291 Cgmp Jobs - Page 11

This senior leader will be responsible for strategic planning, operational excellence, compliance, and P&L accountability, reporting directly to the VP/Head of Operations. end-to-end product development, manufacturing, and quality assurance.

Business Unit / Function Department - Quality Control Location Bharuch; SEZ;;; Reports to Lab In charge-QC Summary of Job (Purpose/ objective of the job Department Organogram to be enclosed) candidate is required having complete experience in API/Bulk/ Intermediates industries as per global regulatory requirements and responsible for implementation and compliances of ICH-Q7A, cGMP, WHO-GMP, ISO9001, FSSC, HACCP / global QMS requirements at SEZ site. Key Responsibilities (Performance Indicators) Knowledge about IMS system (ISO 9001:2015, ISO 14001:2015 OHSAS 18001:2007, and cGMP, USFDA, FSSC - 22000, NABL . Analytical skill for QC instrument, i.e. GLC, HPLC, UV-Visible, FTIR, ICP, K/F, Melting point etc. Regularize the QC activities as per cGMP requirements. RM, PKG, In-process and FG sampling and Analysis. Co-ordination with QC staff, R and D, Commercial and production for quality and dispatch related activities for on time dispatches. Day to day monitoring and execution online all IPQC and FG analysis activities. Resolve the trouble shooting related to QC activities. Knowledge about 21 CFR Part 211, 111 with data integrity (Part-11) Awareness about responsible care (Environment, Health, Safety and Security) No. of Reportees Qualification and Experience M.Sc. (Chemistry) with 2 - 6 yrs. Key Competencies (Technical, Functional and Behavioral) Handling, Calibration and Hand-on experience of all QC instruments. Compliance of 21 CFR Part-11. Troubleshooting related to QC analytical instrument

Role & responsibilities Maintain site Annual validation Plan & track activities as per Validation Plan. Tracking & follow-up on Validation & Change Control records at site. Coordinate for eQMS records (Investigation, CAPA, effectiveness checks) closure at site. Monthly trending of Non-Conformance records at site. Data update for Daily & Monthly Quality meetings. Govern Global SOPs compliance at site. Manage periodic review of documents (SOPs, attachments, forms etc) at site. Vendor complaints: Handle vendor complaints at site for getting actions closed at site & with suppliers for on time closure. Training: Ensuring completion of site trainings as per training calendar at site. Work with Site "Education & Training Lead" to improve site training program (e-Learning). Key competencies Skill Required/ Tools/ Software: The individual is responsible to work in compliant with Good Documentation Practice (GDP) and current Good Manufacturing Practice (cGMP). Interpersonal Skill: The individual must have good communication skill with team, team-work capabilities, patience to work under pressure. Digital Skills: Effectively use MS tools, i.e., Word, Excel, PowerPoint, in day-to-day operations. If required, need to operate company software

Role & responsibilities The individual should be documenting Annual Product Quality Review (APQR): Collection of process and quality data for all products. The individual is capable for management of Retain Samples: Storage, maintain, visual inspection & destruction of Retain samples of all FG samples. Management of central document room/Documents: Issuance, Retrieval, Destruction & Control of all the GMP documents (eg: facility documents, Batch records, Protocols, Reports, etc.) Key competencies Skill Required/ Tools/ Software: The individual is responsible to work in compliant with Good Documentation Practice (GDP) and current Good Manufacturing Practice (cGMP). Interpersonal Skill: The individual must have good communication skill with team, team-work capabilities, patience to work under pressure. Digital Skills: Effectively use MS tools, i.e., Word, Excel, PowerPoint, in day-to-day operations. If required, need to operate company software.

Key Roles & Responsibilities : The individual is responsible to work in compliant with Good Documentation Practice (GDP) and current Good Manufacturing Practice (cGMP). Interpersonal Skill: The individual must have good communication skill with team, team-work capabilities, patience to work under pressure. Digital Skills: Effectively use MS tools, i.e., Word, Excel, PowerPoint, in day-to-day operations. If required, need to operate company software. Maintain site Annual validation Plan & track activities as per Validation Plan. Tracking & follow-up on Validation & Change Control records at site. Coordinate for eQMS records (Investigation, CAPA, effectiveness checks) closure at site. Monthly trending of Non-Conformance records at site. Data update for Daily & Monthly Quality meetings. Govern P&G Global SOPs compliance at site. Manage periodic review of documents (SOPs, attachments, forms etc) at site.

