-quality, affordable generic and novel products for global markets. With a focus on innovation and regulatory compliance, we work in the area of ANDA, NCEs, 50b2, API development and novel polymorphs. Job Roles & Responsibilities Analytical Method Development & Validation: Develop and optimize analytical methods for pharmaceutical compounds using HPLC, GC, UV-Vis, and other analytical techniques. Perform method validation studies including accuracy, precision, linearity, specificity, and robustness testing. Transfer analytical methods between laboratories and ensure successful implementation. Troubleshoot analytical methods and resolve technical issues. Sample Analysis & Testing: Conduct routine analysis of raw materials, intermediates, and finished pharmaceutical products. Perform quantitative and qualitative analysis following established protocols and regulatory guidelines. Execute stability studies and analyze samples at designated time points. Instrumentation & Maintenance: Operate and maintain analytical instruments including HPLC, GC, GC-MS, FTIR, UV-Vis spectrophotometers. Perform routine calibration. Troubleshoot instrument issues and coordinate with service technicians when needed. Ensure proper documentation of instrument performance and maintenance activities. Data Management & Reporting: Analyze and interpret analytical data using statistical methods and software. Prepare technical reports, certificates of analysis, and regulatory submissions. Maintain accurate laboratory records and electronic data systems. Knowledge & Experience Master's degree in Analytical Chemistry, Chemistry, or related field. 2 - 4 years of relevant experience in pharmaceutical, chemical, or analytical laboratory settings. Strong foundation in analytical chemistry principles and techniques. Preferred Qualifications Experience with advanced analytical techniques (DSC, TGA). Previous experience in pharmaceutical or biotech industry. Understanding of stability testing and forced degradation studies. Knowledge of cleaning validation by UV / HPLC. Why Join MPDRPL? Be part of an organization driving cost-effective global healthcare solutions . Work on end-to-end projects from concept to market. Collaborate with experts across departments in a quality-driven, innovation-centric environment . Access to modern formulation laboratories and pilot-scale facilities. Competitive compensation with performance-linked incentives . Professional development and career advancement opportunities . Comprehensive employee benefits including healthcare and retirement plans .

JD Collaborate with cross-functional teams on equipment qualifications and IQS. Ensure IT compliance through validation processes. Develop computer system validation plans and protocols. QMS candidate shud b frm pharma industry gud communic skills. Cafeteria Office cab/shuttle Accessible workspace Health insurance Provident fund Annual bonus

As a Solution Tester, you will be responsible for: 1. Designing and automating test suites to ensure reliability of the system z(s390x) platform technology 2. Having a client-first mindset to test at scale and imitate customer-like environments 3. Creating strategies and scripts to test new features and functionalities 4. Contributing and reviewing code for internal and external repositories 5. Documenting processes (Test plans) and procedures for clarity and reproducibility 6. Interacting with counterparts in US/Germany teams and Red Hat Required education Bachelor's Degree Required technical and professional expertise Required Technical and Professional Expertise with relevant experience of 6-9 years: 1. Comfortable working with any of the three major Linux distros (Redhat, Sles, Ubuntu). Preferably on a Z system (s390x) 2. Knowledge on Web Services, API Testing 3. Understanding of virtualization and containerization concepts. z/VM and KVM are preferred. 4. Experience building pipelines for automation servers such as Jenkins etc 5. Skilled in a scripting language. Python, Ansible or bash is preferred. 6. Quick learner and a strong team player with good communication and interpersonal skills 7. Self Driven and Proven ability to work effectively in a global team environment. 8. Good decision making skills 9. skills on z/OS, CICS,Db2,IMS,MQ,DFSMS VSAM & VSAM ,RLS Preferred technical and professional experience 1. Leading and Guiding Team. 2.Providing direction and support to the team to achieve shared goals. 3. Taking initiative and anticipating needs or challenges before they arise

Responsibilities: * Conduct BPR reviews, change control procedures & equipment validation. * Ensure compliance with industry standards through quality assurance processes.

