275 Cgmp Jobs - Page 7

Key Responsibilities: In-Process (IP) Responsibilities: Perform line clearance and IP checks during manufacturing and packaging activities. Monitor critical process parameters during granulation, compression, coating, filling, and packing. Verify BMR/BPR entries and ensure Good Documentation Practices (GDP). Collect and test in-process samples as per approved specifications. Report and escalate any deviations, non-conformities, or abnormal observations. Finished Product (FP) Responsibilities: Sample and submit finished product batches for QC testing. Coordinate with the QC department for timely testing and release of finished goods. Ensure FP storage conditions and labeling are as per SOPs. Assist in reviewing batch records and supporting batch release activities. Coordinate with warehousing for approved and rejected batch segregation. Qualifications: B.Pharm / M.Pharm / B.Sc. / M.Sc. in Chemistry, Microbiology, or relevant field. 13 years of experience in QA or QC, preferably in formulations or oral solid dosage manufacturing. Key Skills: Good understanding of cGMP, GDP, and regulatory compliance (USFDA, WHO, MHRA, etc.). Knowledge of production processes and quality checkpoints. Strong documentation, observation, and communication skills. Familiarity with QMS tools like deviation, change control, and CAPA (optional but preferred). Ability to work in shifts and in a fast-paced environment.

Key Responsibilities: Prepare and execute validation protocols (IQ, OQ, PQ) for equipment, facilities, and utilities. Conduct cleaning validation and revalidation studies, including swab/rinse sampling and microbial testing coordination. Perform process validation (PV) activities for new and existing products. Coordinate with cross-functional teams (Production, QC, Engineering, R&D) for validation execution and troubleshooting. Review and update validation master plans (VMP), protocols, and reports as per regulatory requirements. Ensure calibration and qualification records are up to date and compliant. Maintain documentation in compliance with data integrity and ALCOA+ principles. Support audits and regulatory inspections by providing validation documentation and clarifications. Track and monitor validation schedules and ensure timely completion. Stay updated with latest regulatory trends, validation guidelines, and industry best practices (ICH Q8, Q9, Q10, Q12). Qualifications: B.Pharm / M.Pharm / B.Sc. / M.Sc. (Microbiology, Chemistry, Biotechnology) or related field. 25 years of relevant experience in validation within a pharmaceutical or healthcare manufacturing setup. Knowledge of cGMP, WHO, USFDA, EU, and other regulatory requirements. Key Skills: Sound knowledge of validation principles, risk assessment, and lifecycle approach. Proficiency in drafting validation protocols and technical documentation. Experience with computerized system validation (CSV) is an advantage. Good analytical, problem-solving, and organizational skills. Effective communication and ability to work in a team.

Spica Labs Pvt. Ltd. is hiring QC & QA male candidates with experience in HPLC, UV, IR, GMP, BMR review, SOPs, validation, deviations & regulatory knowledge. Send resumes to: spicalabspvtltd@gmail.com.

