138 Equipment Qualification Jobs

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

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.

This role is responsible for technology transfer, process scale-up, equipment selection, and process validation in API manufacturing. The position ensures that the selected equipment aligns with process requirements, product quality, safety, and regulatory compliance, while supporting continuous improvement and operational excellence. Key Responsibilities: 1. Technology Transfer & Scale-up Lead the transfer of chemical processes from R&D to manufacturing. Evaluate and optimize process parameters for scale-up using mass and energy balances. Collaborate with Engineering for facility fitment, equipment readiness, and plant execution. 2. Equipment Selection & Sizing Analyse process requirements (reaction type, pressure/temperature profile, mixing, solvent use, etc.) to recommend suitable equipment. Select and size reactors, centrifuges, dryers, heat exchangers, condensers, and other equipment based on: Reaction kinetics and thermodynamics Process safety and control requirements Material compatibility and GMP compliance Evaluate batch vs. continuous processing options. Ensure scalability, containment, cleanability, and GMP compliance. Review P&IDs and layouts with Engineering and Production teams. 3. Process Optimization & Validation Conduct trials for equipment qualification and process optimization. Prepare and execute process validation protocols and reports. Lead QbD, DoE, and Process Analytical Technology (PAT) initiatives. 4. Documentation & Compliance Prepare/review equipment specifications, MFRs, BMRs, risk assessments, and validation documents. Ensure adherence to ICH Q8Q11, cGMP, USFDA, EUGMP, and other global guidelines. Support data generation for DMF filings and regulatory responses. 5. Cross-functional Collaboration Coordinate with R&D, QA, QC, Production, Engineering, EHS, and Regulatory Affairs. Provide technical training to operations and quality teams. Participate in internal/external audits and ensure compliance. 6. Continuous Improvement & Troubleshooting Analyse deviations and implement process/equipment modifications. Identify bottlenecks and recommend process/equipment upgrades. Drive cost-saving and productivity initiatives through efficient process/equipment utilization. Required Qualifications & Skills Education: B.E./B.Tech/M.Tech in Chemical Engineering or M.Sc. in Chemistry. Experience: 7 - 10 years in Technical Services, Process Engineering, or API Manufacturing. Strong understanding of process engineering and equipment design principles. Proven hands-on experience in selecting equipment for reactions, crystallization, drying, and filtration. Proficiency in PFDs, P&IDs, and risk mitigation strategies for scale-up. Working knowledge of process simulation tools (Aspen, ChemCAD, etc.) preferred. Familiarity with cGMP, regulatory requirements, and process safety norms.

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

Perform routine and non-routine quality control tests using analytical techniques such as HPLC, GC, UV-Vis, IR, titration, and others.Develop, validate, and optimize analytical methods as per regulatory guidelines.

Job Title: Test Engineer - Equipment Qualification Job Description Lead and execute qualification test programs. Perform and execute testing in compliance with quality assurance and safety requirements. Prepare test reports using data and results obtained during testing. Work with project managers and subsystem/component leads to develop and maintain project schedules. Lead complex technical projects, coordinating multi-functional teams to accomplish project objectives while meeting established schedule and budget requirements. Support preparation of requests for quotation (RFQs) and project change offers including scope statements, specifications, costs estimate, plans and schedules. Identify and define technical issues, risks, and challenges direct efforts to successful resolution. Comply with industry, regulatory, or agency codes and standards pertinent to equipment qualification. Collaborate with design engineers to identify design features which require qualification. Provide technical guidance, direction, and collaborate with other personnel including partners such as outside labs, sub-contractors, suppliers, fabricators, and customers. Provides consult to establish qualification strategy for product obsolescence. Collaborate with project managers to address risks, estimate cost and schedule. Train and coach other engineers Maintain nuclear safety and a safe working environment. Develop and maintain effective business relationships with Westinghouse customers. Strongly Preferred EMC Seismic Qualifications Harsh Environment Qualification Mild Environment Qualification Strongly Preferred Testing Knowledge Equipment, Components, and Systems used in Nuclear Power Plants Control Cards Modems to Breakers, Switches Cables Instrumentation & Control Cabinets Prior experience working in lab/testing environment (academic or industry lab) Mechanical and/or electrical problem-solving skills Strong organizational, planning skills, and attention to detail Highly motivated, self-starter Good judgment and the ability to prioritize a number of diverse tasks Orientation toward achieving Customer Success Effective communication, teaming and team building skills Strong technical writing ability Ability to multitask and work on multiple projects at a time Preferred working knowledge of IEEE and Reg Guide standards for Equipment Qualification Preferred experience in the nuclear industry, specifically in nuclear power plant safety/non-safety systems with working knowledge of 10CFR50 Appendix B, NQA-1, and 10 CFR Part 21 Familiar with the below regulations and standards : IEEE 323 IEEE 344 IEEE C37.82 IEEE C37.98 IEEE C37.81 Regulatory Guide 1.180 MIL-STD-461 IEC 61000-4 EPRI 102323 Mandatory Skills Thermal Testing,EMC Test,Equipment Qualification,Temperature Testing