Job Overview To ensure effective quality assurance activities related to batch release, review of analytical data, batch records, QMS elements, and compliance with regulatory standards to support timely product release. Roles & Responsibilities: Batch Release Management Hands on analytical experience Review of QC Analytical Data including electronic data review Review of Batch Records including audit trail review Preparation and Review of APR Responsible for review of QC activities Initiation and review of QMS elements (Deviation/Change Control/OOS/OOT/CAPA) Dispatch and Line clearance Cleaning Validation Competencies Quick learner with excellent communication skills Punctual with proven track record of dedication & reliability A team player who is equally capable of working alone Fluent in both written and spoken English Knowledge /Experience in peptides Qualifications M.Sc. (Chemistry)/B. Pharm./ M.Pharm.

The ideal candidate should have strong knowledge of sportswear products and demonstrate His passion to achieve maintain the quality of products as per brand standards. Job Responsibilities Ensure raw materials and finished products meet specifications through meticulous examination and precise measurement tools. Perform durability, functionality, and safety tests to validate product quality and performance using standardized methods. Maintain detailed records of inspections, noting deviations or defects found to ensure traceability and quality control. Communicate identified defects promptly to supervisors and collaborate on corrective actions for timely resolution. Verify products meet industry standards, company policies, and regulatory requirements by staying updated on quality regulations. Oversee production stages to uphold consistent quality standards and identify areas for improvement in machinery and workflows. Develop and enforce effective protocols to optimize inspection processes and enhance product quality assurance Analyze quality-related customer concerns, identify root causes, and collaborate on solutions to prevent recurrence Ensure adherence to safety protocols during inspections and production activities to promote a secure workplace for all personnel. Requirements Candidate must have a graduation or any equivalent education. Having a bachelors degree can expand your job horizons and earning potential as well Real-time experience in the same domain is preferred Excellent documentation and presentation skills Excellent knowledge of Microsoft Excel, PowerPoint etc. Profound knowledge of quality control standards.

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.Approval signatory for all SOPs, Master Batch Records, Qualification, Validation, documents of Analytical and Manufacturing equipment, Specifications, Change Control, OOS investigations and other investigations, Stability Protocols, and other Master Documents. 8.Vendor Assessment. 9.Handling of OOS. 10Process validation and equipment cleaning validation. 11.To review batch production Records and Analytical documents, to assure that the batch has been manufactured and tested as per laid down procedure / specification. Deviation if any, are recorded, investigated, documented and authorized. 12.To export certification for batches intended for exports. 13.To release (approval or rejection) the batch manufactured at site. 14.To monitor qualification, validation and requalification activity at site. 15.To trend the data and analyses the trend. 16.To Prepare and approve Annual Product Quality Review for drug substance / drug product quality, Recommend the area of improvement, as applicable. 17. To investigate market compliant. Review response. 18.Handling of product recall. 19.To review Product License Application and support Regulatory department for obtaining the product license from the local Regulatory Authority. 20.To review and submit the data / information to Regulatory Affairs for preparation of DMF/dossiers/application for registration of the product with Regulatory Authority of the countries, intended to market the product. 21.To ensure implementation of the CAPA initiated as a result of self-audit, customer, regulatory audit.

Roles and Responsibilities Ensure compliance with quality management systems (QMS) through implementation, maintenance, and continuous improvement of ISO documentation. Prepare SOPs for various processes such as BMR, CAPA, Change Control, Cleaning Validation, etc. Conduct qualification testing and validation protocol execution to ensure product quality and regulatory requirements. Develop and maintain accurate records of test results, reports, and certificates related to quality assurance activities. Collaborate with cross-functional teams to identify areas for improvement in quality control processes. Desired Candidate Profile 5-10 years of experience in pharmaceutical industry with expertise in QMS implementation. Strong understanding of GMP regulations and industry standards like ISO 9001:2015. Proficiency in preparing documents like BMR, SOPs, Capas, Change Control procedures. Experience with cleaning validation process validation protocol execution.

Responsibilities: * Conduct BPR reviews, BMR reviews, process validation & cleaning validations. * Ensure compliance with industry standards during equipment & water validations. Accidental insurance Annual bonus Leave encashment Gratuity Provident fund

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

We are looking for a skilled QA Executive to join our team in the Agro Chemical Industry in Saykha, Bharuch, Gujarat. The ideal candidate will have 2-7 years of experience in quality assurance and control. Roles and Responsibility Develop and implement effective quality control processes to ensure high-quality products. Conduct regular audits to identify areas for improvement and implement corrective actions. Collaborate with cross-functional teams to resolve quality-related issues. Analyze data to identify trends and opportunities for quality improvement. Develop and maintain quality control documentation and records. Ensure compliance with industry regulations and standards. Job Requirements Bachelor's degree in any discipline. Proven experience in quality assurance and control. Strong analytical and problem-solving skills. Excellent communication and collaboration skills. Ability to work in a fast-paced environment and meet deadlines. Familiarity with industry-specific software and technologies.