Job Overview Head of Engineering & Maintenance- will lead all engineering and maintenance operations for a large-scale API pharmaceutical plant. This role is responsible for ensuring the optimal performance, reliability, and compliance of plant equipment, systems, and facilities. The position requires extensive experience in API manufacturing, including expertise in CGMP, FDA regulations, and managing regulatory audits. Develop and execute maintenance strategies, drive continuous improvement, manage OPEX budgets, and lead a high-performing team to ensure safe, efficient, and compliant plant operations. Key Stakeholders: Internal Production , Supply Chain, Finance, Warehouse, operation excellence ,HR/QA, QC & Validation. Key Stakeholders: External Govt Departments, Regulatory Agencies, Suppliers, Vendors Reporting Structure Global Engineering Head & Project Head & Site Head Reportees :All Plant Engineering & Maintenance team Experience 20 years in a Pharmaceutical API Facility Competencies Must have extensive experience in API pharmaceutical manufacturing, with a deep understanding of CGMP, FDA regulations, and other regulatory audit requirements. Expertise in ensuring compliance with these standards while optimizing maintenance strategies and driving operational improvements is essential. The role requires a strong track record in managing audits, addressing non-conformities, and maintaining a high standard of product quality and safety. Responsibilities Leadership & Strategy: Lead, manage, and develop the Engineering & Maintenance team to drive plant operational excellence. Develop and execute a comprehensive maintenance strategy, ensuring a proactive approach to maintenance, asset integrity, and equipment reliability. Drive continuous improvement initiatives to optimize plant performance and reduce unplanned downtime. Manage operating expenditure (OPEX) budgets for Engineering & Maintenance activities. Maintenance & Reliability Management: Ensure all critical equipment and systems are maintained in optimal condition to meet production goals and regulatory requirements. Oversee the implementation of preventive and predictive maintenance programs, improving plant uptime and reliability. Develop and implement a comprehensive asset management strategy, including lifecycle management for critical equipment. Regulatory Compliance & Safety: Ensure all maintenance activities are compliant with GMP, FDA, and other relevant pharmaceutical regulations. Promote a culture of safety and adherence to the highest environmental, health, and safety (EHS) standards. Lead the investigation and resolution of any maintenance-related incidents, ensuring timely and effective corrective actions. Team Development & Talent Management: Mentor, train, and develop Engineering & Maintenance personnel, ensuring their skills and capabilities meet the evolving needs of the plant. Foster a culture of collaboration, teamwork, and continuous learning within the team. Lead recruitment efforts to fill skill gaps within the department and drive talent development initiatives. Collaboration & Cross-Functional Coordination: Work closely with Production, Quality, and Supply Chain departments to ensure alignment between maintenance schedules and production plans. Collaborate with the plant leadership team to identify opportunities for process optimization, cost reductions, and productivity improvements. Technology & Innovation: Identify and implement new technologies that improve equipment performance, reduce maintenance costs, and enhance production efficiency. Stay current with industry best practices, technology advancements, and emerging trends in pharmaceutical manufacturing and maintenance Qualifications Bachelors degree in Engineering (Mechanical, Electrical, or related field)

Role & responsibilities The position is responsible for Moisture and Thiomersal estimation and ensuring GMP practices Physical observation of vaccines and diluents Formulation Verification Record maintenance Maintenance of Live and Inactivated FG samples and register Maintenance of Pullet ND samples at R&D in coordination with production Moisture estimation of Live vaccines, stability & record keeping and R&D testing To Fill records & BTR Regarding Moisture Determination RM - pH, viscosity, density, specific gravity, refractive index, LOD, water Egg sampling and record maintenance Maintenance of retain samples of RM Preferred candidate profile Should have technical knowledge in GMP, GLP, ISO, IS, IP, BP guidelines, MS office Good in communication, inter-personal relationships Job Location: Kadi,Gujarat ( Bus facility available from Ahmedbad,Kalol & Kadi)

Role & responsibilities Ensure the compliance of cGMP & EHS. Follow the cGMP requirement with appropriate housekeeping and documentation in manufacturing area. Co-ordination with other department for safe, successful and timely batch execution. Achieving plant production target w.r.t quality and yield. Active involvement in facing quality audits by vendor audit & regulatory audits. Lead from front to ensure safe behaviour / GMP culture on the shop floor. Comply with online documentation with complete data integrity. Undergo safety, quality and operational training & comply with requirement. Maintain housekeeping standard to ensure a clean and safe workplace. Follow the SOP practices. Preparation to comply statutory audit, customer audit and regulatory audit. Batch charging and process work out as per written instruction. Shift handover / instruction/ information communication. Operation & cleaning of Equipments. Suggests changes in working conditions and use of equipment to increase efficiency of equipment. Initiates or suggests plans to motivate workers to achieve work goals. Maintaining cleanliness and hygienic practices in the plant premises.

