223 Equipment Qualification Jobs - Page 2

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 ...

Educational Requirements Bachelor of Engineering,Master Of Technology,Master of Pharmacy,Bachelor of Pharmacy,Bachelor Of Technology,Bachelor Of Science Service Line Application Development and Maintenance Responsibilities Key components of the responsibilities are as mentioned below but not limited to: 6+ yrs. of Professional experience and strong knowledge with real time experience in IT Quality & Compliance, Computer System Validation / Software Testing / System Implementation in the Life Sciences industry. Leads the effort to manage, and/or maintains validation of the GxP computerized systems. Create Validation Plan, Validation Report and Reviews validation documents such as URS, FS, FRA...

Educational Requirements Bachelor of Engineering,Master Of Technology,Master of Pharmacy,Bachelor of Pharmacy,Bachelor Of Technology,Bachelor Of Science Service Line Application Development and Maintenance Responsibilities Key components of the responsibilities are as mentioned below but not limited to: 6+ yrs. of Professional experience and strong knowledge with real time experience in IT Quality & Compliance, Computer System Validation / Software Testing / System Implementation in the Life Sciences industry. Leads the effort to manage, and/or maintains validation of the GxP computerized systems. Create Validation Plan, Validation Report and Reviews validation documents such as URS, FS, FRA...

Job Title: Manager Biotechnology UPS Business Unit: RD1 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 SunshineAs 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 o...

Job Description: Require experience in IPQA, IPQA (API), Qualification (API), Validation (API), Analytical QA, APQR, Stability Studies, regulatory affairs, OOS investigation, Risk Assessment, Market Complaint, QA Documentation, Exposure in QMS, Deviation, CAPA etc with Trackwise system. Qualification - B.Sc./M.Sc./ B.Pharma/ M.Pharma. Experience - 04 to 09 Years. Role & responsibilities Preferred candidate profile The candidate from API background Only to apply. Send CV with Sub : Forwarding CV for position of QA dept to jagpal.dewal@ipca.com

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...

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...

Diploma / BE (ECE EEE). Responsibility : Assist in operation maintenance of engineering utilities such as HVAC, Water System, Boiler, Chiller, air Compressors, nitrogen plant distributions systems and DG sets. Support in preventive, predictive, and breakdown maintenance activities. Participate in equipment qualification and validation (IQ, OQ, PQ) and related documentation. Assist in project execution, equipment installation, and commissioning. Ensure compliance with GMP, cGMP, and regulatory requirements in engineering operations. Monitor and maintain engineering records, logbooks, and SOPs. Coordinate work with cross-functional teams to support production and quality requirements..

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. ...