223 Equipment Qualification Jobs - Page 5

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 qua...

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 ...

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...

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 ...

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. ...

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, WH...

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 ...

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 I...

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 cru...

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 printe...

We are looking for a meticulous Junior Engineer to contribute to the efficient maintenance and operation of our API manufacturing facility at Synnat Pharma. As a Junior Engineer, you will be integral to ensuring the reliability of our mechanical and electrical systems, contributing to our commitment to quality and compliance. This role involves a blend of hands-on equipment maintenance, detailed record-keeping, and active participation in equipment validation and qualification processes. You will collaborate closely with senior technicians and engineers, assisting in breakdown maintenance, equipment installation, and process improvement projects. Your dedication to following safety procedure...

Gurugram Job ID: SS202500088 Function: Lab Testing Role: Lab Desired Skills: Lab Testing, Calibration, Product/Protype Testing,IQ,OQ,PQ,DLP,DGP,5S Job Description Mechanical testing & analysis of products/prototypes ? Test planning & scheduling for multiple projects ? Sample preparation & test equipment setup ? Equipment operation, preventive maintenance & troubleshooting ? Equipment qualification (IQ, OQ, PQ) ? Calibration execution & vendor results review ? Root Cause Analysis (RCA) ? Preparation & review of SOPs, WIs, and test protocols ? Compliance with GLP, GDP & 5S standards ? Safety procedures & hazard control ? Experiment planning & coordination with internal/external labs ? Support ...

KWALITY PHARMACEUTICALS LTD. 6 , MILE STONE, VILL. NAG KALAN, TH MAJITHA ROAD, AMRITSAR , PUNJAB 143601 (INDIA) About Our Organisation : Kwality Pharmaceuticals Ltd. is a manufacturer of finished pharmaceutical formulations in a dosage form. The company was incorporated on May 4 1983, and is ever progressing in Domestic and International markets. Kwality Pharma was Incorporated on May 4th 1983 by Mr. Ramesh Arora ( Founder ) of the company . Our company is based on its commitment to high quality and timely supplies. Kwality Pharmaceuticals Ltd are leading manufacturer & exporters of pharmaceutical formulations in Liquid Orals, Powder for Oral Suspension, Tablets, Capsules, Sterile Powder for...

Educational Requirements Master of Pharmacy,Master Of Technology,Bachelor of Pharmacy (Honors),Bachelor Of Science,Bachelor of Engineering,Bachelor Of Technology 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...

You should have a background in B.Pharma / M.Sc. and preferably from the Pharma industry. It is mandatory to have experience in both Sterile & Non-Sterile processes. Experience in Regulatory markets such as USFDA, MHRA, EU is required, with USFDA being the first preference. The offered CTC for this position is 30 LPA and a minimum of 15 years of experience is necessary. Both male and female candidates are welcome to apply. Your responsibilities will include having a strong understanding of Cleaning Validation, Process Validation, Equipment Qualification, and Computer System Validation. You will be in charge of managing 4 units within the Indore Site. Strong team management and communication ...

The Regulatory and Quality Manager role in Noida requires a female candidate and involves various responsibilities related to quality management and regulatory compliance. You will be responsible for implementing the Quality Management System in alignment with regulatory requirements. This includes managing regulatory documentation and overseeing the Continual Improvement of Systems, Product Quality Review Process, Corrective and Preventive Action System. Your accountability extends to ensuring data integrity and implementing SOPs and policies. You will evaluate and approve master documents across different departments and prepare and approve various master documents such as BMR, SOP, STP, S...

The primary goal of this position is to oversee the smooth operation and maintenance of plant and utilities automation activities, ensuring effective maintenance practices, spares management, budget control, equipment redundancy, equipment qualification, and education and capability building for a team of technicians. The major responsibilities of this role include ensuring maximum availability of utilities equipment, trouble-free operation of utilities, availability of spares/consumables, and inventory meeting critical maintenance requirements. Additionally, the role involves initiating and implementing cost reduction measures to reduce maintenance costs, ensuring compliance for calibration...