Key Responsibilities: Perform analytical testing and analysis of raw materials, intermediates, and finished pharmaceutical products. Conduct instrumental and wet chemistry techniques, including HPLC, GC, UV-Vis, FTIR, and titrations. Develop and validate analytical methods for new and existing pharmaceutical formulations. Conduct stability studies and ensure proper documentation of results. Maintain and calibrate laboratory instruments and equipment. Prepare and review standard operating procedures (SOPs) for analytical testing and instrument operation. Ensure compliance with cGMP (current Good Manufacturing Practices), ICH guidelines, and other relevant regulatory standards. Support analytical troubleshooting and provide solutions for any issues that arise during testing. Review and interpret data, providing detailed reports and documentation for regulatory submissions. Collaborate with cross-functional teams, including R&D, production, and regulatory affairs. Conduct investigations and root cause analysis in case of product quality deviations. Maintain accurate records of all laboratory activities and ensure data integrity. Stay updated with new analytical techniques, instruments, and industry trends.

Job Title: CSV Analyst (Computer system validation) Location: Hyderabad Exp level: 7-10 Years Work mode : Work from Office Shift Timings: UK Shift Primary Skill: CSV (Computer system validation) Secondary Skill: Pharma IT Quality

Location- Novo Nordisk Global Business Services (GBS), Ahmedabad, India Department- GCM Operations Drug Product Are you ready to take charge and make a difference in the pharmaceutical industryIf you’re a dynamic person with a passion for quality and operational efficiency, you might be our new Operations Manager. The position is based in Ahmedabad in India and will report directly to GCM organization based in Denmark. Apply today and get life changing career! Apply now! The position As an Operations Manager, you will be responsible for ensuring Novo Nordisk’s interests with regards to short to midterm capacity, compliance, quality, manufacturing readiness and activities at the CMO. You will have a substantial impact on the business with the CMO with regards to strategy input, prioritization and following up on agreed actions and improvements. Your other responsibilities will be to: Responsible for short to midterm capacity, compliance, quality, manufacturing readiness and activities at selected CMOs ensuring timely delivery of products to downstream customers with a strong focus on production performance and quality. Developing and following up on joint KPI’s and creating a robust working relation with the CMOs. Identify and implement changes and process improvements at CMOs in order to create a strong and solid foundation for future growth in this area. Develop new work standards and setups for collaboration between GCM DP and relevant CMO’s delivering aseptic manufacturing activities. Participate in project work to the extent needed to ensure new projects/CMOs enter operations in a satisfactory manner. Approximately 3–5 weeks of travel per year is expected as part of this role. Qualifications To be successful in this role, you should have: Master’s or Bachelor’s degree in Engineering, Pharmacy, or a Supply Chain-related field, with excellent written and verbal communication skills and a strong command of English 10 years of experience within pharmaceutical manufacturing / packaging and cGMP and 5 years of experience with outsourcing or managing global CMOs. Experience in Production, Manufacturing Operations, Project management or Supply Chain management. Experienced in handling Changes, Deviations, and Customer Complaints, with strong knowledge of regulatory guidelines in the pharmaceutical industry, excellent relationship management skills, and a solid understanding of GxP principles. Team player demonstrating collaborative behavior, effective communicator providing clear and timely information to stakeholders, with a technical, analytical, and structured approach to problem-solving. About the Department Global Contract Manufacturing Drug Products (GCM DP) oversees all aspects of commercial external production, including filling, assembly and packaging. We prioritize diversity, encourage empowerment, and pride ourselves with a varied workforce, comprising a range of professional profiles such as project managers, supply chain professionals, specialists and operation managers.

Role & responsibilities Routine activities of Production department Batch processing CGMP GDP SOP Preferred candidate profile Relevant experience from Pharmaceutical and Chemical industry. Must have cGMP experience.