A. Job Objective Monitor and review In Process quality control checks to meet the required quality compliance as per specifications. Strategic and planning Functional Core:- Review and provide decision based on the IQC sheet Online feedback to production for correction Daily plant round for ensuring compliance of SOPs, GDP, GMP guidelines etc. on the shop floor Refer ZMIC for special instruction during color change/ product change and guide the IQC operator for the same. Review the implementation of the same. Monitoring CAPA during shifts. Investigation of internal stranger/failure to identify the Root cause analysis and take corrective/preventive action for the same. Track instance of repeat failure from operators and take measures/set processes to avoid re-occurrence of the same and to ensure FTR. Line clearance of camera inspections, HCM, ATS, printing machines and Final Inspection System Ensuring document verification generated during shift on daily basis against defined standards Internal process Preparation of various reports Maintenance and verification of gauges to ensure proper calibration of these equipments on a regular basis in each shift Ensure verification of shade against master and Macbeth report Verification of daily profiles and online graphs Periodically conduct process, product and systems Audit. To provide data for annual product quality review & Participate in APQR and finalise the recommender's People development Ensure proper manning and shift handling, shift activities. Effective training to the operators with evaluation for compliance. Effective manning to utilization of available sources.

To follow safety rules in the premises according to the company norms. Responsible for Dispensing, checking and receiving of PPM from warehouse on need basis. Responsible for operation Maintenance and cleaning of External washing and Vial washing & Depyrogenation tunnel areas. Operation and cleaning of glove integrity and filter integrity testers. Responsible to perform the in process checks during operation. Responsible for Decartoning activity. Responsible for monthly frequency activity. Responsible for line clearance before start of the Activity. Preparation and periodic revision of SOPs related to respective area. Monitoring of DP, RH and temperature area in their respective area. To maintain the BMRs and other log books in respective area as per cGMP and SOP. Responsible for timely completion of calibrations and validations in coordination with Eng. and QA related to respective areas. Responsible for the Operation and cleaning of Automatic visual inspection. Responsible to perform visual inspection of the products /media filled vials as per the sop. Operation and cleaning lux mater, visual inspection table. Operation and cleaning of glove integrity and filter integrity testers Preparation, filtration and issuance of disinfectant and deactivation solutions to all the sections in the production area. Responsible for cleaning and storage of all the filling machine accessories and change parts Operation and cleaning of table mounted LAF and Ceiling mounted LAF Operation and cleaning of steam sterilizer and HPHV steam sterilizer. Preparation of loads meant for Autoclaving like garments, disinfectant, filling, filtration, rubber stopper and seals for sterilization as per the validated load pattern. Responsible for ensuring garments washing, drying and folding activities Timely completion of SOPs Training and On the job trainings related to respective area. Responsible for Maintenance of cleaning in in External washing and vial washing area & Depyrogenation tunnel areas and f Component preparation and sterilization area. Cleaning and sanitization of drain points in External washing and Vial washing & Depyrogenation tunnel areas and f Component preparation and sterilization area Activities other than defined in the job responsibility are to be done, as per the requirement of HOD, by following HODs instructions and guidance.

Role & responsibilities Responsible for all process operation / activities during the shift as per CGMP. To maintain BMR/BPR/BCR etc. for record the batches. To co-ordinate with engineering department for the shift break down jobs. To handle manpower during the shift as per process operations. To work in safe work environment and ensure the sub ordinate are working in safe To maintain good housekeeping in respective area. To co-ordinate for the raw material from warehouse for issuing the raw materials. To co-ordinate to QC dept. for In- process and Intermediate testing. To fill the entire document legible. To record and maintain all the documents online as per CGMP.. Preferred candidate profile Education : B.sc Chemistry Suitable Candidates please share the cvs below mail id Ramesh.sanaboni@amneal.com 9550545943

Roles and Responsibilities Develop project plans, schedules, and budgets; track progress against targets using MS Project software. Manage engineering projects from concept to delivery, ensuring timely completion within budget and quality standards. Ensure compliance with CGMP regulations during manufacturing processes through effective documentation and risk mitigation strategies. Collaborate with cross-functional teams to identify potential risks and develop contingency plans for successful project execution. Provide technical guidance on SOPs (Standard Operating Procedures) development and implementation. Desired Candidate Profile B.Tech/B.E. degree in Any Specialization or M.Tech degree in Any Specialization required. Strong understanding of project planning, scheduling, cost optimization, regulatory compliance, risk mitigation, and budget management principles.