As the Plant Manager for the Drug Product Plant at Piramal Critical Care (PCC), your role involves overseeing the overall operations and activities of the plant. You will be responsible for production and manpower planning, ensuring that products are manufactured and stored according to approved procedures to maintain quality standards. Your key responsibilities include: - Overseeing production and manpower planning - Ensuring execution of Batch Production Records as per cGMP requirements - Qualification of equipment and instruments - Conducting product validations in line with regulatory requirements - Monitoring and maintaining stock of consumables, logbooks, and status labels - Coordinating with service departments for production-related activities - Leading investigations of market complaints and quality incidents - Implementing CAPA against root causes of deviations - Participating in management reviews for process performance and quality improvements - Ensuring compliance with legal, statutory, ISO, and OHSAS requirements - Identifying and evaluating risks, hazards, and environmental aspects Qualifications required for this role include: - Qualification: B.Pharm / M.Pharm / M.Sc / B.Tech (Chemical) or equivalent - Experience: 15-20 years in Drug Product manufacturing with exposure to regulatory environments - Strong leadership, communication, and people management skills - Proficiency in SAP and other manufacturing-related systems About PCC: Piramal Critical Care (PCC), a subsidiary of Piramal Pharma Limited, is a global player in hospital generics and the third largest producer of Inhaled Anaesthetics. PCC is committed to delivering critical care solutions globally and maintaining sustainable growth for stakeholders. With a presence in the USA, Europe, and over 100 countries, PCC's product portfolio includes Inhalation Anaesthetics and Intrathecal Baclofen therapy. PCC has state-of-the-art manufacturing facilities in the US and India, cleared by regulatory bodies like the US FDA and UK MHRA. The team at PCC comprises a highly qualified global workforce focused on expanding the company's global footprint. Equal Employment Opportunity: Piramal Group ensures equal employment opportunities for all applicants and employees based on merit, qualifications, skills, and achievements. The company values ethical and inclusive growth practices. Please note that as the Plant Manager at PCC, you will need to possess hands-on experience in serialization, equipment qualification, regulatory audits, process investigations, and customer complaint handling. Knowledge of Lean and Six Sigma methodologies will be beneficial for this role.,

