14 Qms Activities Jobs

As a Quality Assurance Specialist, your primary responsibility will be to handle Change Management, Deviations, Out of Trend, Out of Specification, and CAPA closure before the product release. This includes coordinating QMS activities in the Track Wise system and managing documents through the SAP system. It is essential to track and complete all QMS activities within the specified due date. You will be tasked with coordinating complaint investigations, managing Return Goods, and handling Recalls. Additionally, reviewing contract manufacturing and testing documents such as executed BPR and Analytical reports will be part of your duties. Your role will involve performing unplanned audits on the shop floor, monitoring the Manufacturing Process to identify root causes for product failures and cleaning incidents, and reviewing and closing Change control and related action items. Archiving of change control and other related documents will also fall under your purview. Preparation of Quality Assurance SOPs, reviewing plant SOPs, handling change control and deviations related to warehouse & SCM, and preparing and reviewing Risk Assessment reports for New Products & process change products are critical tasks that you will be responsible for. You will also be required to prepare risk assessments and declarations as per customer requirements and current guidelines. Reviewing Vendor Qualification documents, communicating with Vendors/Supply Chain Management, preparing Vendor audit schedules, implementing schedules as defined, maintaining SOP formats and Annexures, updating Approved Vendor lists periodically, and preparing and reviewing Annual Product Quality Reports and Product Quality metrics are key components of your role. Furthermore, you will review process validation protocols and reports, prepare and review cleaning validation protocols and reports, and handle any work assigned by your reporting Manager. In the absence of the position holder, operational responsibilities will be delegated to Direct reports or a designee.,

Date: 2 Aug 2025 Location: Bangalore, KA, IN, 560099 Custom Field 1: Essential Functions Job Description Job Title: GLP-Quality Assurance Personal Job Location: Syngene International Limited, Bengaluru About Syngene : Syngene ( www.syngeneintl.com ) is an innovation-led contract research, development and manufacturing organization offering integrated scientific services from early discovery to commercial supply. At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures and SOPs, in letter and spirit. Mandatory expectation for all roles as per Syngene safety guidelines Overall adherence to safe practices and procedures of oneself and the teams aligned Contributing to development of procedures, practices and systems that ensures safe operations and compliance to company&aposs integrity & quality standards Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times. Ensuring safety of self, teams and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements at all times in the workplace. Ensure all assigned mandatory trainings related to data integrity, health, and safety measures are completed on time by all members of the team including self Compliance to Syngene' s quality standards at all times Hold self and their teams accountable for the achievement of safety goals Govern and Review safety metrics from time to time Core Purpose Of The Role This is an exciting opportunity to play a role in the GLP Quality Assurance Unit at Syngene. The role offers valuable exposure to aligning laboratory practices with GLP guidelines, which is crucial for ensuring the integrity and reliability of non-clinical safety and clinical studies. Additionally, it provides a chance to work in a regulatory environment, ensuring that Syngene adheres to national and international standards set by organizations such as OECD, FDA, ICH, and ISO. Role Accountabilities To Ensure compliance to Organization for Economic Co-Operation and Development (OECD) principles of Good Laboratory Practices (GLP), and ICH, WHO-GCLP. Handling of inspections and audits. Handling of QMS-Change controls, deviations, and CAPA Review of SOPs and study plans. Performing/scheduling study, facility, and process-based inspections for analytical and bioanalytical domains. Perform audit of study raw data & study report. Preparation and /or review of SOPs and other documents related to QAU. Review of general documents/SOPs, Study Plans, and Study Reports. Review of computerized system documents concerning OECD 17,21 CFR Part 11. Syngene Values All employees will consistently demonstrate alignment with our core values. Excellence Integrity Professionalism Specific Requirements For This Role Experience Demonstrated Capability Education Experience: 06-09 Years Knowledge of GLP principles as per OECD, and familiarity with ICH, FDA, and EPA guidelines in a GLP environment. Handling of QMS activities, including change controls, deviations, and CAPA. Proficient in reviewing SOPs and study plans for regulatory compliance. Good Understanding of data integrity policies and standards. Skilled in conducting inspections of studies, facilities, and processes in analytical and bioanalytical domains. Ability to audit raw and electronic study data and reports for accuracy and compliance. Experienced in preparing and reviewing QAU documentation and SOPs. Competent in reviewing equipment and computerized system qualifications per OECD Principles 17 and 21 CFR Part 11. Prepare the data for quality meetings. Skills And Capabilities Expertise in handling multiple software applications and tools Capable of thinking scientifically to address complex problems and develop solutions Work as a team and have a collaborative mindset Good communication skills Education Master&aposs degree in Pharmacology, or any Chemistry, with a strong foundation and comprehensive expertise Equal Opportunity Employer It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status about public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities. Show more Show less