Job Title: FDA & International Pharma Compliance Consultant (Excipients, API & Ingredients & Formulations) Location: Kutch, Gujarat (Remote advisory with periodic on-site presence) Experience: 2025 years in pharmaceutical manufacturing and regulatory compliance Salary: Competitive Education: Bachelors or Master’s in Pharmacy, Pharmaceutical Sciences, Chemistry or related discipline Kindly get in touch for career advancement opportunities with us at rupsha.saha@antal.com Roles & Responsibilities Guide the upgrade and development of plant infrastructure and systems to achieve compliance with: WHO-GMP Regulatory requirements of Russia, Australia/New Zealand, African authorities Ultimate readiness for UK MHRA and US FDA audits Provide expert support on: WHO-GMP and GLP compliance for excipients, APIs, and formulation ingredients Equipment qualification (DQ/IQ/OQ/PQ) and cleanroom classification Process and cleaning validation Quality Management Systems (QMS), documentation (SOPs, BMRs, BPRs) and change control protocols Advise on regulatory documentation strategy for DMF and CTD/ACTD filings, including supplier qualification Assist in product selection and formulation pipeline development, identifying high-potential excipients and formulations for domestic and export markets Train and mentor QA, QC, production, and R&D teams on global pharmaceutical standards and best practices Desired Profile 20–25 years’ experience in excipients, API or formulations manufacturing, with a top-tier pharmaceutical company Proven track record of preparing and leading facilities through US FDA, MHRA or TGA audits Deep working knowledge of: ICH Q7/Q8/Q9/Q10 WHO GMP and EU GMP Annexes Indian D&C Act & Schedule M Hands-on experience supporting DMF submissions and familiarity with USP, EP, BP and IP Prior consulting or leadership roles serving regulated export markets Strong grasp of product lifecycle management, export documentation and quality risk management for emerging markets Tech-savvy, with exposure to digital QMS or e-BMR systems (desirable) Awareness of sustainability and EHS standards for global audit readiness Excellent cross-functional collaboration skills spanning production, QA/QC, R&D and supply-chain teams About Antal Antal International is a 30-year-old global executive search and placement firm with a network of over 800 people across 35+ countries, originally based out of the UK.

Preferred candidate profile Year of experience : 4 - 6 yrs Must have exposure on Review of documents MFR, BMR, BPR, QC specification, process validation data, stability summary report. Having exposure in licensing, Knowledge of GMP & GDP. Candidate must have exposure in regulatory market. Interested candidate may share resume at hr.plant@zuventus.com

Develop and implement QA strategies and systems. Lead and mentor the QA team. Ensure compliance with regulations and standards like ISO. Drive process improvements, manage audits, collaborate with teams, maintain documentation.

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.

Hello, Greetings for day! Please find the below JD Preparation/ review of standard operating procedure (SOP), calibration procedures, specifications, standard test procedures, general test procedures etc. Conducting training on specification and method of analysis, SOPS and calibration procedures. Handling of QMS documents like Change control, CAPA, Incidents, OOS, deviations, Out of calibrations, OOT etc. To ensure timely closure of documents like Change control, CAPA, Incidents, OOS, deviations, Out of calibrations, OOT etc. To investigate the laboratory error / incident and its impact on quality and analysis of all samples. Participating as a cross functional team member for investigation of any QMS related issues. To observe and maintain Good Laboratory Practices. To prepare / review documents like stability schedule, hold time study schedule, preventive maintenance schedule, calibration schedule. Co-ordination with outside calibration agencies. To prepare/review instrument qualification data. Coordinating with other departments for smooth functioning of laboratory. Arranging standards required for the analysis. Arranging columns required for analysis. To approved sign in TRF( Intermediate) ,GRN,Hold time sample, stability sample Ensuring training of departmental staffs as per job requirement. Attending training program as per CGMP training schedule. To take part in method validation/transfer/verification activity. To maintain discipline in the laboratory. To prepare the analysis request form and send the sample to contract laboratory for analysis. To take part in customer/regulatory/internal audits. Responsible for follow the health, safety & environment norms as per company policy & procedures. To monitor the good housekeeping practices in all quality control area. To co-operate in achieving the quality control objective. Preferred candidates should be form CDMO industry or somebody who has handled multiple API product and handled 50 members team. Interested candidates can share their update resume and below details on 'jyotsna.sable@aartipharmalabs.com' Total years of exp: Current CTC Exp CTC: Notice Period: Are you open for move to Gujarat: Do you have experience in CDMO/API Manufacturing Industry: what is the team size did you handle?