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

As the individual responsible for the overall operations and activities of the Drug Product Plant, you will play a crucial role in ensuring the production and manpower planning for the plant. Your primary focus will be to oversee that products are manufactured and stored in compliance with approved procedures and documentation to maintain the highest quality standards. It will be your responsibility to review and ensure the execution of Batch Production Records in accordance with cGMP requirements. You will also be in charge of ensuring the qualification of equipment and instruments is carried out as scheduled and that product validations are conducted as per regulatory requirements. Monitoring and maintaining the minimum stock of consumables, logbooks, and status labels will be part of your daily tasks. You will need to coordinate with various service departments for production-related activities and attend GMP and safety trainings, implementing the outcomes in the workplace. Leading investigations of market complaints and quality incidents will be under your purview, including implementing effective CAPA against root causes. You will participate in management reviews on process performance and quality, aiming to drive continual improvements. Ensuring timely communication and escalation of quality issues to appropriate management levels will be vital to maintaining operational efficiency. Your role will also involve overseeing production activities in line with predefined procedures and guidelines, ensuring audit readiness, compliance with stipulated timelines, and adherence to legal, statutory, ISO, and OHSAS requirements. Identifying and evaluating risks, hazards, and environmental aspects, as well as developing and monitoring objectives and targets under ISO and OHSAS standards, will be essential responsibilities. In the absence or authorization of senior management, you will act as the department lead and must possess knowledge and hands-on experience in serialization, equipment qualification, regulatory audits, process investigations, deviations, customer complaints, as well as Lean and Six Sigma methodologies. **Qualifications:** - Qualification: B.Pharm / M.Pharm / M.Sc / B.Tech (Chemical) or equivalent - Experience: 15-20 years in Drug Product manufacturing/Formulation with exposure to regulatory environments - Strong leadership, communication, and people management skills - Proficiency in SAP and other manufacturing-related systems This role offers you the opportunity to be a key player in the Piramal Critical Care team, contributing to the vision of delivering critical care solutions globally and enabling sustainable growth for all stakeholders. You will be part of a dynamic environment that values inclusive growth, ethical practices, and equal employment opportunities based on merit. Piramal Critical Care (PCC) operates under Piramal Pharma Limited (PPL), a subsidiary of Piramal Enterprises Limited, and is a significant global player in hospital generics, particularly in the production of Inhaled Anaesthetics. With a wide presence across the USA, Europe, and over 100 countries, PCC's product portfolio includes Inhalation Anaesthetics and therapies for spasticity management. As part of the PCC team, you will join a highly qualified workforce committed to expanding the global footprint in the critical care space. Together with Piramal Group, PCC actively engages in corporate social responsibility initiatives, collaborating with partner organizations to provide hope and resources to those in need and caring for the environment.,

The Manager Production Planning and Operational Excellence at Jhagadia and Dahej units is a key role responsible for overseeing the day-to-day plant operations to achieve annual production targets and operational objectives at the manufacturing facilities. This position requires providing leadership, guidance, and direction to enhance production, planning, time cycle efficiency, yield improvement, new plant commissioning, and quality management systems. Key Responsibilities: - Collaborate with VP Operations for technical support and new plant commissioning. - Develop monthly production plans based on BD team requirements. - Implement and monitor Overall Equipment Effectiveness (OEE) to optimize production capacity. - Drive operational excellence initiatives to enhance yield, productivity, and reduce resource consumption. - Track utility consumptions and work towards reducing them. - Maintain production, yield, and consumption data for analysis and improvement. - Conduct training for shop floor teams on operational excellence and quality management systems. - Support in commissioning new plants and equipment qualification. - Work on energy and cost-saving projects under the guidance of VP Operations. - Ensure on-time customer delivery and address complaints promptly. Job Specification: - 10-15+ years of manufacturing experience with expertise in new plant commissioning and operational excellence. - Proficiency in plant P&L management, process optimization, and operational skills. - Ability to work in an unstructured environment and set up processes effectively. - Strong leadership, teamwork, and passion for developing shop floor teams. Desired Qualities in a Candidate: 1. Strong technical and operational skills to drive productivity and quality. 2. In-depth knowledge of manufacturing processes, QMS, and cost-saving strategies. 3. Excellent communication and interpersonal skills, proficiency in English, Hindi, and Gujarati. 4. Executive presence to ensure result orientation, customer focus, and operational excellence. Other Requirements: - Bachelor's or master's degree in chemical engineering. - Hands-on experience in new plant commissioning and QMS implementation. - Strong integrity, result orientation, and leadership qualities. - Reporting to VP Operations, the role involves interactions with senior management during interviews. About Sigachi: Sigachi Industries Limited is a leading healthcare company specializing in Pharmaceutical, Food & Nutrition industries. With a focus on quality and innovation, Sigachi operates multiple facilities across India and is certified by various regulatory bodies. The company fosters employee creativity, expertise, and wellbeing to achieve its vision of creating a happy and healthy world. Sigachi is committed to diversity, equity, and inclusion in its hiring and people management practices to drive overall business growth.,

Preparation of documents such as IQ, OQ, DQ Job Description- (Incumbent needs to do/ Needs to know/ Outcome anticipated) Preparation of Project documents such as IQ, OQ, DQ as per requirement Incumbent needs to know - Basics of documents such as IQ, OQ, DQ - Excel, Word Experience Handling documentation activities for Minimum 6 months, preferably for WT projects in pharma.

