146 Cleaning Validation Jobs

As a responsible team member in the pharmaceutical manufacturing process, your role involves the following key responsibilities: - Conduct line clearance activities before starting various operations such as dispensing, manufacturing, filling, inspection, sealing, labeling, and packing. - Perform process validation, cleaning validation/verification, hold time study, media fill, and routine batch sampling according to protocol/SOP. - Review executed Batch Manufacturing Records (BMRs) and Batch Packaging Records (BPRs). - Perform in-process tests at different stages as per batch documents/SOP. - Review environmental monitoring and water trends. - Review different types of calibration certificates and planners. - Receive necessary resources for environmental monitoring from the microbiology lab and ensure proper handover of monitoring items back to the lab. - Monitor cGMP compliance on the shop floor. - Review various printouts such as CIP, SIP, autoclave, and filter integrity. - Maintain issuance/reconciliation records of items/media for environmental monitoring materials. - Conduct environmental monitoring of the manufacturing clean room area based on the defined schedule. - Participate in media fill simulation studies and qualification activities of the manufacturing area. - Monitor non-viable particles in the manufacturing clean room area and compressed air/nitrogen gas, as well as personnel monitoring. - Review Media Fill Completion Document (CD) and Visual Inspector Qualification Records. Additionally, you will need to manage environmental conditions like temperature, humidity, and light during stability testing to ensure accuracy and compliance. Qualifications required for this role include a Bachelor's (B.Sc.) or Master's (M.Sc.) degree. Please note that this job description pertains to a pharmaceutical manufacturing environment where attention to detail, adherence to protocols, and compliance with regulations are crucial for ensuring product quality and patient safety.,

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 A role-holder to handle/supervise the manufacturing activities and to ensure the on-time production and delivery of product with quality compliance and cost improvisation. Job Responsibilities Works in a safe manner collaborating as a team member to achieve all outcomes. Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion. Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies. All other relevant duties as assigned To be well disciplined & maintain the same in the production department. To maintain the safety and housekeeping practices at work place. To ensure and follow good and online documentation practices. To ensure proper labeling procedure wherever applicable as per procedure. To ensure that cleaning the area as per related SOP s are conducted and maintained as per proper cleanliness. To ensure the Calibration/Preventive maintenance of the equipment as per the schedule. To maintain and ensure cleaning and operation activities are performed as per procedure. To maintain the batch as per instruction given in batch document / procedure. To ensure material movement is conducted as per procedure. To ensure training of our self on current version of procedure prior to perform activity. To perform the activities assigned to him by the concerned section seniors or by his superiors in area. To follow the cGMP practices. To showcase the value of collobaration with own/other departments to complete the work assigned. To escalate immediately to concerned superior / manager for any deviation / non-compliance /abnormal observation. Shall always be ready to accept new challenges & multifunctional activities. Shall always stick to the time line provided or assignment given by superiors, to avoid any delays and any non-compliance. Works as a member of a team to achieve all outcomes. Performs all work in accordance with all established regulatory and compliance and safety requirements. To plan the production activities as per the weekly plan on daily basis & deliver the same to down level for its execution. To supervise the production process to produce quality formulation at optimum cost and within the time limit. To plan for various activities of the process and get it done within the specified time. Also maintain the online documentation related to production activities . To allocate the Job responsibilities for operators, housekeeping & contract labours in production area. To train the concern members on the related SOPs , newly updated SOPs , cGMP & documentation practices. To supervise the process validation & cleaning validation activities as per protocol in co-ordination with QA/QC. Create a culture which values trust and provides the opportunity for Employee development and growth in pursuit of our purpose and demonstrating our core Values Collaboration, Courage, Perseverance and Passion. All other duties as assigned. Job Requirements Education Pharmacy / M Pharmacy Knowledge, Skills and Abilities Adequate knowledge and ability in handling /supervising the manufacturing activities In depth knowledge of cGMP practices Identify and escalate equipment related issues. Experience 3 to 5 Years At Apotex, we are committed to fostering a welcoming andaccessible work environment, where all everyone feels valued, respected, and supported to succeed. We offer accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation. Show more Show less

