288 Equipment Qualification Jobs - Page 5

Description 1. Ensure Review and Approval of planning, execution and documentation of Change Management Activities (at Asses / Review states); along with associated lifecycle documents and test documents for Change Lifecycle by maintaining the IT Compliance standards. 2. Responsible for the review and approval of Test Scripts and executed test cases to assure compliance with good documentation practices. 3. Individual contributor for Quality, Compliance, and Good Documentation Practices 4. Experienced in authoring review of validation documentation such as URS, FRS, and SDS, Validation Plan, Issues Log, Design Review, IQ Protocol/Report, OQ Protocol/Report, Test Cases, Test executions, Trace...

As a Biopharmaceutical Manufacturing Specialist, you will be responsible for hands-on execution of manufacturing processes in both upstream and downstream operations. This includes working with single-use bioreactors, media preparation systems, AKTA systems, chromatography columns, UF/DF systems, buffer preparation units, virus filtration, and other single-use technologies. Your main focus will be to ensure batch operations are conducted in compliance with cGMP guidelines, maintaining strict adherence to quality standards and regulatory requirements. Key Responsibilities: - Conduct batch operations in compliance with cGMP guidelines - Maintain and support Quality Management Systems activitie...

Role & responsibilities 1. Responsible for review of User Requirement Specification, Design Qualification, FAT Protocols, SAT Protocols, Installation Qualification, Operational Qualification, Performance Qualification Protocols and reports. 2. Responsible for preparation of commissioning protocols, FAT, SAT and associated risk and GAP analysis documents. 3. Responsible for preparation of facility, equipment, area qualification protocols, reports and execution. 4. Accountable for ensuring the compliance the qualification activities in -line with global quality/regulatory requirements. 5. Responsible for Engineering compliance and review of Engineering department SOPs, PMP calibration and faci...

Job Title: Deputy Manager- Formulation Location: Govandi, Mumbai Department: Corporate Quality Assurance Qualification, Experience and Technical Competency: 1. Master’s Degree in Pharmacy or Science or equivalent scientific field. 2. Minimum 10 years experience in Pharmaceutical Industry (Strong background of Formulation industry with 2 to 3 years experience in Quality Control.) 3. Work experience in Regulatory Sites (USFDA, MHRA, EU GMP) 4. Knowledge of current Good Manyfacturing Practices (cGMP), Quality Management Systems (QMS) and regulatory guidelines. Key Requirements: Responsible for Quality Functions across Own Sites and Contract Sites with adherance to cGMP, Regulatory standards and...

As a Process Equipment Engineer, you will be responsible for designing and specifying process equipment systems for pharmaceutical manufacturing plants, ensuring alignment with project goals and regulatory standards. This includes selecting appropriate equipment based on factors such as material compatibility, process requirements, automation, and cost-effectiveness. Additionally, you will develop equipment specifications, datasheets, and technical documentation for procurement and installation. - Design and specify process equipment systems for pharmaceutical manufacturing plants. - Select appropriate equipment based on material compatibility, process requirements, automation, and cost-effe...

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 documents. Co-ordination...

Supervise overall packing and visual inspection operations in the fill-finish area. Prepare and maintain GMP documentation , including but not limited to SOPs, BPRs, protocols, reports, and equipment qualification documents . Ensure all fill-finish packing equipment are installed, qualified, and maintained in operational condition. Manage material inventory and ensure timely availability for packing operations. Plan and execute batch packing activities in line with production schedules. Perform operation, verification, calibration, and cleaning of weighing balances (1.5 kg). Oversee labelling, packaging, and visual inspection activities , ensuring accuracy and compliance with GMP. Conduct vi...

Responsibilities: To impart the departmental training & co-ordinate for cGMP training as per planned schedule. To Coordination of Regulatory/Customer audit and its compliance. Review the audit feedback and provide the action plan for compliance of audit observation/ findings. To perform self-inspection for all respective departments & evaluate the compliance of any reported non-compliance in the self-inspection report. To review the deviation, change control, incident for impact on product quality and safety in QAMS. Perform risk assessment for risk reduction/mitigation at acceptance label for product & QMS related documents as part of impact assessment. Review of QA documents, review of spe...

Job Title: Senior Officer – Process Engineering Business Unit: Engineering 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: Execution of Breakdown maintenance...

Who We Are Together, we're on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It's a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world's leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization's Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we're always looking for new ways to continue making a difference, and new people to make a difference with. Ho...

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...

Roles and Responsibilities Ensure compliance with regulatory requirements for equipment qualification, utility qualification, area qualification, transport validation, smoke testing, injectables, sterile, injection, vial washing, isolators, insulators, terminal sterilizer, RABS, Automatic leak testing machine chambers. Utility qualification (HVAC, WFI, PW etc), Facility and Area Qualification. Air flow visualization study (Smoke study) Develop and implement effective QA procedures to maintain high standards of production. Collaborate with cross-functional teams to resolve quality issues and improve processes. Maintain accurate records of all QA activities, Prepare and develop IQ,OQ,PQ & RQ p...

Role & responsibilities Location: Bidar, KA Role: Sr QA Lead JOB DESCRIPTION: 1) Handling of Quality management system. 2) Monitoring Process validation program. 3) Handling of customer and regulatory audits. 4) Monitoring Equipment Qualification program. 5) Coordinate with cross functional team to provide audit response to customer and regulatory agencies. 6) Conducting internal audits as per schedule. 7) CAPA effectiveness verification. 8) Conducting Quality review board meetings and management review meetings as per schedule. 9) Monitoring Equipment cleaning program. 10) Providing necessary documents to address Regulatory Queries, amendments, annual updates and regulatory filings and CMC ...