Job Overview As an R&D/Product Development Engineer, you will be responsible for implementing and growing the capabilities and services of balloons provided by the Components group, primarily with Balloons (extrusion and forming). This will be a fast-paced role where we design new products for new and existing markets, qualify tooling, and specify new capital equipment investments. You will also work alongside with Operations and parallel R&D teams to understand design criteria to optimize quality and maximize throughout. Responsibilities & Required Skills Responsibilities: Implement and grow new technology of Balloons (extrusion and forming) Procure & qualify capital equipment, tooling, and fixtures for development and manufacturing Subject matter expert in the material properties of thermoplastic polymers and balloon forming processes to ensure optimized design inputs and outputs Support development of equipment, process, and measurement strategy as related to Balloons Plans, organizes, and manages related projects and staff as appropriate Train, mentor, and provide direction to Operators and Technicians. Support sustainable operations as a subject matter expert Design and integrate related test methods Understand customers applications and design products to meet application demands Lead the development of balloon forming equipment, process, and measurement strategy Directly review and validate the measurement results of development balloon runs Collaborate across operations and engineering teams to build consensus, summarize data to drive progress, to draws conclusions, and to create recommendations Qualifications Bachelor s Degree in Chemical, Mechanical, Material Science, or other related fields. A minimum of 5 years of industry experience in a manufacturing environment Extrusion/Injection molding/related experience preferred Innovative idea-generator who enjoys leading teams and mentoring others Problem-solving mindset backed up by solid statistical analysis skills Self-starter, self-motivator with the ability to work effectively in a team environment 1+ years of experience of indirectly providing direction to support technicians is preferred IQ/OQ/PQ experience a plus Six Sigma, lean certification a plus SAP experience a plus Competencies Location

Job Overview As an R&D/Product Development Engineer, you will be responsible for implementing and growing the capabilities and services of balloons provided by the Components group, primarily with Balloons (extrusion and forming). This will be a fast-paced role where we design new products for new and existing markets, qualify tooling, and specify new capital equipment investments. You will also work alongside with Operations and parallel R&D teams to understand design criteria to optimize quality and maximize throughout. Responsibilities & Required Skills Responsibilities: Implement and grow new technology of Balloons (extrusion and forming) Procure & qualify capital equipment, tooling, and fixtures for development and manufacturing Subject matter expert in the material properties of thermoplastic polymers and balloon forming processes to ensure optimized design inputs and outputs Support development of equipment, process, and measurement strategy as related to Balloons Plans, organizes, and manages related projects and staff as appropriate Train, mentor, and provide direction to Operators and Technicians. Support sustainable operations as a subject matter expert Design and integrate related test methods Understand customers applications and design products to meet application demands Lead the development of balloon forming equipment, process, and measurement strategy Directly review and validate the measurement results of development balloon runs Collaborate across operations and engineering teams to build consensus, summarize data to drive progress, to draws conclusions, and to create recommendations Qualifications Bachelor s Degree in Chemical, Mechanical, Material Science, or other related fields. A minimum of 5 years of industry experience in a manufacturing environment Extrusion/Injection molding/related experience preferred Innovative idea-generator who enjoys leading teams and mentoring others Problem-solving mindset backed up by solid statistical analysis skills Self-starter, self-motivator with the ability to work effectively in a team environment 1+ years of experience of indirectly providing direction to support technicians is preferred IQ/OQ/PQ experience a plus Six Sigma, lean certification a plus SAP experience a plus Competencies Location