Role & responsibilities Job Description: 1. Preparing and implementing of standard operating Procedures, Batch records, Protocols, cleaning procedures and relevant log sheets. 2. Maintaining documents as per regulatory and cGMP norms. 3. Handling of QMS activities, Change controls, Deviations, Incidents and risk assessments. 4. Responsible for ensuring the department employees for training as per training plan schedule in the TRIMS. 5. Responsible to attend all training programs, SOPs and cGMP trainings relevant to area and equipments. 6. Responsible for monitoring of periodic review of SOP’s related to FP Departments and ensuring the completion with in due date. 7. Performing DQ, IQ, OQ, and PQ for the equipment’s. 8. Writing of relevant Batch documents and log books. 9. Execution of production plan for formulation and filling. 10. Achieving planned FP targets with strict adherence to cGMP. 11. Execution of planned activities of Aseptic Processing Areas like media fills simulation trials, Formulation and filling activities. 12. Execution of preventive maintenance plan for equipment’s in coordination with Engineering and QA departments. 13. Performing day to day activities as per requirements. 14. Reporting all the activities, deviations and issues to Reporting officer. Preferred candidate profile ITI/ DIPLOMA/ B. TECH/ Pharmacy With Relevant experience

Strong knowledge of cGMP regulations, quality management systems, and industry best practices. Exposure to international regulatory inspections like USFDA, EDQM. Exposure to international regulatory inspections like USFDA, EDQM Required Candidate profile Bachelor’s degree in pharmacy or master’s degree in chemistry from a recognized university.6-9 years of experience in quality assurance roles within the pharmaceutical or API manufacturing industry.

Experience in pharma regulatory & QMS function, primarily in RLD / comparator sourcing, clinical trial supply chain management, and clinical packaging for USA and EU markets. The role includes supporting the end QMS function and regulatory affairs. Health insurance Provident fund Annual bonus

Role & responsibilities JD- Designation: Deputy manager Department: QA Role: vendor qualification Experience:6-10 years of relevant experience. 1)Preparation and Review of procedures related to Vendor management as per regulatory requirements. 2. Review of QMS elements like Change management (Change control), Deviation, CAPA, related to external testing laboratories, service providers. 4. Management of vendor qualification (Related to Contract services/ contract Labs /CMO) documentation i.e. initiation of vendor assessment, tracking of their audit and periodic monitoring. 5. Responsible for vendor Audit Schedule, Execution of site audit for Contract Testing Laboratories, Contract Service Providers. 6. Preparation of Vendor audit reports, reviewing Audit CAPA reports, regular Follow-up to vendor for closure of Audit Observations. 7. Updating of Approved vendor list. 8. Handling of Quality Agreements/CDA with Vendors (Contract Testing Laboratories, Contract Service Providers) 10. Preparation of annual periodic verification of Vendors. Preferred candidate profile

