220 Equipment Qualification Jobs

Role Overview: As a part of the engineering team, your role will involve preparing Equipment Qualification Protocols and performing Qualifications. You will be expected to understand, study, and develop user requirement specification for any automation project in the production department. Additionally, you will identify and prepare process improvements, prepare Process Validation Protocols, and perform Validations. Maintaining records as per WHO GMP / ISO requirements, training subordinates, and carrying out any other job assigned by your superior will also be part of your responsibilities. Key Responsibilities: - Understand, study, and develop user requirement specification for automation ...

As an Assistant Manager/Manager in the Quality Assurance department, your role will involve the following key responsibilities: - Review and approve Standard Operation Procedures (SOP's) for all departments, ensuring timely review and revision as per the revision date. - Review and approve various validation protocols and reports including analytical method validation, process method validation, water system validation, and equipment/instrument qualification. - Approve raw material, packing material, semi-finished product, and final product specifications and test methods for analysis. Also, approve artwork and shade cards for printed packing material. - Review and approve stability protocol...

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 ...

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

Responsibilities: Participate in management review meetings. Review of department trend analysis reports and internal studies or investigations. Ensure corrective action is initiated when required. Provide complete analysis of test results, investigation or information studies. Be capable of assuming study director responsibilities for all routine testing as well as certain advanced or specialized studies as requested by clients. Duties may include test scheduling, test preparation, proper application of test method(s), data collection, data review, and approval of final report of analysis. Maintain thorough knowledge and understanding of all SOPs pertaining to microbiology/sterility assuran...

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

We are looking for a skilled CSV Lead with 15-25 years of experience to join our team. The ideal candidate will have expertise in ServiceNow and HPALM. Roles and Responsibility Manage and implement CSV solutions using ServiceNow and HPALM. Collaborate with cross-functional teams to ensure seamless integration of CSV with other systems. Develop and maintain documentation for CSV processes and procedures. Troubleshoot and resolve issues related to CSV implementation. Provide training and support to end-users on CSV tools and features. Ensure compliance with industry standards and best practices for CSV management. Job Requirements Strong knowledge of ServiceNow and HPALM. Experience in managin...

Job Summary : Responsible for supervising and executing equipment operation, visual inspection, and packing activities in compliance with GMP and quality protocols. The role involves documentation, coordination with cross-functional teams, equipment qualification, and QMS adherence. Key Responsibilities : To perform equipment operation and cleaning To supervise visual inspection and batch packing execution as per plan To perform documentation as per batch record and SOP To perform equipment qualification as per protocols and SOP Responsible for maintaining documents as per cGMP norms Coordinate with cross-functional teams for day-to-day activities Responsible for SOP, MPR, and BPR preparatio...

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

Responsibilities: * Collaborate with cross-functional teams on equipment qualifications & CSV. * Ensure compliance with 21 CFR Part 11, IQ/OQ/PQ procedures. * Manage validation projects from planning to closure. Flexi working Work from home Over time allowance Travel allowance Food allowance Health insurance Annual bonus Retention bonus Job/soft skill training

Job Description JOB Responsibilities: - Location: Ahmedabad 1. Ensuring the GMP compliance at CMO and Release of batch manufactured for US market at CMU. 2. Monitoring of process starting from dispensing to packing including witness analysis of Lupin products manufactured at CMO for US market and Domestic market. 3. Handling of market complaint with root cause identification and ensuring the CAPA implementation. 4. New product review to be carried out at manufacturing site after availability of all the documents. 5. Review and authorize Master Batch Records, stability protocol, process validation protocol, temperature cycling protocol, specification of in-process, intermediate and finished p...

Responsibilities Formulation and filling in-charge Planning of Formulation and Filling area Indenting of raw materials from store Availability of raw materials, consumables required for Formulation and Filling area Maintain Raw and PPM inventory as per the production schedule Product changeover in Formulation and Filling Media fill simulation activity Coordinate with other department for equipment qualification / requalification / revalidation and equipment calibration activity Supervision of online documentation Review of documentation Preparation of new SOPs, Annexures, BMRs and summary protocols Awareness about deviation, investigation, change control, CAPA cGMP practices Heath hygiene Qu...