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

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.,

Job Title: Manager Quality Assurance (QA) Company: Global Calcium Pvt. Ltd. Location: Unit III – Hosur, Tamil Nadu Experience: 10+ years Qualification: B.Pharm / M.Pharm / M.Sc or equivalent Job Description: We are looking for an experienced Manager – QA to lead our Quality Assurance team at Global Calcium Pvt. Ltd., Unit III (Hosur). Key Responsibilities: Lead Quality Management System (QMS) activities in compliance with cGMP and regulatory requirements. Manage validation and qualification of equipment, utilities, and processes. Ensure audit readiness and compliance with regulatory agencies (USFDA, EU, WHO, MHRA). Review and approve SOPs, protocols, and reports related to validation and qualification. Handle internal audits, external inspections, and CAPA implementation. Guide, mentor, and develop the QA team to strengthen the quality culture. Desired Candidate Profile: 10+ years of experience in QA in the pharmaceutical industry. Strong knowledge of QMS, Validation & Qualification. Excellent communication and leadership skills. Exposure to international regulatory guidelines preferred. Salary: Best in the industry (not a constraint for the right candidate). Industry Type: Pharmaceuticals / API / Bulk Drugs Functional Area: Quality Assurance Employment Type: Full Time, Permanent How to Apply: Interested candidates may share their CV to suganya@globalcalciumpharma.in with the subject line “Application for Manager – QA” .

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 IPQA rounds and ensure adherence to in-process checks. 3. Regulatory Compliance & Audits: Coordinate and face internal, customer, and regulatory audits. Prepare CAPA reports and ensure timely closure of audit findings. Provide quality-related data for regulatory filings including DMFs. 4. Training & People Development: Conduct GMP and QA-related trainings as per monthly/yearly plans. Evaluate personnel qualification reports and assign qualification numbers. Promote a culture of continuous improvement and compliance across teams. 5. Material Management & Specification Review: Qualify vendors through supplier audits and documentation. Review and approve specifications for finished products, APIs, raw materials, packaging materials, and TDS. Monitor stability studies and review summary reports for product shelf life and storage conditions. 6. Logbooks, Formats & Communication: Prepare and issue formats, logbooks, and registers. Handle email communications for quality-related queries and documentation. Participate in cross-functional assignments and responsibilities delegated by HOD.

Assistant Manager / Sr. Executive based in Kadi, Mehsana District, Gujarat. The ideal candidate brings 5 to 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). Additional info: Key Skills: GMP Documentation, Batch Execution, Troubleshooting, R&D Tech Transfer, Process Optimization Experience: 5 to 10 years Must demonstrate strong ownership, attention to detail, and the ability to work in a fast-paced, inspection-ready environment. Familiarity with ICH, WHO TRS, ISPE, and data integrity principles is expected; hands-on with spreadsheets/ERP/LIMS is a plus.

We are looking for contractual resource for CSV on very High priority for our team. Can you please ask vendors to share start sharing the profiles with 3-7 Years of experience range. Author, Review, and Approve CSV deliverables Validation Project Plan with different Stakeholders Follow Computer Systems Validation, CSV, and Processes to the author, review and approve CSV deliverables for systems. Take ownership of the CSV and Equipment Qualification effort on different Hardware and Software Tools and fixtures being used across different Teams Co-ordinate with the different teams for understanding their requirements and validate the system accordingly Review and identify validation deviations and resolve deviations with appropriate corrective/preventive actions Directly work with QA/Design/Test teams for implementing new and upgrading previously validated systems Organize and attend the meeting to discuss the status of the projects. Create and provide computer validation training programs to ensure Regulatory Compliance Assess risks related to the systems and analyze them, if necessary with the Team Review and follow SOPs to help the business process in line with FDA regulations. Follow the risk analysis process, assessment process, and change control procedures for different systems as per Stryker rules and regulations Tools Knowledge : Val-genesis Computer System Validation, Csv