Implement Amgen Quality Management System Identify Continuous Improvement opportunity for Quality Management System Develop Quality Procedures align with Amgen Quality Management System, cGMP requirements, GDP requirements and local regulations Oversight operations of local distributors and stockist to ensure local distributors operations are in compliance with cGMP requirements, GDP requirements, Amgen Quality Management System and Local regulations Act as Quality-related interface with internal and external customers (i.e. : Change control, Non Conformance, Product Complaint, Product Recall, Audit/ Inspection) Support local testing Support BD project and product launches Liaise with internal and external partners to manage day to day operations associated with distribution operations Monitor and ensure on time completion of NC, CAPA, Audit observation, Product complaint and other quality events Develop and Maintain the Quality Agreements with local distributors and partners Develop reports and provide the necessary communications throughout the organizations Develop or review or approve GMP and GDP documents Provide training to distributors and stockiest including distributors/stockist on-boarding training Actively participate on GMP intelligence to review local regulations, standards and guidance related to Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), product testing and Pharmacopoeia requirementsin India. Collaborate with Risk Management and Product Security on handling of counterfeit, product tempering, product theft and product diversion Interact with local regulators as needed. Keep the Senior Manager International Quality - JAPAC informed of the progress of projects and goals and advise on the potential areas of risk/ concern and new developments that may impact the company Support Named Patient Program Supplier Management:Performqualityoversight and audit of key suppliers to Amgen and its subsidiary companies. These suppliers can include API and starting material manufacturers as well as raw materials, devices and finished products suppliers, contract facilities, local laboratories, importers, distributors, logistics service providers, warehouse, etc. Apply advanced knowledge of Indian and global market regulations to assess supply security risks. Work on an active risk management tool etc. to appropriately deploy Quality Systems on oversight of Amgen suppliers; including selection and approval, due diligence assessment, intelligence monitoring, on-site visit/audit and (if needed) Person in Plant placement, etc.. Support in identifying, assessing and addressing supplier s GMP/GDP risks in collaboration with Amgen sites. Execute necessary tasks and projects as assigned by management in timely manner; to attain assigned goals. Provide support for regulatory inspections of key facilities as needed. Qualifications Pharmacist Registration in India. Hold a valid practicing certificate as Pharmacist in India. In-depth knowledge and experience of Good Manufacturing Practice (GMP) & Good Distribution Practice (GDP). Experience with Quality Management Systems including but not limited to change control, deviation, validation, complaints, disposition and audits/inspections. Experience with Commercial Quality Operations and third-party management. Experience with distribution models and/or establishment of new entity procedures a plus

Review DCS alarms. Ensure that batch charging and other manufacturing operations are strictly in accordance with the BMR/SOP and align with current GMP practices. Maintain manufacturing records online, ensuring compliance with data integrity practices. Collect samples of intermediate/in-process materials and send them to the IPQC/QC lab. Enter and verify production-related inputs in the SAP system. Review and ensure the generation of PISCADA reports. Transfer finished goods using the "Finished Goods Transfer Note." Monitor and ensure minimum stock levels of consumables, logbooks, and status labels. Ensure preventive maintenance of all equipment according to the schedule. Coordinate with service departments (QA, QC, Stores, E&M) for production-related activities. In case of any major abnormalities in the production area or activities, stop the activity immediately and inform superiors/production managers. Maintain housekeeping standards in the plant and ensure equipment cleanliness. Follow safety instructions/procedures and ensure the use of safety gear during work. Attend GMP and safety training sessions and implement the outcomes in the workplace. Conduct training for staff as a trainer. Be aware of the location and operation of firefighting equipment. Report any incidents or near misses in the MySafe portal. Rectify all safety and GMP-related observations. Do not leave the work area unattended or depart without prior permission from the manager. Manage the allocation of Isoflurane bulk to various customers. Participate in initiatives such as AET and CSR. Perform the duties of a senior in their absence or as authorized by a senior. Prepare and execute operational and performance qualification protocols. Prepare SOPs, BMRs, protocols, records, etc. Handle DocuSign and track related activities. Manage all QMS activities related to production.

To handle DCS as operator. Ensure batch charging & other manufacturing operations should be strictly as per BMR/SOP & in line with current GMP practices. To maintain manufacturing records online & should comply data integrity practices. To take out sample of intermediate/in-process material and send to IPQC/QC lab. To ensure the production related inputs in SAP system. To be check and ensure the PISCADA reports generation & review of DCS alarms. Transfer finished goods through Finished Goods Transfer Note. To Check and ensure minimum stock of consumables, Logbooks & status labels. Ensuring preventive maintenance of all equipment as per schedule. Co-ordinate with service departments (QA, QC, stores, E & M) for various production related activities. If any abnormality found in production area / activities, authorized to stop activity immediately & inform to superiors/production Manager. Responsible to maintain housekeeping in plant & take care the cleanliness of equipment. Follow safety instructions/procedures & ensure use of safety outfit while on works. To attend GMP & safety trainings & implement the trainings outcome at work place. Should be aware of the location of firefighting equipment and should know the operation. He should not leave the work spot unattended and go away without prior permission from shift-in-charge/Manager Responsible for allotment of work to operators & casuals. To involve in other initiatives such as AET & CSR

Lead research and development of APIs, excipients, and formulations. Optimize existing formulations and explore new product ideas. Conduct laboratory research, testing, and documentation. Collaborate with QC, production, and regulatory teams. Required Candidate profile Min 10 years of R&D experience in the pharmaceutical sector. Strong knowledge of formulation science, GMP, and regulatory norms. Skilled in analytical techniques, lab procedures, and instrumentation.