QA Executive For Agro chemical Industry In Saykha,Bharuch, Gujarat Bharuch, Ahmedabad, Vadodara Job description Manage release of product batches, including owning the QA product release workflow in SAP. Lead and supervise a team of QA professionals to perform operations as described above. Review and approve Purchase Specifications and Analytical Standards Required Candidate profile Work to create an environment of open communication, participation &information-sharing within & between teams within QA &throughout facility

JOB DUTIES AND RESPONSIBILITIES (Please Mention In Below Table) 1 Manage release of product batches, including owning the QA product release workflow in SAP. 2 Lead and supervise a team of QA professionals to perform operations as described above. 3 Review and approve Deviation and Laboratory Investigations 4 Review and approve Purchase Specifications and Analytical Standards 5 Review and approve Issue Reviews and CAPA 6 Assist with Non-Conformance Investigations and provide guidance in identifying potential product impact and determination of final product disposition 7 Review and update Standard Operating Procedures (SOPs) for GMP compliance 8 Follow all regulatory guidelines, cGMP guidelines, Environmental Health and Safety regulations as required by the job function Review validation protocols and completed documents, including process qualification protocols for validations of commercial processes. 9 Work to create an environment of open communication, participation and information-sharing within and between teams within QA and throughout facility

Job Duties and Responsibilities (Please Mention In Below Table) 1 Manage release of product batches, including owning the QA product release workflow in SAP. 2 Lead and supervise a team of QA professionals to perform operations as described above. 3 Review and approve Deviation and Laboratory Investigations 4 Review and approve Purchase Specifications and Analytical Standards 5 Review and approve Issue Reviews and CAPA 6 Assist with Non-Conformance Investigations and provide guidance in identifying potential product impact and determination of final product disposition 7 Review and update Standard Operating Procedures (SOPs) for GMP compliance 8 Follow all regulatory guidelines, cGMP guidelines, Environmental Health and Safety regulations as required by the job function Review validation protocols and completed documents, including process qualification protocols for validations of commercial processe 9 Work to create an environment of open communication, participation and information-sharing within and between teams within QA and throughout facility 10 Work to create an environment of open communication, participation and information-sharing within and between teams within QA and throughout facility 11 Assist with complaint investigations for internally produced commercial product 12 Ensure compliance to all compendial, internal and client-specific requirements (SOPs, Quality Agreements, General and Informational Chapters in multiple compendia as applicable). 13 Ensure all work is performed and documented according to approved standard operating procedures, in general compliance with cGMPs and in a timely manner consistent with agreed upon schedules

The Senior Executive QA (Vendor Management) will be responsible for managing vendor qualification processes, preparing periodic vendor audit schedules, and ensuring vendor compliance in line with cGMP and global regulatory expectations. The role also involves reviewing and maintaining Quality Agreements, monitoring vendor performance, supporting cross-functional risk assessments, and ensuring timely closure of audit observations. The position demands strong coordination with cross-functional teams, external vendors, and regulatory bodies. Key Responsibilities: Execution and oversight of vendor qualifications Planning and coordination of vendor audits Preparation and review of Quality Agreements with external partners Risk assessments and periodic performance reviews of critical vendors Handling of audit observations and CAPA follow-up Supporting change control and deviation management related to vendors Qualifications B.Pharm / M.Pharm / M.Sc. in a relevant discipline 5-8 years of relevant experience in Quality Assurance, specifically in Vendor Management Sound knowledge of GMP regulations (USFDA, EU, MHRA, etc.) Experience in vendor audits and supplier qualification Strong documentation, communication, and interpersonal skills Proficiency in QMS tools and audit management systems

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 Preparation, Review and Execution of Process Validation Protocols and summary reports based on the Analytical results and Batch documents data.

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.