7 Qms Activities Jobs

Job Description: As a QMS Project Reviewer at Syngene International Limited in Bengaluru, you will play a vital role in drug substance development and manufacturing processes. Syngene is an innovation-led contract research, development, and manufacturing organization that offers integrated scientific services from early discovery to commercial supply. Safety is a top priority at Syngene, and you will be expected to adhere to safety guidelines, procedures, and SOPs to ensure a safe working environment for yourself, your team, and the lab/plant. Your core responsibilities will include following GMP, GDP, and GLP procedures, creating/revising/reviewing procedures such as SOPs and protocols, reviewing and approving Master BMR and PDR, and ensuring compliance. You will also be responsible for verifying product details, conducting assessments, investigating deviations, and handling returned products and product recalls. This role presents an exciting opportunity to interact with clients globally, collaborate with cross-functional departments, and gain exposure to various aspects of product development and commercial manufacturing. You will be expected to demonstrate expertise in handling QMS activities, reviewing Master Batch Record and Analytical Documents, and maintaining good communication and coordination skills among cross-functional teams. To be successful in this role, you should have 3-6 years of experience in project-related QMS activities, experience in client handling, and a strong educational background with an MSc in Chemistry. Additionally, you should possess good knowledge of Good Documentation and laboratory practices, as well as excellent skills in reviewing specifications and methods of analysis. At Syngene, we value excellence, integrity, and professionalism, and we are committed to providing equal opportunities for all employees. Join us at Syngene and be a part of our mission to deliver high-quality scientific services while maintaining a strong focus on safety and compliance.,

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 environment to ensure compliance with national and international standards set by organizations such as OECD, FDA, ICH, and ISO. Key Responsibilities: - Ensure compliance with OECD principles of GLP, ICH, and WHO-GCLP - Handle inspections and audits - Manage QMS activities including change controls, deviations, and CAPA - Review SOPs, study plans, and documentation related to QAU - Conduct inspections of studies, facilities, and processes in analytical and bioanalytical domains - Audit raw and electronic study data and reports - Review equipment and computerized system qualifications as per OECD Principles 17 and 21 CFR Part 11 Requirements: - Experience: 6-9 years - Knowledge of GLP principles as per OECD, ICH, FDA, and EPA guidelines - Proficiency in handling QMS activities - Ability to review SOPs and study plans for regulatory compliance - Understanding of data integrity policies and standards - Skilled in conducting inspections and audits - Competent in preparing and reviewing QAU documentation and SOPs Skills and Qualifications: - Master's degree in Pharmacology, Chemistry, or related field - Proficiency in handling multiple software applications and tools - Strong problem-solving skills with a scientific mindset - Ability to work collaboratively in a team environment - Excellent communication skills Syngene Values: - Excellence - Integrity - Professionalism Syngene is an equal opportunity employer dedicated to providing a safe and inclusive work environment for all employees.,

You will be joining USV Private Limited, a leading pharmaceutical company in India known for its expertise in the diabetes and cardio sectors, with a global presence in over 65 countries. Your role will be in the Biologics function, specifically as an Assistant Manager or Manager in Regulatory Affairs (Clinical Trials) focusing on the EU and US markets. You will be based in Govandi (East), Mumbai, with a work schedule that includes working on the 1st, 3rd, and 5th Saturdays, while having the 2nd and 4th Saturdays off. To be considered for this position, you should have a qualification of M.Pharm/B.Pharm along with 5-15 years of relevant work experience in Regulatory Affairs-Clinical Trials for the EU and US markets. As part of your responsibilities, you will be involved in developing the Biosimilar Clinical Development Strategy, overseeing clinical trials and injectables for the EU and US markets. You will also be responsible for designing and finalizing clinical protocols, as well as managing Clinical Trial Applications and reviewing Clinical Study reports. Additionally, your role will include authoring and reviewing Biologics/Biosimilar Dossiers, with hands-on experience in eCTD submissions for the EU and US markets. You will handle Ministry of Health (MOH) queries, contribute to Product Life Cycle Management, and provide Regulatory Affairs support for plant-related Quality Management System (QMS) activities.,