Job Description : Responsible for the overall operations and activities of the Drug Product Plant. Oversee production and manpower planning for the Drug Product Plant. Ensure products are manufactured and stored as per approved procedures and documentation to maintain quality standards. Review and ensure execution of Batch Production Records (BFR, BPR, etc.) as per cGMP requirements. Ensure qualification of equipment and instruments is carried out as per schedule. Ensure product validations are conducted in line with regulatory requirements. Monitor and maintain minimum stock of consumables, logbooks, and status labels. Ensure preventive maintenance of equipment as per the defined schedule. Coordinate with service departments (QA, QC, Stores, SCM, EHS, E&M) for production-related activities. Attend GMP and safety trainings and implement training outcomes at the workplace. Ensure initial and continual training of department personnel is conducted and updated as per need. Oversee production-related inputs in SAP and ensure timely FG transfers. Lead investigations of market complaints and quality incidents. Investigate market complaints, deviations, and quality incidents, and implement effective CAPA against root causes. Participate in management reviews on process performance, quality, and drive continual improvements. Ensure timely and effective communication and escalation of quality issues to the appropriate management levels. Ensure production activities are executed as per predefined procedures and cGMP guidelines. Ensure audit readiness and compliance with stipulated timelines. Ensure compliance with legal, statutory, ISO, and OHSAS requirements. Identify and evaluate risks, hazards, and environmental aspects and review them periodically. Develop and monitor objectives and targets under ISO and OHSAS standards. Identify SHE training needs and ensure awareness and competence among department personnel. Act as department lead in the absence or authorization of senior management. Possess knowledge and hands-on experience in serialization. Possess knowledge and hands-on experience in equipment qualification. Demonstrated experience in independently handling regulatory audits. Hands-on experience in process investigations, deviations, and handling customer complaints. Knowledge and practical experience in Lean and Six Sigma methodologies.

Job Title: CQV Engineer Location: Bangalore Experience: 3-4 years in pharma CQV 1. Commissioning Activities: Authoring of commissioning protocols (e.g., Installation Checks, Functional Testing) for equipment and Utilities such as Reactors, centrifuges, dryers, HPLC etc. Participate and coordination with engineering & OEMS for FAT/SAT. Authoring of DQ, System Impact Assessment and Risk Assessment documents in coordination with OEM. 2. Qualification and Validation: Author, review, and execute qualification protocols: Installation Qualification, Operational Qualification, and Performance Qualification for process equipment. Perform Qualification as per the regulatory requirements (e.g., FDA, WHO). 3. Documentation: Should have sound knowledge in good documentation Practices and QMS process throughout the CQV lifecycle. Coordination with engineering, manufacturing, QA/QC, and IT teams to coordinate CQV activities and ensure seamless project execution. Provide technical input during project planning and scheduling of CQV activities. Track and report progress of CQV milestones, and support. Good knowledge in project management and excellent communication as well as writing skills

Skill Required Roles and Responsibilites 1. Media fill and qualification summary preparation knowledge. 2. To maintain track of qualification and validation activities. 3. To prepare and review the protocols and reports. Execution of various qualification / validation activities. 4. To review correctness of the technical documents received from the supplier (DQ/OQ/IQ/PQ,FAT). 5. Co-ordinate with production and other user department for qualification/validation activities 6. Timely compile and review of qualification validation reports. 7. To review the equipment documents like calibration reports and ensure correctness of documents. 8. To perform FAT. 9. To co-ordinate with outside agencies for execution of qualification activity whenever required. 10. Identification of deviation through review and observation. 11. To prepare annual Re-qualification/validation schedule, update VMP and Qualification related SOPs as and when required. Qualification Required B. Pharm/ M. Pharm/ MSC. Relevant skills / Industry experience 2 to 3 years experience in USFDA, MHRA, TGA approved plant