About Apotex Inc. Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 7,200 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 75 countries globally. Through vertical integration, the Apotex group is focused on the development and sale of generic, biosimilar and specialty products. For more information visit: www.apotex.com. Job Summary Responsible for allocation of work to the technicians in shifts and ensuring completion of activity. Ensuring /Performing PM activities of Process equipments within the specified limit and updation of work orders online. As per maintenance work request / corrective maintenance work orders , completion of the activity within the time line. To give training to new technicians for maintenance activities.Responsible for Preparation and review of SOPs and relevant Formats, QMS and other Engineering GMP activities and other activities as assigned. To maintain relevant log books as per cGMP standards. Installation, modification, repair, planning and executing upcoming projects, Qualification, online documentation, preparation of documents and review of documents as per SOP Job Responsibilities Execute all engineering operations as per established ARPL standards and procedures. Adhering to cGMP procedures as per the company policy. Compliance to Safety & Quality standards maintained within the company. Adherence to the departmental procedures. Complaince to the Online Documentation and Good Documentation Practices. Adherence to the Preventive Maintenenace schedule, AMC Schedule and ensuring the quality compliance. Execution of Preventive Maintenance of Process, Packing, Warehouse, Microbiology Equipments as per the approved schedule. Handling the Maintenance related activities within the process area and in service areas. Ensuring completion of Maintenance Work Request in co-ordination with user department. Work Request Printing , Confirmation for PM and Corrective Maintenance in SAP-PM Module. Carrying out the AMC of machines in coordination with vendor as per the schedule. Ensuring the execution of all scheduled Preventive Maintenance of equipments are performed within defined time limits as per the approved schedule. Monitor in co-ordination with the user departments for maintenance issues / problems and ensuring completion of maintenance requests / corrective maintenance work orders. Executing / Supervise with the help of contractors on daily basis for follow up and completion of maintenance activities. Ensuring and maintaining engineering inventory management / up keep of minimum stock availability for engineering spares. Execute / supervise / monitor with the help of external agencies for periodic calibration of various instruments & equipments. Prepare / Check and review planned preventive maintenance schedules, validation protocols and reports in line with the cGMP requirements. Providing all required maintenance support to ARPL as per the departments requirements and operates in full compliance with all regulatory requirements and according to established safety norms. As per requirement creating material management requisition in SAP for material procurement related to process engineering. Ensuring and maintaining safe work place at ARPL all time in coordination to EHS personnel. Plan/Execute / Coordinate / maintain Quality in upcoming engineering projects in line with the cGMP and organization requirements Regular checks on My Training Plan and ensuring the adherence to training requirement as applicable Demonstrate Behaviors that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion. Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies. All other relevant duties as assigned Job Requirements Education Bachelor Of Mechanical Engineering / Electrical/instrumentation Engineering Knowledge, Skills and Abilities Should have good knowledge in engineering activities and handling the GDP and GMP documents Should have good interpersonal, writing and communicational skills Should have good knowledge in Engineering change management. Should have sound Knowledge in SAP PM/ MM modules. Should have adequate knowledge and skills in QMS activities Should have Hands on experience in SAP, Excel, Ms project etc. Strives to drive projects related to engineering. Skills in Project and Plant Maintenance. Experience 4 years experience in plant maintance of OSD Production equipments At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported. Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation. Show more Show less