Roles and Responsibilities 1. Responsible for implementation & monitoring of cGMP/GDP practices at site. 2. Responsible for periodic review of all quality Documents for appropriateness. 3. Preparation of SOPs and handling of QMS tools like deviation change control, CAPA. 4. Responsible for approval/rejection of deviations /change controls pertaining to corporate activities. 5. Oversee the team of technical personnel handling order processing artworks finalization BOM updating of products and follow ups. 6. Responsible for co-ordination and submission of Quality documents for regulatory submissions. 7. Responsible for maintenance, periodical update and review of technical agreements with dome...

Roles and Responsibilities Conduct market complaint investigations, deviation management, and OOS/OOT handling according to established procedures. Ensure compliance with regulatory requirements through vendor qualification, equipment qualification, cleaning validation, water validation, injectable processing, and process validation. Collaborate with cross-functional teams to resolve quality issues and implement corrective actions. Develop and maintain documentation related to quality control processes. Provide technical support for product testing and analysis. Desired Candidate Profile 4-8 years of experience in Quality Assurance (QA) or a related field within the pharmaceutical industry. ...

Job title: Sr. Executive - Plant Engineering , Pharma Educational Qualification. Bachelor's Degree (B.E.) in Mechanical / Instrumentation Engineering from a reputed college. Work Experience 8 to 10 years of working experience in Pharmaceutical Formulations Key Accountabilities Responsible for troubleshooting and breakdown maintenance of packing equipment (Blister packaging and cartonator, serialization machines), and minimizing equipment downtime. Corrective & Preventive maintenance to eliminate recurring failures in the equipment. Execution of monthly / Quarterly and Annual Preventive maintenance of the equipment and operating the same to achieve the target of 100% completion against the sc...

Introduction: Jubilant Bhartia Group is a global conglomerate founded by Mr. Shyam S. Bhartia and Mr. Hari S. Bhartia with strong presence in diverse sectors like Pharmaceuticals, Life Science Ingredients, Contract Research & Development Services, Therapeutics, Performance Polymers, Food Service (QSR), Food, Auto, Consulting in Aerospace and Oilfield Services. Group has global presence employing around 42,000 people across the globe with over 2,400 in North America. Jubilant Pharmova Limited Jubilant Pharmova Limited (formerly Jubilant Life Sciences Limited) is a company with global presence that is involved in Radiopharma, Allergy Immunotherapy, CDMO Sterile Injectables, Contract Research D...

Responsible to harmonize, ensure and standardize policies and procedures for computerized system validations and ensure effective implementation of the computerized system validation in coordination with corporate quality and with all departments of the plant with respect to Computer System Validation (CSV) Responsible to assist site personnel/management in developing protocols, test cases, validation packages, etc for validations of computerized system Responsible to evaluate validation requirement for computerized systems used for GxP purposes in various department of the plant Provide guidance on the interpretation of regulatory requirement and guidelines for GxP Computerized systems from...

We have urgent Requirement for : Department : Quality Assurance Designation : Executive Skills Required : Process Validation, Equipment Qualification, QMS, APQR, Capa, Cleaning Validation. Experience Required : 03 to 08 years Salary : Depend upon Interview Location : Nalagarh interested candidate can contact @ 7717304694 or can send their Resume at hr2@theonpharma.com

Job Description Candidate should have sound knowledge about upstream process development (Cell culture and Fermentation). Hands on experience of shake flask studies including sample analysis and documentation. Experience in handling and operation of cell culture and microbial related experiments in bioreactor including sample analysis and documentation. Aseptic handling of seed inoculum and its maintenance Independently handle media and feed preparation for conducting studies. Should be able to trouble shoot in case of any deviation from process/parameter. Good documentation practice. Should be able to perform cell culture (IPQC) analysis. Preparation of SOP, Support for Equipment qualificat...

Job Description Position: QA Sterile Manager Department: Quality Assurance Designation: Manager - I Education Qualification: M.Sc. in Biotechnology / Microbiology / Chemistry Total years of Experience: 10+ Years Job Role: Management of Quality Assurance functions of Manufacturing Block P. Responsibilities Ensure that manufacturing and packing of the batch is executed and records are completed and reviewed in accordance with established SOPs and cGMP regulations. Conduct certification of batch production records for compliance and stage-wise completion. To release / reject the Batch after complete review of batch and related quality documentation. Tracking and monitoring of QMS system. Ensure...

As a Production and Manufacturing Specialist, you will play a crucial role in ensuring the smooth functioning of production activities. Your key responsibilities will include: - Preparing work instructions for Production and manufacturing activities. - Carrying out production activities as per the production plan. - Monitoring the batch process to maintain efficiency. - Maintaining online documentation related to production activities like BMR, BPRs, logbooks, and daily records. - Qualification of production equipment and active participation in validation activities. - Taking line clearance at various stages for a streamlined process. - Issuing requisitions to the store department for Raw m...

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...

Role & responsibilities: Outline the day-to-day responsibilities for this role. Preferred candidate profile: Specify required role expertise, previous job experience, or relevant certifications.

Role & responsibilities : Equipment Qualification DPI liquid Injection Cleaning Validation Ampoule ,Vial Washing Media Fill Leak Test Line Clearance In Process Validation( Related to sampling ) Dental cartridge BMR/BPR