Use Your Power for Purpose Every day, everything we do is driven by an unwavering commitment to delivering safe and effective products to patients. Our flexible, innovative, and customer-oriented quality culture is rooted in science and risk-based compliance. Whether you are engaged in development, maintenance, compliance, or analysis through research programs, your contribution will have a direct impact on patients. Our dedication to quality and safety ensures that we consistently meet the highest standards, making a meaningful difference in the lives of those we serve. Join us in our mission to improve patient outcomes through excellence in every aspect of our work. What You Will Achieve In this role, you will: Evaluate, review, and approve validation master plans, protocols, and reports, ensuring compliance with regulatory requirements and company policies. Troubleshoot validation problems for equipment and performance processes, conducting statistical analysis of testing results to address process anomalies. Write, review, and approve validation process documents and technical reports related to equipment, products, and processes. Contribute to project tasks and milestones, organizing work to meet deadlines and applying basic team effectiveness skills within the immediate Work Team. Make decisions within limited options to resolve basic problems, working under the supervisors direction and seeking guidance from colleagues. Ensure work is regularly reviewed for technical judgment, completeness, and accuracy, exercising judgment with reliance on the supervisor. Determine the process capability of new equipment through the execution of approved protocols, incorporating defined parameters into operating procedures and batch records. Assist with the development of validation protocols, manage regulatory queries and responses, and participate in deviation investigations to identify root causes and define corrective and preventative actions. Adhere to all company and Good Manufacturing Practices (cGMP) procedures, safety regulations, and participate in the development of validation programs to stay current with cGMPs and industry standards. Work effectively as a member of the Quality Operations (QO) cGMP training team, collaborating with Business Area Training Leads, Coordinators, and SMEs to support cGMP and site training initiatives, reporting to the Validation Section Manager and summarizing data into concise reports for review and approval. Here Is What You Need (Minimum Requirements) Applicant must have a bachelors degree with 4 years of experience, or an associates degree with 4 years of relevant experience, or a high school diploma (or equivalent) and 6 years of relevant experience Excellent attention to detail and a solid understanding of Food and Drug Administration Regulations/Guidance and Good Manufacturing Practices Strong organizational skills and the ability to manage changing deadlines Proficiency in Microsoft Office, particularly Excel, for data evaluation Strong written and verbal communication skills Ability to work in a team environment and collaborate effectively with colleagues Basic understanding of validation principles and practices Bonus Points If You Have (Preferred Requirements) Technical writing experience, particularly within the pharmaceutical industry Laboratory process validation expertise Working knowledge of equipment qualification and calibration, especially for laboratory equipment Experience with regulatory queries and responses Excellent interpersonal skills and the ability to work collaboratively with cross-functional teams Adaptability and flexibility in a dynamic work environment Commitment to continuous learning and professional development Quality Assurance and Control

The Document Controller position at SEPAM in Chennai is a full-time on-site role that involves managing project documentation, records, and communication tasks related to document management. The ideal candidate should possess hands-on experience in GMP, Equipment Qualification, DQ/IQ/OQ/PQ, as well as experience in FMCG projects. Key responsibilities include document management, project documentation, and records management. The successful candidate will need to demonstrate strong communication skills, attention to detail, and organizational skills. Proficiency in document control software is essential for this role. Additionally, the ability to work effectively in a team environment is crucial. Candidates should hold a Bachelor's degree in a relevant field to be considered for this position.,

As an Assistant Manager/Manager- Quality Assurance, your responsibilities will include: - Reviewing and approving Standard Operation Procedures (SOP's) for all departments, ensuring timely completion of reviews and revisions according to the specified revision date. - Evaluating and approving analytical method validation protocols and reports, process method validation protocols and reports, water system validation protocols and reports, as well as equipment/instrument qualification protocols and reports. - Reviewing and approving raw material, packing material, semi-finished product, and final product specifications and test methods for analysis. Approving artwork and shade cards for printed packing material. - Overseeing and approving stability protocols and data. - Coordinating and supporting on-site audits conducted by customers and agencies, and implementing necessary corrective actions based on audit findings. - Developing, preparing, and implementing quality systems across the site. - Providing training to all staff members. - Reviewing and approving deviations, change control, and CAPA processes. - Planning and conducting internal audits for all departments. - Reviewing and approving batch manufacturing and batch packing records. - Ensuring the quality of manufactured products through an in-process quality assurance system. - Reviewing executed batch manufacturing records, batch packing records, finished product test reports with analytical data, and subsequently releasing batches for market distribution. - Ensuring data integrity compliance at the site. - Maintaining and improving product quality by conducting product, company, system, compliance, and surveillance audits, and investigating customer/market complaints. - Preparing FDA licensing documents, QA documents for export orders. - Creating quality documentation and reports by collecting, analyzing, and summarizing information and trends, including failed processes, stability studies, recalls, corrective actions, and re-validations. - Undertaking any additional responsibilities assigned by higher management as needed.,