Job Title: Sr Officer – Production Business Unit: Sun Global Operation Job Grade G12B Location : Gangtok At Sun Pharma, we commit to helping you “Create your own sunshine” — by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine? As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.” Key responsibilities: To ensure operation & Preventive Maint...

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

Job Title Manager - Plant Engineering, Pharma Formulations Plant Maintenance Pharma Formulations Basic & Minimum Qualification Degree in Mechanical Engineering from a reputed university . Experience 12 to 15 years of working experience in a Pharmaceutical Formulations plant. Location: Ankleshwar Site. Job Description And KEY ACCOUNTABILITIES Engineering & Maintenance Operations Oversee preventive, predictive, and breakdown maintenance of plant equipment and infrastructure. Ensure optimal performance of manufacturing & packing, and warehouse equipment. Lead root cause analysis and corrective actions for equipment failures. Documentation and maintaining the History cards of all critical plant ...

Key Responsibilities: Overall looking for documentation work of Engineering Department and presenting as Engineering Q.A. Active Participation with Q.A in Audit Works. Active participation in QMS work i.e QAP and relevant documents for EU Audits. Scheduling, Planning, Executing Departmental working & documentation work for Engineering Drafting of QAP, SOP, Logbooks, Documents, etc and timely revision according to schedule. Drafting of Engineering SOPs for all machines/utilities accordance with manufacturer recommendations along with performing Qualification activities and accordingly designing logbooks and records. Drafting of In-house Qualification documents with respect to manufacturers do...

Role & responsibilities Key Responsibilities Lead Engineering & Utilities for sterile injectable formulation and filling operations. Manage cleanroom facility, equipment & utility design, qualification, and lifecycle management. Oversee Black & clean utilities WFI, Purified Water, Clean Steam, Compressed Air, HVAC, AHU, HEPA, LAF/RABS/Isolators. Implement robust preventive, predictive & breakdown maintenance programs. Ensure process automation SCADA, PLC, BMS, MES, and digital monitoring systems. Preparation & managing of CAPEX & OPEX for Engineering Section. Lead equipment qualification & process validation (IQ/OQ/PQ) and documentation. Maintain regulatory compliance USFDA, EMA, MHRA, WHO, ...

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 improveme...

Operation and Maintenance activities of utilities system, Installation, Modification, Repair, Planning and executing upcoming projects, online documentation and review of documentation as needed or requested by the organization. Job Responsibilities Ensuring and supporting to ARPL cross functional team or Uninterrupted supply of clean Utilities without any breakdowns and operates in full compliance with, all regulatory requirememnts and according to established safety norms. Ensure adherence to utility operation & maintenance procedures and good documentation practices are performed/followed all the time as per the established ARPL standards and maintain safe workplace at ARPL all time in co...

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

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

As the Packing and Visual Inspection Supervisor in the fill-finish area, your role involves overseeing the packing and visual inspection operations. Your key responsibilities will include: - Supervising overall packing and visual inspection operations in the fill-finish area. - Preparing and maintaining GMP documentation such as SOPs, BPRs, protocols, reports, and equipment qualification documents. - Ensuring all fill-finish packing equipment is installed, qualified, and maintained in operational condition. - Managing material inventory to ensure timely availability for packing operations. - Planning and executing batch packing activities according to production schedules. - Performing opera...

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

As a Sr Executive - Formulation at Dishman Carbogen Amcis Limited, located in Bavla, Gujarat, IN, you will be responsible for Equipment Qualification and IPQA Packing Validation. Key Responsibilities: - Conducting Equipment Qualification - Performing IPQA Packing Validation Qualifications Required: - Relevant experience in Formulation - Knowledge of Equipment Qualification processes - Familiarity with IPQA Packing Validation protocols Please note that there are no additional details of the company mentioned in the job description.,

Job Title Manager Biotechnology UPS Business Unit R&D1 Regulatory Affairs Job Grade G10 Location Baroda At Sun Pharma, we commit to helping you Create your own sunshine by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine As you enter the Sun Pharma world, you'll find yourself becoming Better every day through continuous progress. Exhibit self-drive as you Take charge and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we Thrive together and support each other's journeys. Job Responsibilities To perform DoE execution, analysis & interpretation ...