Works independenly on creating test plans, executing tests, troubleshooting the issues, automating test cases, reporting bugs with all the required details, reviewing the tests, providing the test reports, analyzing test failures Capable of analyzing moderately complex challenges using analytical tools and data interpretation. Applies critical thinking to assess problems with relevant data independently to evaluate potential solutions after considering various possibilities. Engages in independent analysis and collaborates with others to gather insights and develop recommendations including challenging existing processes. Capable of working independently while actively contributing to team and organizational goals, with a growing ability to influence outcomes beyond department Incorporates and promotes new technology to improve data analysis, reporting and problem solving. Analyzes team processes to eliminate inefficiencies, leading to improved project timelines and resource allocation Contributes to department projects ; takes ownership of team projects, driving their execution and coordinating with others effectively. Recommends improvements at team level. Applies a large set of skills and knowledge effectively. Able to tailor consensual verbal and written communications that resonate with different stakeholders. Leverages network and engages independently with colleagues to achieve team goals. Shares best practices with others. Articulates and compares alternative approaches to tasks.Hiring manager and Recruiter should collaborate to create the relevant verbiage. Required education Bachelor's Degree Preferred education Bachelor's Degree Required technical and professional expertise 5+ years of experience in developing automation using Python. Hands-on developing PyTest fixtures. Good exposure to writing test plans, test cases and test reports compilation Good understanding of Github, Jenkins, Jira, Test management system Good understanding of Linux, Openshift Container Platform, Kubernetes, Openshift virtualization Good exposure to VMWare, Storage concepts like virtualization, backup and restore, Disaster recovery. Excellet problem solving and troubleshooting skills Good written and oral communication skills Preferred technical and professional experience Hiring manager and Recruiter should collaborate to create the relevant verbiage.Minimum 4 to 5 years of experience in developing automation using Python. Hands-on developing PyTest fixtures. Good exposure to writing test plans, test cases and test reports compilation Good understanding of Github, Jenkins, Jira, Test management system Good understanding of Linux, Openshift Container Platform, Kubernetes, Openshift virtualization Good exposure to VMWare, Storage concepts like virtualization, backup and restore, Disaster recovery. Excellet problem solving and troubleshooting skills Good written and oral communication skills

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 A role-holder to handle/supervise the manufacturing activities and to ensure the on-time production and delivery of product with quality compliance and cost improvisation. Job Responsibilities Works in a safe manner collaborating as a team member to achieve all outcomes. Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion. Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies. All other relevant duties as assigned To be well disciplined & maintain the same in the production department. To maintain the safety and housekeeping practices at work place. To ensure and follow good and online documentation practices. To ensure proper labeling procedure wherever applicable as per procedure. To ensure that cleaning the area as per related SOP s are conducted and maintained as per proper cleanliness. To ensure the Calibration/Preventive maintenance of the equipment as per the schedule. To maintain and ensure cleaning and operation activities are performed as per procedure. To maintain the batch as per instruction given in batch document / procedure. To ensure material movement is conducted as per procedure. To ensure training of our self on current version of procedure prior to perform activity. To perform the activities assigned to him by the concerned section seniors or by his superiors in area. To follow the cGMP practices. To showcase the value of collobaration with own/other departments to complete the work assigned. To escalate immediately to concerned superior / manager for any deviation / non-compliance /abnormal observation. Shall always be ready to accept new challenges & multifunctional activities. Shall always stick to the time line provided or assignment given by superiors, to avoid any delays and any non-compliance. Works as a member of a team to achieve all outcomes. Performs all work in accordance with all established regulatory and compliance and safety requirements. To plan the production activities as per the weekly plan on daily basis & deliver the same to down level for its execution. To supervise the production process to produce quality formulation at optimum cost and within the time limit. To plan for various activities of the process and get it done within the specified time. Also maintain the online documentation related to production activities . To allocate the Job responsibilities for operators, housekeeping & contract labours in production area. To train the concern members on the related SOPs , newly updated SOPs , cGMP & documentation practices. To supervise the process validation & cleaning validation activities as per protocol in co-ordination with QA/QC. Create a culture which values trust and provides the opportunity for Employee development and growth in pursuit of our purpose and demonstrating our core Values Collaboration, Courage, Perseverance and Passion. All other duties as assigned. Job Requirements Education Pharmacy / M Pharmacy Knowledge, Skills and Abilities Adequate knowledge and ability in handling /supervising the manufacturing activities In depth knowledge of cGMP practices Identify and escalate equipment related issues. Experience 3 to 5 Years At Apotex, we are committed to fostering a welcoming and accessible work environment, where all everyone feels valued, respected, and supported to succeed. We offer accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation. Show more Show less