About Apotex Inc. Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 7,200 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 75 countries globally. Through vertical integration, the Apotex group is focused on the development and sale of generic, biosimilar and specialty products. For more information visit: www.apotex.com . Job Summary Responsible for allocation of work to the technicians in shifts and ensuring completion of activity. Ensuring /Performing PM activities of Process equipments within the specified limit and updation of work orders online. As per maintenance work request / corrective maintenance work orders , completion of the activity within the time line. To give training to new technicians for maintenance activities.Responsible for Preparation and review of SOPs and relevant Formats, QMS and other Engineering GMP activities and other activities as assigned. To maintain relevant log books as per cGMP standards. Installation, modification, repair, planning and executing upcoming projects, Qualification, online documentation, preparation of documents and review of documents as per SOP Job Responsibilities Execute all engineering operations as per established ARPL standards and procedures. Adhering to cGMP procedures as per the company policy. Compliance to Safety & Quality standards maintained within the company. Adherence to the departmental procedures. Complaince to the Online Documentation and Good Documentation Practices. Adherence to the Preventive Maintenenace schedule, AMC Schedule and ensuring the quality compliance. Execution of Preventive Maintenance of Process, Packing, Warehouse, Microbiology Equipments as per the approved schedule. Handling the Maintenance related activities within the process area and in service areas. Ensuring completion of Maintenance Work Request in co-ordination with user department. Work Request Printing , Confirmation for PM and Corrective Maintenance in SAP-PM Module. Carrying out the AMC of machines in coordination with vendor as per the schedule. Ensuring the execution of all scheduled Preventive Maintenance of equipments are performed within defined time limits as per the approved schedule. Monitor in co-ordination with the user departments for maintenance issues / problems and ensuring completion of maintenance requests / corrective maintenance work orders. Executing / Supervise with the help of contractors on daily basis for follow up and completion of maintenance activities. Ensuring and maintaining engineering inventory management / up keep of minimum stock availability for engineering spares. Execute / supervise / monitor with the help of external agencies for periodic calibration of various instruments & equipments. Prepare / Check and review planned preventive maintenance schedules, validation protocols and reports in line with the cGMP requirements. Providing all required maintenance support to ARPL as per the departments requirements and operates in full compliance with all regulatory requirements and according to established safety norms. As per requirement creating material management requisition in SAP for material procurement related to process engineering. Ensuring and maintaining safe work place at ARPL all time in coordination to EHS personnel. Plan/Execute / Coordinate / maintain Quality in upcoming engineering projects in line with the cGMP and organization requirements Regular checks on My Training Plan and ensuring the adherence to training requirement as applicable Demonstrate Behaviors that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion. Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies. All other relevant duties as assigned Job Requirements Education Bachelor Of Mechanical Engineering / Electrical/instrumentation Engineering Knowledge, Skills and Abilities Should have good knowledge in engineering activities and handling the GDP and GMP documents Should have good interpersonal, writing and communicational skills Should have good knowledge in Engineering change management. Should have sound Knowledge in SAP PM/ MM modules. Should have adequate knowledge and skills in QMS activities Should have Hands on experience in SAP, Excel, Ms project etc. Strives to drive projects related to engineering. Skills in Project and Plant Maintenance. Experience 4 years experience in plant maintance of OSD Production equipments At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported. Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation. Show more Show less

You will be responsible for managing all Quality Management System (QMS) activities related to production. It is crucial to ensure that batch charging and other manufacturing operations strictly adhere to the Batch Manufacturing Record (BMR) and Standard Operating Procedures (SOP), aligning with current Good Manufacturing Practices (GMP). Your duties will include maintaining manufacturing records online, collecting samples of intermediate materials, entering production-related data into the SAP system, and verifying the generation of PISCADA reports. Additionally, you will be tasked with overseeing finished goods transfer, monitoring stock levels of consumables, coordinating with various service departments, and ensuring preventive maintenance of equipment. Safety is a top priority, and you must follow safety procedures, attend training sessions, conduct staff training, and report any incidents promptly. As part of your role, you will manage the allocation of Isoflurane bulk to customers, participate in initiatives like AET and CSR, and perform senior duties in their absence. It is essential to prepare and execute operational protocols, SOPs, and maintain documentation accurately. Your attention to detail is crucial in handling tasks such as DocuSign and tracking related activities. Qualifications: - B.E / B.Tech in Chemical Engineering About The Team: Piramal Critical Care (PCC), a subsidiary of Piramal Pharma Limited (PPL), is a global player in hospital generics, specializing in Inhaled Anaesthetics. With a commitment to delivering critical care solutions worldwide, PCC aims for sustainable growth and stakeholder satisfaction. The team operates across the USA, Europe, and over 100 countries, offering a diverse product portfolio and maintaining high-quality manufacturing facilities. PCC values corporate social responsibility and collaborates with partner organizations to support communities and the environment. As part of the Piramal Group, PCC upholds ethical practices and inclusive growth, providing equal opportunities for all employees based on merit and performance.,