Role & responsibilities Position: Executive/Sr.Executive-Mechanical -Installation & Commissioning 1No Qualification: B.E/Diploma in Mechanical with 3 to 4 Years exp. 1. At least 3 years handling Experience on Bio-pharmaceutical Projects / Maintenance / Operations or in Project Consulting firms. 2. Hands on Experience on Execution of Equipment Installation & Commissioning Activities 3. Hands on Experience on Clean & Black Utility systems installation, commissioning & Qualification 4. Experience in process drain piping, external pipe rack systems installation & commissioning. 5. Responsible for construction quality and commissioning readiness of various utility systems. 6. Preparation, Review of Mechanical components technical specifications. 7. Responsible for execution of projects with an internal team and in coordination with consultants/contractors. 8. Preparation/Review of documents URS, P&ID, DQ, FAT, SAT, IQ, OQ. 9. Responsible for executing commissioning & qualifications (FAT, SAT, IQ, OQ) for all Clean utility systems in coordination with vendors/contractors and users. 10. Responsible for ensuring the execution of preventive and breakdown maintenance of all equipment as per applicable SOPs and Good Engineering Practices. 11. Responsible for safety compliance during construction & execution phase of project. 12. Responsible for preparation and review of engineering related & Utility System Operation & Maintenance SOPs 13. Responsible for handling QMS activities during project phase as well during operations. Soft Skills: 14. Proficiency in MS Office 15. Knowledge in AutoCAD will be an added advantage Preferred candidate profile

Prepare trending of Events/Incident and ensure completeness of its closure. Identify the gaps and provide appropriate training to analytical scientist to strengthen compliance level. Thorough review of clinical batch release data, method validation protocol & report, clinical stability sample analysis, as per cGMP and regulatory requirement. Ensure review of daily verification/calibration of pH meter, balances and TOC. Ensure review of calibration record of all analytical instruments and update of calibration planner in timely manner. Thorough review of method development report and investigation study report Randomly review and cross verify all analytical instrument logbook entries and laboratory notebook for its completeness for compliance point of view. Randomly review of standard, column and chemical management logbooks. Ensure in-house compliance system. Randomly review of QMS activities (i.e. change control, incident, deviation). Maintain hygienic condition in laboratory. Follow GxP (GMP, GDP, GLP) for all processes. Ensuring proper use of Personal Protective Equipment. Thorough review of IQ/OQ and PQ of instrument/equipment. Ensure computer System Validation according to CSV SOP and identify gap in qualification document according to CSV SOP. Perform internal audit of AD and provide appropriate training to AD team. Accompany the internal audit and provide appropriate response to audit observations. Training on GDP/GLP/DI to the scientist on quarterly basis to ensure compliance. Tracking and monitoring of calibration planner and preventive maintenance planner. Responsibilities Qualifications M. Pharm/ M.Sc. Chemistry

We are hiring for multiple position in Microbiology Dept. Contact person Mr. Srinivasa M, those who are unable to attend the interview are requested to forward their resumes to email id: naveenkumarp@microlabs.in, jonesnaveenrajp@microlabs.in Candidates are requested to carry their copies of Resume, Mark Sheets, Experience Certificates, Latest salary certificate, pay slips of three months and one photographs. MICROBIOLOGY Dept: Position: Sr.Officer/ Executive / Sr. Executive ( Only for male candidates) Qualification: B.Sc/ M.Sc- Microbiology/ BioTech Experience: 2-8 years experience in Sterile Manufacturing facility. Job Profile: Microbiology Analytical Activities (MLT, BET, Stability), Environmental monitoring, QMS activities in sterile manufacturing facility.

Role & responsibilities Review of Analytical method validation, method transfer and method verification protocols & reports. Review of method development reports. Review of Stability & Holding Study analysis data. Review of equipment qualification /calibration/ validation reports (IQ, OQ, PQ) related to all analytical instruments. Should have knowledge on review of Specifications & Standard test procedures. Review of reference standard and impurity COAs and characterization data. Should have knowledge of GTI & Nitrosamines risk assessment. Responsible for issuance and archival of documents. Should have good knowledge of ICH guidelines, USP general chapters. Should have knowledge of QMS activity (Incidents, Change controls). Review of Empower and other analytical instruments audit trails. Responsible for maintaining GLP & GDP at the workplace. Excellent written and verbal communications skills. Preferred candidate profile