Role & responsibilities Executive - QA Equipment Qualification Preferred candidate profile - Review of Equipment Qualification related documentation. - Review of Computer system validation related documentation. - Exposure of Software like EDMS, LMS, Trackwise. - Exposure of Cleaning validation.

Job Title: Sr. Executive Location: Bavla - Plant Department: QA Reporting To: Head of QA Employment Type: Full-Time Key Responsibilities: Prepare and review Cleaning Validation Protocols and Reports , including product matrix and MACO (Maximum Allowable Carry Over) calculations. Develop and execute protocols and reports for Clean Equipment Hold Time and Dirty Equipment Hold Time . Prepare, review, and finalize Process Validation Protocols and summary reports, utilizing analytical results and batch documentation data. Prepare and review Product Hold Time Protocols and Reports to ensure product quality throughout storage. Conduct thorough review of manufacturing documentation, including Master Formula Records (MFR), Manufacturing Process Records (MPR), Batch Manufacturing Records (BMR), and Batch Packaging Records (BPR) . Review and analyze the Annual Product Quality Review (APQR) to assess product performance and compliance. Prepare and review Standard Operating Procedures (SOPs) to ensure alignment with regulatory guidelines and internal standards. Review Stability Study Protocols and Reports to support product shelf-life determination. Oversee the preparation, review, and execution of Qualification and Validation activities for equipment, systems, and processes. Review and monitor the Training Plan to ensure effective implementation and documentation of employee training. Review and maintain Document Control Procedures to uphold quality and compliance standards. Maintain confidentiality of financial data and ensure accuracy and integrity in reporting.

Role Overview: As a Manager in the Quality Assurance department at ZLL-SEZ Oncology Injectable (Alidac), your role will be critical in handling in-process Quality Assurance functions. You will ensure that defined and approved IPQA checks are followed and documented during Dispensing, Manufacturing, filling, capping, and Packing stages. Your responsibilities will include ensuring compliance with Current Good Manufacturing Practices and sterility assurance activities in aseptic product manufacturing. Additionally, you will review Smoke study protocol, report, and Video recording, and participate in regulatory audits. Key Responsibilities: - Handle in-process Quality Assurance functions by ensuring compliance with defined IPQA checks during various stages of manufacturing - Ensure compliance with Current Good Manufacturing Practices and sterility assurance activities in aseptic product manufacturing - Review Smoke study protocol, report, and Video recording, and authorize final document approval in the absence of Head Quality Assurance - Participate in regulatory audits and ensure compliance - Review and approve Process validation, cleaning validation, aseptic process simulation protocol, reports, change control, deviation, incident reports, OOS, OOT, non-conformance, and CAPA in consultation with Head Quality Assurance Qualifications Required: - M. Pharm/B. Pharm qualification - 15 to 17 years of experience in the pharmaceutical industry - 03 years of experience at Zydus - Knowledge and experience in an injectable plant Please email your CV to isha.naik@zyduslife.com for consideration.,

Conduct quality inspections and tests on raw materials, in-process production, and finished products.Monitor and document quality control processes and compliance with quality standards.Identify defects or deviations

Conduct regular inspections and audits of products, processes, and systems.Identify quality issues and implement corrective actions.Develop and maintain quality documentation, including SOPs and checklists.