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere For 70 years, our team has driven meaningful innovations in kidney care As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients? that is what Vantive aspires to deliver, We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us At Vantive, you will become part of a community of people who are focused, courageous and dont settle for the mediocre Each of us is driven to help improve patientslives worldwide Join us in advancing our mission to extend lives and expand possibilities, Vantive: A New Company Built on Our Legacy Since last year, we have been on a journey to separate our Kidney Care segment into a standalone company Vantive will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us, At Vantive, you will become part of a community of people who are focused, courageous and dont settle for the mediocre Each of us are driven to help improve patientslives worldwide Join us as we revolutionize kidney care and other vital organ support, Job Summary Job Title Engineer IILab, Sterility Assurance & Microbial Sciences Location Whitefield, Bangalore Shift General This position will report to Sterility Assurance & Microbial Sciences Lab Manager and is primarily responsible for laboratory contract support This role will be responsible for the overall operation, maintenance and execution of various sterilization cycles in steam sterilizer The candidate should learn the technical aspects of sterilizer and should be able to troubleshoot routine challenges related to sterilizer by coordinating with vendors The candidate should have a strong understanding of the scientific aspects related to Microbiology and Sterility Assurance, Job Responsibilities Candidate working with a Device / Drug Company (Device preferred but would consider Pharma/ Biopharma)Microbiology & Quality Assurance/Control Should have a good knowledge of Regulations and GMP working environment Exposure to multiple products life cycle desirable, Contribute to technical feasibility analysis of complex research and design concepts including a lot of microbiology inputs for Sterility Assurance and related controls for the products, Good understanding of the Science & microbiology principles, guidance, regulations around sterilization validation & related to Sterility Assurance, Design, development & Technical Understanding of Microbial Method Validation & Sterilization Engineering principles for devices/ Solutions, Support Lab Manager by assuring contract laboratories documentation and internal lab documentation are audit ready and team can effectively respond to auditor inquiries, Work with Quality team to ensure adequate documentation, input into computer systems, and being the point person for addressing quality issues, Operation of steam sterilizer as per set procedure for various Sterility Assurance studies (Class-C & B studies), Prioritization of sterilizer cycles as per project need and urgency ensuring timely completion of project deliverables, To document all the sterilization study records manually or by using ELN templates, To learn and develop expertise in execution of different CCI methods (Air Under Water & Gurley), Responsible for calibration and maintenance of all laboratory equipment, Responsible for maintaining optimum inventory of lab consumables, Responsible for maintaining anytime audit readiness of Sterilization lab, Design and draft various study protocols as per project need, Equipment procurement and assure necessary validations and documentation, Support Lab Manager to maintain lab operations, Provide regular/timely updates to Sterility Assurance Management, Assure all work complies with Vantives QMS and cGDP/cGMP/cGLP practices, Perform standard Sterility Assurance assignments for application, validity and conformance to specifications, Utilize analytical process tools to solve complex process problems (e-g , FMEA, Risk Analysis, Process Modeling, Design of Experiments) Lead small project teams as needed to accomplish project objectives, Study and recommend techniques to improve existing products/processes and process controls, Provide sterilization support for Renal R&D projects and technical trouble shooting & to evaluate results relative to product requirements, definitions and/or program goals Analysis and evaluation of sterilization studies data and assist in the preparation of documentation using Good Documentation Practices (GDP), Employ appropriate techniques and methods to successfully conduct specific assignments within negotiated deadlines after receiving general instruction, Demonstrate working knowledge of basic technical theories and principles within area of expertise for routine tasks, Devise new approaches to complex problems through adaptations and modifications by use of standard technical principles, Maintain current knowledge of relevant Quality System Regulations and other regulatory requirements related to R&D (product development, design and safety) to ensure compliance in all research, data collection and reporting activities, Display a solid understanding of theories/practices utilized by other disciplines outside primary area of expertise, Ability to convince management on courses of action with minimal assistance using both written and verbal methods, Knowledge around microbiological aspects of biological indicators, Adventitious Agents and related microbiological concepts, Qualifications Masters degree in a scientific discipline (Microbiology/Technology/ Science/ Pharmacy) with minimum 6 years or BS with minimum 8 yearsexperience in sterilization validation or equivalent, Prefer experience with Sterilization, Global sterilization regulations & TQM methods (e-g "six sigma") Display a solid technical understanding of Microbiological principles and qualification practices & application of these principles on individual/small projects, Technical writing skills, remote support for projects, strong interpersonal skills and a quick adaptive mindset for the new technologies, Strong Microbiology background and experience, Demonstrated ability to utilize resources available to ensure compliant and required documentation for contract testing laboratories and the internal R&D microbiology department, Experience managing multiple simultaneous projects and work activities, In-depth knowledge of cGDP/cGMP/cGLP practices and compliant documentation, Effectively operates in, and capable of facilitating, cross-functional teams, Knowledge of Terminal sterilization and/or pharmaceutical industry, Skills Excellent English verbal and written communication skills, skilled to coordinate with global stake holders and support across the different time zones, Proficient with Sterilization principles and related testing for Biological indicators etc Hands on experience cycle design and development and performing the sterilization studies for devices with use of PCD /biological indicators, Highly adept at grasping and solving complex problems using root-cause analysis techniques, Ability to objectively identify technical solutions and make sound decisions Project management experience for Quality & value improvement projects Self-driven, resourceful, and able to work on multiple projects and priorities, Strong organization, attention to detail, and documentation skills, Strong acquaintance with technology, QMS tools and collaboration tools over the web: e-g Trackwise, Document tools, WebEx, Teams, Microsoft Office products, etc Reasonable Accommodation Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information Form Link Recruitment Fraud Notice Vantive has discovered incidents of employment scams, where fraudulent parties pose as Vantive employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information To learn how you can protect yourself, review our Recruitment Fraud Notice, Show more Show less

