288 Equipment Qualification Jobs - Page 8

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...

The Company Syngene International Ltd. is an integrated research, development, and manufacturing solutions company serving various sectors including pharmaceutical, biotechnology, nutrition, animal health, consumer goods, and specialty chemicals. With a team of over 4500 scientists, Syngene offers expertise in delivering high-quality science, robust data management, IP security, and efficient manufacturing processes. The company's facilities span over 1.9 million square feet, catering to leading biotech companies and multinational corporations such as GSK and Merck KGaA. Key Responsibilities Safety is a top priority at Syngene, and all employees are expected to prioritize safety in both pers...

Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company dedicated to developing innovative products to serve underserved patients. With a focus on providing unique, accessible, and high-quality medications, Azurity continuously expands its commercial product portfolio and late-stage pipeline by leveraging integrated capabilities and a vast partner network. The company's patient-centric offerings span various markets including cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, positively impacting millions of patients. As an inclusive workplace and Equal Opportunity Employer, Azurity attributes its success to a team of talente...

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...

Hiring for the role of Documentation Job Title: Documentation Level Executive / Sr. Executive Experience: 3-5 Years Location: Ankleshwar Job Summary: The Documentation Engineer will be a key member of the execution team, responsible for managing and maintaining documentation related to installation, commissioning, and qualification of process and utility equipment. This role is ideal for mid-level professionals (3-5 years of experience) looking to advance their expertise in installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) for equipment used in pharmaceutical, chemical, and food processing industries. Key Responsibilities: Prepare and maintai...

Job Description :- Maintenance Officer / Sr. Officer Scicore Nutra Private Limited is a state-of-the-art facility, located in Sanand Gujarat, is dedicated to producing high-quality nutrition products that are safe, effective, and meet the highest standards of quality. Our team of experts is committed to ensuring that every product we manufacture is produced with the utmost care and attention to detail. At our manufacturing unit, we use only the best raw materials and employ advanced manufacturing processes to ensure that our products are of the highest quality. We also adhere to strict quality control measures to ensure that every product meets our rigorous standards. This starts with doing ...

1. Responsible for preparation of Validation Master Plan, validation related SOPs and schedules. 2. Responsible for preparation of facility, equipment, area qualification protocols and reports. 3. Responsible for execution of facility, equipment and area qualification activities. 4. Responsible for compilation and review of validation raw data and test certificates. 5. Responsible for preparation and review of Computerized system validation (CSV) documents and execution of CSV for equipments. 6. Responsible for preparation of User Requirement Specification, Design Qualification, FAT protocols, SAT protocols, Installation qualification, Operational qualification and Performance qualification,...

Therapy expertise: Antidiabetics, preferably modern non-insulin antidiabeticdrugs like DPP4i, GLP1-RAs, SGLT2i etc. Key Responsibilities: 1. Brand Execution Market Adaptation Assist in implementing brand positioning and messaging for the Cardiac therapy portfolio, aligning with global guidelines. Conduct market research to understand therapy trends and competitive landscape. Adapt global marketing strategies for local markets while ensuring compliance and accuracy. 2. Promotional Campaign Development Support the creation of marketing collaterals such as brochures, flyers, digital assets, and promotional materials. Coordinate with creative teams to develop high-quality campaigns. Assist in ex...

We are looking for a skilled Kneat CSV Professional with 6-12 years of experience to join our team at IDESLABS PRIVATE LIMITED. The ideal candidate will have a strong background in Recruitment / Staffing and excellent skills in Kneat CSV. Roles and Responsibility Manage and implement Kneat CSV solutions for clients. Collaborate with cross-functional teams to identify and prioritize project requirements. Develop and maintain technical documentation for Kneat CSV projects. Provide training and support to clients on Kneat CSV tools and features. Troubleshoot and resolve issues related to Kneat CSV implementation. Analyze and optimize client data processing workflows using Kneat CSV. Job Require...

Roles and Responsibilities Conduct HVAC qualification activities, including cleaning, testing, and validation of equipment. Perform area validation and cleanroom validation to ensure compliance with regulatory requirements. Ensure proper documentation of all validation protocols, reports, and results. Collaborate with cross-functional teams to identify and resolve issues related to HVAC systems. Maintain accurate records of maintenance schedules, repairs, and inspections. Desired Candidate Profile 1-5 years of experience in HVAC qualification or a related field (e.g., mechanical engineering). Diploma or B.Tech/B.E. degree in Mechanical Engineering or equivalent. Strong understanding of commi...

Role & responsibilities Responsible for defining QA strategy, approach and execution in the field of document control, IPQA, qualification/validation, GLP, training activities etc. and responsible for leading and directing QA team To approve SMF, VMP, quality manual and validation protocol. To conduct internal audit / self-inspection to ensure compliance to GMP and another regulatory requirement. To arrange management review meeting and escalate the outcome of quarterly report to management. To handle the Market Complaints and to participate in Product Recall. To approve quality system documents likes Change controls proposals, Deviations, Incident reports, CAPA reports, OOS and OOT, NCR, Ma...