Conduct regular inspections and audits of products, processes, and systems.Identify quality issues and implement corrective actions.Develop and maintain quality documentation, including SOPs and checklists.

Key Responsibilities Lead, manage, and develop the QC function for pharma formulations as per company policies and regulatory requirements. Supervise and resolve lab incidents, deviations, change controls, OOS/OOT , and ensure robust documentation and root cause analysis. Oversee process validation, cleaning validation, hold time studies and related compliance activities. Establish and implement Stability Study protocols as per company SOPs, client specification, and all applicable quality standards. Handle product complaints & recall investigations in collaboration with QA and Production teams. Ensure compliance with current GMP, GLP, and regulatory guidelines for all laboratory operations. Maintain rigorous control of QC documentation, data integrity, and quality records. Coordinate external laboratory audits, regulatory inspections, and support internal audit programs. Train, mentor, and appraise QC staff for skills development and process improvements. Desired Candidate Profile Education: M.Sc / B.Sc / M.Pharm / B.Pharm (Chemistry/Pharmaceuticals/Relevant field) Experience: 15-20 years in Quality Control for pharma formulations (regulated plants preferred) Strong expertise in managing lab incidents, OOS/OOT, deviation, change control, validation activities, and stability protocols Well-versed with handling investigations for product complaints and recalls Familiar with global quality standards and client requirements Excellent leadership, team management, and communication skills Ability to collaborate cross-functionally and drive continuous improvement

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 regulations for catering industry Knowledge of MS Excel & Power Point Presentation

Summary Job Functions: Responsible for document review (Ex. Master MPCR/BPCR, QMS documents, SOP, Protocols & Reports) related to BBM, MSAT & R&D. Responsible for IPQA activities and Shop Floor Compliance in BBM Facility. Responsible for transactions required in software related to GMP activities Key Responsibilities: - Responsible for In-Process Quality Assurance activities (e.g. Area clearance, Issuance of MCB/ WCB/ EPCB Vial/ CI/ DS for batch processing, Verification of process steps as applicable and review of various processing parameters and its associated documentation related to BBM facility. - Review of new & revised documents and related transactions in respective software. (SOP, EBMR, BPCR, MPCR, TTD, PTN, Protocol, Report and QMS documents of BBM, MSAT and R&D). - Review of Change Controls, CAPA, Deviations, OOT, OOS and related transactions in respective software. - Preparation and Review of APQR related to CI and DS. - Responsible for Handling and review/assessment of FMS Alarm, Equipment Breakdown, SAP Incident and ERN (Error Ratification Notification) Handling. - Responsible for approval of material request from various user departments related to BBM facility. Responsible for approval/authorization of user access request related to BBM facility. - Review of Electronic record and Audit trail related to equipment/systems of BBM Facility. - Responsible for verification of BOM in SAP. Responsible for doing transactions related to BPCR review and Interim batch release in SAP. Responsible for QMS notification creation in respective software. - Responsible for EBMR/ E-Logbook Data creation, modification In SAP. Responsible for linking BOM with the effective MPCR in case of EBMR in SAP. - Monitoring and participation in Process Validation/Cleaning Validation activities of BBM. Review and compilation of Process Validation/Cleaning Validation documentation. - Participation in internal/external audits. - Preparation and review of the documents related to the quality assurance - Responsible for providing required document support to RA, R&D and DQA. - To follow Good Documentation Practices and Data Integrity’ requirements during any GxP Operation and recording at site.

