223 Equipment Qualification Jobs - Page 6

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...

As a Deputy Manager at Syngene International Ltd., your main responsibility will be handling QMS documentations like CC, CAPA, and Investigations, as well as managing EDMS documents, study protocols, and qualification protocols. You will be in charge of performing activities related to Engineering & maintenance at Biologics Unit 03 while ensuring GMP compliance and error-free operations. It will be crucial for you to follow all EHS requirements at the workplace to ensure individual and plant safety. Your role will involve completing all assigned mandatory trainings related to data integrity, health, and safety measures on time, and ensuring compliance to quality systems and current good manu...

Job Title: GLP-Quality Assurance Personnel Location: Bangalore, KA, IN, 560099 Syngene International Limited, Bengaluru is an innovation-led contract research, development, and manufacturing organization offering integrated scientific services from early discovery to commercial supply. At Syngene, safety is a top priority, with a focus on ensuring safety guidelines, procedures, and SOPs are followed diligently. As a GLP-Quality Assurance Personnel at Syngene, you will play a crucial role in aligning laboratory practices with Good Laboratory Practice (GLP) guidelines to maintain the integrity and reliability of non-clinical safety and clinical studies. You will also work in a regulatory envir...

The role we are offering is for a Block Head to lead a key production block within our injectable manufacturing facility. Your responsibilities will include overseeing end-to-end manufacturing operations, managing a team of production staff, driving process optimization, ensuring regulatory audit readiness, maintaining compliance with cGMP standards, implementing changes, overseeing equipment and maintenance, coordinating cross-functionally, and managing inventory and resources. You should have a degree in Pharmacy, Engineering, or a related field, along with proven experience in sterile/injectable manufacturing. Strong leadership and team management skills are required, as well as knowledge...

JD: -Knowledge of rotating & static equipment maintenance. - Knowledge of Gas fire boiler & coal fire boiler (8 Ton) - Knowledge of brine plant chilling, reciprocating Kirlosker make & Refrigerant ammonia. - Knowledge of Air compressor, Nitrogen plant, cooling tower, DM Plant, softner plant. - Equipment qualification & documentation. - Manpower Handling. - Shutdown planning & scheduling & BOQ preparation.

Detailed job description - Skill Set: Technically strong hands-on Self-driven Good client communication skills Able to work independently and good team player Flexible to work in PST hour(overlap for some hours) Past development experience for Cisco client is preferred.

Witnessing of manufacturing processes for sterile drug products including cleaning, sanitization, environmental monitoring and personnel monitoring to ensure compliance with CGMP regulations and regulatory standards Oversight of cleanroom behavior, contamination control and aseptic techniques To report any observations to site operations and quality and ensure compliance to the observations Review of media fill protocol and reports and witnessing aseptic process simulations Review of batch documentation to ensure product quality, regulatory compliance and meeting ALCOA++ requirements Review of environmental monitoring reports Review of unplanned deviations and CAPA

Witnessing of manufacturing process (mixing, granulation, blending, compression, coating, capsule filling) & packing (primary/secondary packaging) for solid oral products to ensure compliance with current Good Manufacturing Practices (cGMP) and regulatory expectations. Oversight of line clearance, equipment and area cleanliness, material verification, and adherence to SOPs. Ensure compliance with data integrity (ALCOA++) standards in all documentation and records related to production and QA oversight. Review of batch documentation to ensure product quality and regulatory compliance. Review of unplanned deviations and CAPA. Review of environmental monitoring data Collaborate with site operat...

Role & responsibilities Analyze U.S. generic market opportunities using IQVIA, FDA databases, Orange Book, and competitive intelligence tools Identify and prioritize products based on market size, competitive landscape, development feasibility, and potential profitability Conduct patent, exclusivity, and litigation analysis (Paragraph IV, FTF opportunities) Work closely with R&D, Regulatory, Legal, and Supply Chain to ensure selected products align with internal capabilities Track product development pipeline and communicate risks or bottlenecks Prepare business cases and forecasting models for executive decision-making Preferred candidate profile: Bachelor's or Masters in Pharmacy, Life Sci...

Job Description Physical verification and readiness of equipment and instrument for process. Arranging the process accessories and consumables in process area before batch execution. Coordination for dispensing of raw material required for the production processes. Preparation of process, equipment and area related SOPs and EOP s. Preparation of process, area and equipment qualification/ validation protocols. Preparation and execution of various reports like process, equipment, area qualification and validation. Request and Issuance of BPR. Preparation and review of BPR. Preparation and execution of study protocols, URS as and when required Work Experience 4 to 7 Years in Downstream processi...

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

1. Planning and preparation of qualification protocols and documents for equipment, instruments, systems, including of utilities, manufacturing process, packing equipment. 2. Review, execution and compilation of qualification protocols and documents for equipment, instruments, systems, including of utilities, manufacturing process, packing equipment. 3. Preparation of yearly and add-on schedule for Periodic Performance Verification-Performance Testing (PPV-PTS). 4. Preparation of yearly and add-on schedule for Periodic Performance Verification-Support Programme Review (PPV-SPR). 5. Follow and ensure compliance of validation SOPs, policy documents and written procedures. 6. Follow and ensure ...

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...

1 Supervise & Monitor manufacturing and packaging activity. 2 To guide, supervise, co-ordinate, manage and lead a team of production officer and production operators in execution of manufacturing operation to achieve the stated goals. 3 Preparation, review and implementation of SOPs and Formats pertaining to manufacturing Department. 4 Preparation and review of URS for manufacturing department. 5 Imparting training of manufacturing SOPs and GDP to Production Operators and Production Officers. 6 Preparation and review of Performance Qualification batch record and protocol. 7 Executing and reviewing of manufacturing equipment qualification activity. 8 Execution and supervision of the Process V...

Brief team/department description: The Analytical Development department in the science organization at Azurity Pharmaceuticals is responsible for developing new analytical methods for the new dosage forms to ensure their quality. Principal Responsibilities: Responsible for the development of analytical methods for product development, primarily for sterile dosage forms and/or oral dosage forms. Responsible for the preparation of method development reports, validation protocols and reports, and test methods. Accountable for performing routine analytical testing for assigned projects, as per requirements. Responsible for executing Analytical ATR (Analytical Testing Reports), documenting resul...

Executive-CQA-VQG 1. To perform and track the Vendor Qualification Compliance and review for all vendors & AVDs. 2. To review, approve, and extend the Q info for new alternate vendors. 3.To execute vendor Audits, CAPA tracking, and qualification documentation 4.To schedule and monitor the Vendor Audits 5.To work on VQ special projects in coordination with Project IT team 6.To track the project till its implementation and Go Live across all sites Competencies 1. Strategic Agility 2. Innovation & Creativity 4. Developing Talent 3. Customer Centricity 5. Result Orientation Education Masters in Chemistry Post Graduation in Pharmacy 5-8 YearsWork Experience