Roles and Responsibilities Prepare and review batch manufacturing records (BMR) and batch processing documents to ensure compliance with regulatory requirements. Monitor production processes to identify areas for improvement and implement changes to optimize efficiency and productivity. Collaborate with cross-functional teams to resolve issues related to product quality, process optimization, and equipment maintenance. Ensure adherence to cGMP guidelines throughout the production cycle.

Responsible to monitor operations in granulation, blending area, compression, coating and tablet inspection area. Responsible to manufacture and ensure quality of the product at respective processing area. Responsible to follow all regulatory/cGMP/Statutory/Company policies are followed in manufacturing area. Responsible for online documentation with real time data. Responsible to participate in equipment qualification and process validation activities Preferred skills : Granulation, Compression, coating and packing of & Exposure in OSDs

Mode of Work : Hybrid Location : Pune, Bangalore, Hyderabad, Pune, Noida, Gurgaon, Chennai, Kolkata, Skill Set : LIMS, GMP, cGMP, Starlims, Labware Lims, Labvantage. The opportunity Were looking for Senior with expertise in LIMS Implementations & Configurations for Life Sciences industries to join our Regulatory Compliance team. This is a fantastic opportunity to be part of a leading firm whilst being instrumental in the growth of emerging service offering. Your key responsibilities Work closely with business stakeholders, laboratory personnel, and IT teams to gather and document LIMS requirements. Gather and analyse business requirements related to LIMS functionality and enhancements. Analyse laboratory workflows and processes to recommend and implement LIMS solutions. Translate business needs into functional specifications and system configurations. Configure, test, and validate LIMS functionalities to meet business needs. Conduct impact analysis and risk assessments for LIMS changes and enhancements. Serve as a liaison between business users and technical teams to ensure effective communication and system alignment. Participate in business process mapping and workflow optimization to enhance LIMS utilization. Provide input on LIMS enhancements and new feature development to improve system performance. Assist in troubleshooting, identifying, and resolving LIMS-related issues. Conduct user training sessions and provide end-user support. Work with laboratory teams to ensure LIMS supports laboratory practices, procedures, and workflows effectively. Identify opportunities for automation and process improvement within laboratory operations using LIMS. Master Data Design Configuration Analyse the Technical documents such as SOP/STP/Monograms/Pharmacopeial references and convert them into LIMS compatible data sets. Configure master data elements such as test methods, sample types, specifications, workflows, and stability studies within LIMS. Maintain data integrity, consistency, and version control across the system. Implement changes and updates to LIMS master data in alignment with business and regulatory needs. Collaborate with cross-functional teams to ensure accurate data migration and system integration. Troubleshoot and resolve issues related to master data configuration and system functionality. Work on optimizing data structures and database management within LIMS. Configurations & Customizations Develop, customize, and implement LIMS applications to meet laboratory and business requirements. Configure, extend, and support LabWare LIMS, LabVantage LIMS, and other LIMS platforms. Integrate LIMS with other enterprise systems such as ERP, ELN, CDS, MES, and laboratory instrumentation software. Design and optimize databases for efficient storage and retrieval of laboratory data. Develop and maintain system interfaces, workflows, and automation scripts to streamline laboratory processes. Provide technical support, troubleshooting, and bug fixes for LIMS applications, ensuring minimal downtime. Collaborate with laboratory personnel, IT teams, and stakeholders to enhance system functionality and usability. Create and maintain system documentation, including user guides, SOPs, validation protocols, and technical specifications. Ensure compliance with industry standards such as CGxP, PICS, FDA 21 CFR Part 11, EU GMP Annex 11 etc. Stay up to date with new LIMS technologies, trends, and best practices. Ensure system security, access control, and compliance with IT policies. Provide ongoing support and maintenance for LIMS applications. Engage in change management processes and drive adoption of new system functionalities. Work with vendors and third-party providers to Configure, implement upgrades and enhancements. Demonstrate teamwork by working with cross functional teams across service lines in completing the deliverables within the timelines Maintain a strong client focus