As a QA (Quality Assurance) /Test Developer you will be designing better ways to identify potential weak spots, inefficiencies, and issues within software systems. This position will work closely with development teams and other test engineers in the implementation and delivery of software products that meet rigorous quality standards, budgets, and timelines. The role seeks good levels of personal organization, and the ability to work well with a distributed global team in a fast paced and exciting environment. You will play a key role by delivering quality functions for development teams within test driven framework. Your scope will include Test Plan Development, Test Case Execution, Automation Testing, Data Creation, API Validation and incorporating test automation in the CI/CD pipelines. Required education Bachelor's Degree Preferred education Master's Degree Required technical and professional expertise 2+ years of experience. Strong in Java Selenium and TestNG Java Proficiency Strong in Java OOPs concepts and experience in Automation testing using Java and JUnit framework. API Testing Hands on experience Excellent Problem-Solving Skills: Demonstrated experience in problem-solving, with the ability to tackle complex issues and find effective solutions. Collaborative DevelopmentWork closely with development teams to identify potential weak spots, inefficiencies, and issues within software systems, fostering a collaborative approach to software quality. Strong knowledge in manual Software Testing concepts. Preferred technical and professional experience Exposure to Linux based environment and Kubernetes Java Proficiency Strong in Java OOPs concepts and experience in Automation testing using Java and JUnit framework. API Testing Hands on experience Excellent Problem-Solving Skills: Demonstrated experience in problem-solving, with the ability to tackle complex issues and find effective solutions. Collaborative DevelopmentWork closely with development teams to identify potential weak spots, inefficiencies, and issues within software systems, fostering a collaborative approach to software quality. Strong knowledge in manual Software Testing concepts.

Core expertise in IPQA, 21 CFR compliance, validation & qualification, E-BMR/E-Log, QMS, risk assessment; skilled in audits, regulatory compliance, team management, training, and digital quality systems. Required Candidate profile B/MPharma 7 - 10 years of experience

Job Description 1. Preparation and review of operational packing materials list, Packaging materials specifications, Packaging materials specifications base documents, BOM, BPR (PAS X and SAP), In House Labels for Exhibit Batches, Pack Split Up and Pallet Matrix. 2. To provided technical support to Production, QA, QC and RA. 3. Review of Artwork, Shade cards and print proof etc. Initiate Change controls, Deviation and CAPA and close all action item of change control, CAPA and deviation within time frame preparation of investigation report of deviation. Coordinate with R&D and QA for Primary Packaging Materials Specifications, Primary Pack Specification and Standard Test Procedures. 4. Preparation and Review of SOP’s, Protocols and Reports. Supervise compliance to all cGMP or any other regulatory requirements, including EH&S requirements. Execute and supervise all tasks and activities as per applicable SOP’s. Work Experience 2-4 years Education Graduation in Pharmacy Diploma in Packaging Technology Competencies Innovation & Creativity Result Orientation Collaboration Customer Centricity Developing Talent Stakeholder Management Strategic Agility Process Excellence

Job Description Join Lupin Limited in the role of Junior Officer within our Quality division, specializing in Validation activities. This position is integral to ensuring the highest standards in cleaning validation processes for Active Pharmaceutical Ingredient (API) facilities. Your primary responsibility will involve managing and executing comprehensive cleaning validation protocols to guarantee product safety and regulatory compliance. Key responsibilities include: Conducting residue cleaning validation to verify the removal of contaminants from manufacturing equipment. Performing nitrosamine cleaning validation to monitor and control genotoxic impurities in line with current global regulatory expectations. Carrying out genotoxic cleaning validation studies to assess and mitigate the risk of harmful agents. Calculating Risk Priority Numbers (RPN) as part of Failure Mode and Effects Analysis (FMEA) to evaluate and prioritize risks in cleaning processes. Executing Campaign Effectiveness and Hold Time (CEHT) and Degradation Effectiveness and Hold Time (DEHT) studies to ensure product integrity and process reliability. Being responsible for the qualification and validation of facilities, equipment, utilities, areas, and HVAC systems to ensure adherence to Good Manufacturing Practices (GMP) and internal quality standards. Preparing detailed and accurate validation documentation, including protocols, reports, and compliance records to satisfy auditing and regulatory requirements. In addition to technical expertise, the role demands a proactive approach to continuous improvement initiatives and collaboration across cross-functional teams to enhance process efficiency and safety. Lupin Limited fosters an inclusive work culture that values innovation, quality, and the development of talent. This role provides an excellent opportunity to contribute to pharmaceutical quality assurance, while growing your career within a leading global organization. Work Experience Applicants should have 2 to 5 years of relevant experience in pharmaceutical cleaning validation or related quality assurance roles within a regulated environment. Experience in handling validation of facilities, equipment, and utilities in API manufacturing settings is highly desirable. Strong knowledge of cleaning validation principles, risk assessments, and regulatory expectations is essential. Education Graduation in Pharmacy Competencies Strategic Agility Innovation & Creativity Customer Centricity Developing Talent Result Orientation Process Excellence Collaboration Stakeholder Management