The responsibilities for this role include reviewing raw and finished product specifications, ensuring good laboratory practices in the Quality Control department, reviewing audit trial records, analyzing analytical records, reviewing instrument calibration and equipment qualification documents related to QC, validating analytical methods, verifying samples, handling reserve sample room, ensuring analyst qualification, reviewing working standards, managing deviations, change control, OOT, OOS, laboratory incidents, investigations, and annual trends, coordinating CAPA implementation verification and closure, reviewing instrument and equipment preventive maintenance, monitoring and recording t...

Seeking a CSV Consultant to work on a variety of validation projects including manufacturing systems, lab systems, risk assessments, etc. Some of the work may be done remotely, some at client sites and others at one of our offices. Immediate start date Job Responsibilities: Responsible for the Computer System Validation processes of the company Maintain expertise in current and emerging cGMP requirements and quality trends (e.g., 210, 211, 820, and 21 CFR Part 11) Work independently on and successfully solve problems and complete/qualify a system within given constraint of scope, time and schedule Lead system qualification efforts and be the primary client contact for coordinating work, repo...

To prepare and review Validation Master Plan QMP, VMP, PVMP, Handling and storage of all quality document like BMR, investigation. CAPA and all other quality management, CAPA Monitoring of PPQ, requalification activities, OSD

As a Sr. Executive / Assistant Manager Quality Assurance (QA) at SAVA Healthcare Limited, Surendranagar Plant, your primary responsibility is to ensure the implementation and maintenance of cGMP practices, quality systems, and compliance with regulatory requirements. You will oversee QA activities including documentation, validations, audits, and shop floor compliance to uphold product quality and regulatory adherence. Your key responsibilities will include ensuring compliance with cGMP, SOPs, and regulatory requirements on the manufacturing floor, reviewing and approving batch manufacturing records (BMRs) and batch packing records (BPRs), handling deviations, change controls, CAPA, and qual...

IQ, OQ and PQ,execution of Facility, Utility, Equipment and Computer system qualification,Client schedules,Report daily activities and work completion status to Sr. Manager, Validation ,SOPs Validation, Qualification,Calibration activities

As a Production Plant Operator/Technical Assistant at Zydus Lifesciences Ltd's SEZ 1 OSD Manufacturing Unit in Ahmedabad, you will be responsible for operating and maintaining equipment used in granulation, compression, coating, and capsule filling processes. For the Production Staff position, we are seeking individuals with a B.Pharm/M.Pharm qualification and 4-10 years of experience in market complaints handling and documentation. As a member of the Packing Staff, your role will involve managing packing operations with a focus on quality assurance. Candidates with a B.Pharm/M.Pharm qualification and 4-10 years of experience are encouraged to apply. Quality Assurance IPQA professionals with...

: Review of R&D developmental data of ARD and PD like Method Development Reports, Method Validation Reports, Characterization Reports, Product Development Report, Study Reports, for accuracy, data integrity and compliance to systems, procedures and regulatory requirements. Review of Technology Transfer documents like Method Transfer protocol/Reports, Master Formula Records, Master Packaging Record, Stability Study protocol, Specifications and MOAs. Conducting routine laboratory rounds for ensuring compliance to Good Laboratory Practices. Handling of Change Controls, Deviations, Incidents and Laboratory Assessment Reports. Preparation, review of SOPs and conducting the SOP Training. Conductin...

Roles and Responsibilities Responsible to design validation/ qualification strategies. Responsible for validation /qualification of processing equipment's, cleaning equipment's and testing equipment's on time. Responsible to review & approve of validation /qualification protocols and reports. Responsible for day to day validation planning and execution activity. Planning, Execution & Participation of aseptic process simulation activity. Responsible for process validations, hold time studies, thermal studies, transport validation, filter validation etc but not limited. Responsible to design, review, approve and implementation of departmental standard operating procedures. Responsible to revie...