by effectively serving client needs and developing productive working relationships with client personnel. Stay abreast of current business and economic developments and new pronouncements/standards relevant to the client's business. Review status updates and prepare management presentations. Actively contribute to improving operational efficiency on projects & internal initiatives. Demonstrate a detailed knowledge of market trends, competitor activities, products and service lines. Contribute to performance feedback for staff Foster teamwork and a positive learning culture Understand and follow workplace policies and procedures Training and mentoring of project resources Cross skill and cross train the team members as per the business requirements Skills and attributes for success Strong understanding of laboratory workflows, sample lifecycle management, and data integrity principles. Familiarity with analytical techniques, laboratory instrumentation, and regulatory standards. Exposure to Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), and ISO 17025 compliance. Experience in working with scientific and analytical teams to align LIMS functionality with laboratory operations. Understanding of quality control, stability studies, environmental monitoring, and batch release processes within laboratories. Proficiency in LIMS software (e.g., LabWare, LabVantage, STARLIMS, SampleManager, or similar platforms). Knowledge of system integration with ERP, MES, or other enterprise applications. Previous experience as a Business Analyst or System Administrator or Master Data Manager working with LIMS. Hands-on experience in master data configuration within LIMS platforms. Experience in system validation, testing, and documentation. Exposure to Enterprise IT applications like ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, etc. in Pharmaceutical organization Understanding of relational databases and SQL queries. Experience with scripting or automation tools for LIMS is a plus. Understanding of API integrations, web services, and middleware solutions for LIMS. Ability to troubleshoot system and data issues efficiently. Strong problem-solving and analytical skills. Excellent communication and stakeholder management abilities. Ability to work independently and as part of a cross-functional team. Strong attention to detail and commitment to data integrity. Adaptability to dynamic business and regulatory environments. Demonstrated track record in project management, governance, and reporting Exposure to Data Integrity requirements and other applicable regulations Knowledge of Incident Management, Change Management. Prior experience of supporting Audits / Inspections To qualify for the role, you must have B.E/B.Tech (Comp. Science/ Life Sciences/Chemistry/Information Technology or a related field)/Postgraduate in Science (Preferably in Chemistry/Biochemistry) with 4-8 years of experience with Big 4 or Multi-National Regulatory Compliance companies or Leading Life sciences / Pharmaceutical Industries. Good interpersonal skills; Good written, oral and presentation skills. Interested Candidates can send their Cv's to frichardson@allegisglobalsolutions.com. Regards, Franklin.A

Job Objective: Plan, allocate and review testing for the release of all RM, processed material, finished products to achieve the committed lead time for Production and for achieving targeted OTDIF Maintain microbiological laboratory GLP compliant as per Schedule L of Drug and cosmetic act. Ensure implementation and sustain of safe environment in microbiology laboratory. SOP review & availability of current version Roles and Responsibilities: Daily review of testing of FP, RM, Water, Air, In-process & Swab as per given procedure and frequency. Daily work allocation to microbiologists. Daily review of records and logbooks maintained in microbiology laboratory. Daily communication to operation and QA for any OOS or OOT related to microbiology testing. Investigation and root cause analysis in case of microbiological failure (OOS/OOT) and implementation and sustenance of CAPA CAPA checklist audit as per define checklist and presenting data to higher management during global micro meeting. Review of microbiological trends for air and water as per define procedure and frequency. Surveillance of shop floor for GMP adherence. SAP entry for finished product in absence of microbiologists Maintaining microbiological laboratory as per laid down procedure. Review of Q & V documents related to microbiological risk involved. Review of validation activities in microbiology laboratory. Composite sample preparation and insurance in absence of microbiologist. Microbiology awareness training to shop floor people. Laundry audit / Monitoring of Housekeeping activities & Self inspection of various departments GLP and documentation, laboratory facility maintenance Microbiological testing of FP, RM, Water & Air in absence of other microbiologists