Job Description Join Lupin Limited's dynamic Quality division as an Officer within our Validation department based in Pithampur. In this pivotal role, you will take charge of the cleaning validation activities for our API and Formulation facilities. Your responsibilities will encompass comprehensive management and execution of validation protocols supporting our commitment to the highest quality manufacturing standards. Your core duties will include ensuring rigorous residue cleaning validation processes to maintain contamination-free production environments. You will manage and evaluate nitrosamine and genotoxic cleaning validation activities, essential to safeguarding product safety and regulatory compliance. In addition, you will perform risk priority number (RPN) calculations to identify and mitigate potential risks effectively. Campaign studies including CEHT/DEHT will fall within your scope, enabling process optimization and validation integrity. The role extends to qualification activities for facilities, equipment, utilities, and HVAC systems, ensuring all operate at validated standards aligned with industry and regulatory requirements. As the Officer, you will prepare and review validation-related documentation with precision, supporting audit readiness and continuous improvement initiatives. Your efforts will directly contribute to Lupin's mission of delivering safe, efficacious pharmaceutical products to global markets. We seek an individual with a keen eye for detail, exceptional organizational skills, and the ability to collaborate cross-functionally. Your proactive approach to validation and quality processes will drive success and uphold our high standards. At Lupin Limited, you will be part of a culture that values innovation, strategic thinking, and continuous development. Join us to advance your career in a challenging and rewarding environment where your expertise makes a meaningful difference. Work Experience Applicants should have between 2 to 5 years of relevant experience in pharmaceutical cleaning validation or quality assurance sectors. Experience in executing and managing cleaning validation protocols, facility and equipment qualification, as well as working knowledge of regulatory requirements related to pharmaceutical manufacturing, will be highly valued. Education Graduation in Pharmacy Competencies Strategic Agility Innovation & Creativity Customer Centricity Developing Talent Result Orientation Process Excellence Collaboration Stakeholder Management

1. Monitor raw material dispensing activity. 2. Perform daily IPQA activities as per SOP-defined frequency and ensure timely closure of IPQA observations. 3. Conduct validation sampling as per approved validation protocols. 4. Review BMR (Batch Manufacturing Record) and BPR (Batch Packing Record) for accuracy and compliance. 5. Perform ERP-related transactions of IPQA. 6. Check BSR (Batch Summary Record) and Shipper inspection as per SOP. 7. Manage issuance, review, and reconciliation of formats across all departments. 8. Conduct IPQA rounds and share observations with concerned HODs for corrective action and compliance. 9. Ensure cleaning, sanitation, and hygiene in all departments to maintain GMP compliance at all times. 10. Perform sampling of In-process, Semi-Finished Goods (SFG), and Finished Goods (FG) as per procedure. B.Pharm / M.Pharm / M.Sc. in relevant discipline. 2-5 years of experience in IPQA or Quality Assurance within the pharmaceutical industry.