You are invited to attend a walk-in interview for Zydus Animal Health Unit in Ahmedabad on 03rd August 2025 at Hotel Woodlands, NH 8, Near Tejpal Motors, Balitha, Vapi, Gujarat 396191. The interview timings are from 9:00 AM to 04:00 PM. The job location is Pharmez Matoda, Ahmedabad. In the Manufacturing (OSD) Department, we are looking for candidates for the following roles: 1. Officer/Executive: - Qualification: B. Pharma/M. Pharma - Experience: 2 - 7 years - Responsibilities: - Planning manufacturing batches in coordination with PPMC - Monitoring line clearance, cleaning of equipment, and instruments - Performing qualification activities - Initiating QMS activities such as change control, deviation, CAPA, and investigation - Handling manpower and allocating daily activities 2. Plant Operator/Technical Assistant: - Qualification: ITI/Diploma - Experience: 3 - 8 years - Responsibilities: - Operating machines like Granulation (Glatt, GEA), Cadmach Roll Compactor, and Compression machines (Cadmach-26STN) - Performing line clearance, operation, and cleaning of equipment/instruments/auxiliary items In the Engineering Department, we have openings for the following positions: 1. Sr. Executive/Executive: - Qualification: BE/B.Tech - Experience: 3 - 8 years - Responsibilities: - Managing Utility Operations like HVAC, Chiller, Air Compressor, Cooling Towers, and Boiler Operations - Handling Process Equipment maintenance and Plant maintenance activities - Implementing QMS 2. Plant Operator/Technical Assistant: - Qualification: ITI/Diploma in Engineering - Experience: 2 - 8 years - Responsibilities: - Managing machinery breakdowns, executing preventive maintenance, and ensuring uninterrupted production processes - Handling water system operations and electrical maintenance - Performing civil work like painting, plumbing, and building maintenance If you have the required qualifications and experience for any of the mentioned roles, we look forward to meeting you at the walk-in interview to discuss your potential contribution to our team at Zydus Animal Health Unit in Ahmedabad.,

Date: 2 Jul 2025 Location: Bangalore, KA, IN, 560099 Custom Field 1: Essential Functions Job Description Job Title: QMS Project Reviewer Job Location: Syngene International Limited, Bengaluru About Syngene : Syngene (www.syngeneintl.com) is an innovation-led contract research, development and manufacturing organization offering integrated scientific services from early discovery to commercial supply. At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures and SOPs, in letter and spirit Mandatory expectation for all roles as per Syngene safety guidelines Overall adherence to safe practices and procedures of oneself and the teams aligned Contributing to development of procedures, practices and systems that ensures safe operations and compliance to companys integrity & quality standards Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times. Ensuring safety of self, teams and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements at all times in the workplace. Ensure all assigned mandatory trainings related to data integrity, health, and safety measures are completed on time by all members of the team including self Compliance to Syngene s quality standards at all times Core Purpose Of The Role This is an exciting opportunity to play a role in drug substance development and manufacturing of Syngene. The role will provide exposure to handling clients across the globe, interaction with cross-functional departments and activities involved from product introduction to discontinuation. It provides an opportunity to learn different aspects of product development to commercial manufacturing. Role Accountabilities Follow GMP, GDP, and GLP procedures as applicable, while performing the assigned task. Create/ revise/ review of procedures (like SOP, protocols, calibration schedule, and other related documents as applicable.). Review and approval of Master BMR and PDR and its compliance. Review of TTD related to Late phase and commercial. Responsible for issuance and control of BMRs, PDRs, SOPs, EOPs and ECCs.Verify the product details, batch no., quantity, label, purchase order, RM issue slip, CoA, weights, packing and dispatch record, packing area (not limited to) and provide clearance to dispatch activity. Assessment of SOP vs guidelines for any gaps and taking appropriate actions. Investigate, review of investigation with respect to OOS/OOT and involve in the identification of root cause and to propose the CAPA for identified root cause. Preparation and review of QMS Trends (Deviation, LIR, OOS, OOT, Change control & Complaints). Handling of returned products and product recall. Syngene Values All employees will consistently demonstrate alignment with our core values Excellence Integrity Professionalism Specific requirements for this role Experience Demonstrated Capability Education Experience 3 - 6 years into Project related QMS activities (Change control, Deviations, CAPA, OOS, LIRs) Must have handled clients Expertise in review of Master Batch Record, Batch Record and Analytical Documents Knowledge on Good Documentation and laboratory practices Good coordination among CFTs Skills And Capabilities Expertise in handling QMS Activities Good knowledge about project related activities Client handling experience Master Batch Record, Batch Record and Analytical Document Review skills Specification and Method of analysis review Good communication skills Education MSc. Chemistry Equal Opportunity Employer It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities. Show more Show less

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