We are seeking an experienced and dedicated EHS Manager to lead our Environmental, Health, and Safety (EHS) initiatives at our Bangalore plant. This position is a people manager role, responsible for ensuring compliance with CGMP standards and the safe handling of chemical products. The EHS Manager will play a crucial role in fostering a culture of safety and sustainability within the organization. Leadership and Management: Lead and manage the EHS team, providing guidance, support, and development opportunities. Foster a culture of safety and environmental awareness among all employees. Compliance and Standards: Ensure Statutory compliance with local/national body , like Factory & Boiler departments, PCB, CPCB, Labor compliances , Environmental clearances and international EHS regulations and GMP standards, Proper Knowledge of Process safety. Develop, implement, and maintain EHS policies and procedures in alignment with corporate standards. Risk Assessment and Mitigation: Conduct regular risk assessments and audits to identify potential hazards and implement corrective actions. Monitor and analyze EHS performance metrics, reporting findings to senior management. Training and Development: Develop and deliver EHS training programs for employees at all levels. Promote continuous improvement in EHS practices through education and awareness initiatives. Incident Management: Lead investigations of EHS incidents, ensuring thorough analysis and implementation of preventive measures. Maintain records of incidents and ensure timely reporting to regulatory authorities. Sustainability Initiatives: Drive sustainability initiatives aimed at reducing waste and promoting resource conservation. Collaborate with cross-functional teams to integrate EHS considerations into operational practices. Who You Are: Bachelors degree in Environmental Science, Occupational Health and Safety, Chemical Engineering, or related field. Minimum of 10 years of experience in EHS management preferably in chemical Manufacturing Environment, certificate/Diploma in EHS recognized by state Government /Central Government. Strong knowledge of CGMP standards and chemical safety regulations, Hands on Experience in HAZOP study & Knowledge of PCB regulation i.e ETP/STP etc . Proven leadership skills with experience in managing teams. Excellent communication and interpersonal skills. Ability to analyze complex EHS data and develop actionable strategies.

Sodexo Food Solutions India Pvt. Ltd.ces is looking for MIS Admin Assistant to join our dynamic team and embark on a rewarding career journey Oversee the design, implementation, and maintenance of the information systems, including hardware, software, and networking infrastructure Manage the database systems, including data backup and recovery, data security, and data integrity Develop and maintain procedures for managing the information systems and technology infrastructure, including disaster recovery plans, security policies, and user access controls Analyze the business processes and identify opportunities for improvement through the use of information systems and technology Collaborate with cross-functional teams, including IT, finance, and business operations, to integrate information systems and technology with other systems and processes Monitor system performance and provide technical support to end-users to ensure the smooth operation of information systems and technology Strong analytical and problem-solving skills Excellent communication and collaboration skills

Hi, Greetings from Avani Consulting!!! Walk in Invitation: We have job opportunity with API Manufacturing Plant for Associate /Sr. Associate Production Profile for Mysuru Loaction. Interview Location BANGALORE We are having face to face interview on 21st June Saturday in Bangalore.- Single Round Face to face Company : A leading Pharma API Unit - in Mysore Position - Production Department Associate /Sr. Associate Work Experience Min 5 yrs in API in current Salary 20% to 25 % hike on current CTC. Note: No Charges If interested drop your CV to Shweta Gupta [ 7015954549|| shweta@avaniconsulting.com ] Thanks & Regards Shweta Gupta