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

QA Manager OSD/Liquid formulation background.Must have experience in BMR, batch release,validations,qualifications,SOPs,GMP,audits,QMS(Deviation,OOS, OOT, CAPA), tech transfer. Analytical exposure is an added advantage Resume to hrd@stedmanpharma.com

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

As a Senior QA Officer, your role will involve various responsibilities to ensure quality assurance within the API pharma industry. You will be tasked with issuing Batch Manufacturing Records, equipment cleaning records, logbooks, and analytical reports for raw materials, finished products, and packing materials. Additionally, you will assist in the preparation of SOPs for different departments and conduct plant rounds to verify documents according to cGMP and GLP norms. Line clearance activities for manufacturing and packaging, issuing deviation forms, change control forms, and handling customer complaints will also be part of your duties. You will review and verify analytical and Batch Manufacturing Records, participate in audits and inspections, and ensure data integrity as per procedures. Maintaining documents and records, controlling SOPs and departmental documents, and preparing for internal and customer audits are crucial aspects of the role. You will also oversee activities related to manufacturing, store, and QC, as well as prepare vendor lists, conduct traceability activities, and manage CAPA logs. Ensuring compliance with equipment maintenance, calibration, and training on cGMP and GLP will be essential. Investigating deviations, product complaints, and environmental incidents, as well as conducting process validation and equipment qualification, will also fall under your responsibilities. Your role will involve preparing annual product reviews, handling waste disposal procedures, and supporting environmental management initiatives within the department. Additionally, any other assignments or tasks allocated by the Head of QA will be expected from you. If you are interested in this position or have a suitable reference, please contact Jyoti at 8657017223. This is a full-time job with day shift hours, based in Ankleshwar.,

We are seeking a dedicated Senior Validation position at a reputed pharmaceutical organization based in Ahmedabad. Experience : 5+ Years Qualification : B.Pharma Role & responsibilities Thermal mapping for mixing/holding vessels, steam sterilizers (autoclaves), terminal sterilizers, depyrogenation tunnels, lyophilizers, filling machines, cold rooms, and cleanroom areas, Media fill Isolator and HVAC system ,Process validation and equipment Utility : compressed air, nitrogen, and steam quality testing. Change control, CAPA, and process understanding. Protocol, validation report, and SOP preparation , Cleaning validation. Interested candidate with the required qualification and experience are encouraged to send their CV to recp@factjobs.com .

Job Title: Assistant Manager In-Process Quality Assurance (IPQA) Department: Quality Assurance Location: Hyderabad, Jeedimetla Reporting To: Manager Quality Assurance / Head Quality Job Purpose: To ensure that all in-process operations are monitored and compliant with applicable cGMP, SOPs, and regulatory requirements. The IPQA Assistant Manager is responsible for in-line quality checks, deviation control, batch record review, and timely escalation of non-conformities during manufacturing and packaging processes. 1. In-Process Quality Monitoring Supervise and execute IPQA activities during manufacturing and packaging. Perform real-time line clearance, process checks, and verification. Ensure compliance with Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR). 2. Documentation and Compliance Review in-process documents for accuracy and completeness. Ensure that manufacturing and packaging operations are performed as per SOPs and GMP guidelines. Maintain and archive IPQA records in a compliant manner. 3. Deviation & Change Control Identify, report, and investigate deviations, non-conformities, and incidents. Assist in the implementation of CAPA (Corrective and Preventive Actions). Coordinate with production, quality control, and other departments to resolve quality issues. 4. Audits & Regulatory Compliance Assist during internal, external, and regulatory audits (e.g., USFDA, MHRA, WHO). Ensure readiness of IPQA documentation and process compliance. Implement audit recommendations in coordination with QA leadership. 5. Training & Team Management Train IPQA staff and production teams on quality systems, SOPs, and GMP. Supervise IPQA officers/inspectors and ensure their optimal performance. Promote a culture of quality and continuous improvement on the shop floor. Key Skills and Competencies: Strong knowledge of cGMP, GDP, and regulatory standards (USFDA, MHRA, WHO-GMP, etc.) Excellent documentation and communication skills. Experience with QMS tools (e.g., deviation, change control, CAPA systems). Ability to lead and coordinate cross-functional teams. Qualifications: B.Pharm / M.Pharm / B.Sc / M.Sc in Chemistry, Microbiology, or related discipline. Experience: Minimum 6-10 years of relevant experience in IPQA, preferably in pharmaceutical manufacturing (API).