Handle BMR and batch repacking records, Verify daily balance checks and calibration activities, Maintain production records, Perform and verify line clearance at manufacturing and packing stages, Issue and retrieve production documents Required Candidate profile Graduate candidates with 1 -2 Year experience and knowledge about cGMP Practice, QMS tools knowledge, Production and Manufacturing documentation process. We are looking for local candidates ONLY.

Division Manufacturing Department Manufacturing Employment Type Permanent Job Purpose Execute the production operations in line with safety and GMP requirements to meet the manufacturing targets in shift Accountabilities Operate the equipment efficiently without error and deviation as per SOP to meet shift targets Provide suggestions for optimization of processes to manufacture quality product III Execute and update online documentation to meet cGMP requirements Deliver training to workmen and adhere cGMP and safety guidelines in production process to ensure smooth operations Education Qualification Diploma in Pharmacy / Mechanical Engineering Relevant Work Experience 2 years of experience in a manufacturing organisation preferably in pharmaceutical industry Competencies/Skills Collaborate to Succeed Innovate to Excel Perform with Accountability Lead with Empathy Act with Agility Strong Domain Knowledge People Management Job Location Rangpo Shift Hours

Carry out the manufacturing operations according to the BPCR provided by QA department Perform the Operations in accordance to the established SOPs and cGMP. To maintain for Good documentation practice .To execute Production planning schedule. Required Candidate profile < Qualification : B.sc /M.sc(Chemistry)/B. Pharmacy/B. Tech ( Chem engg) - Any chemistry Background. < Having Pharma Experience of 2- 8 Years of experience. Perks and benefits Free Bus , Canteen, Pf

Position Assistant Manager - Quality Control Business Unit / Function Department - Quality Control Location Bharuch; SEZ;;;; Reports to QC Head; Summary of Job (Purpose/ objective of the job Department Organogram to be enclosed) candidate is required having complete experience in API/Bulk/ Intermediates industries as per global regulatory requirements and responsible for implementation and compliances of 21CFR-Part11, ICH-Q7A, cGMP, WHO-GMP, ISO9001, FSSC, HACCP / global QMS requirements at SEZ site. Key Responsibilities (Performance Indicators) Regularize the QC activities as per cGMP requirements. Regulatory and Pharmacopeia requirement for lab compliance. Review of hybrid and electronic data for IPQC and FG analysis.; Analytical method validation, OOS and OOT.; Knowledge about IMS system (ISO 9001:2015, ISO 14001:2015 OHSAS 18001:2007, and cGMP. Analytical skill for QC instrument, i.e. GLC, HPLC, UV-Visible, FTIR, ICP, K/F, Melting point etc. Co-ordination with QC staff, R and D, Commercial and production for quality and dispatch related activities for on time dispatches. Resolve the trouble shooting related to QC activities.; Training to subordinate and employment of 21 CFR Part 211, 111 with data integrity (Part-11) compliance in lab. Awareness about responsible care (Environment, Health, Safety and Security) No. of Reportees 2-3 numbers Qualification and Experience M.Sc. (Chemistry) with 8-12 yrs. y Competencies; (Technical, Functional and Behavioral) Responsible for implementation and compliances of 21CFR-Part11, ICH-Q7A, cGMP, WHO-GMP. Hand-on experience as Reviewer of electronic data and hybrid system in regulatory environment (US-FDA, WHO etc.) Knowledge about 21 CFR Part 211, 111 with data integrity (Part-11)

The Junior Executive – Warehouse will support day-to-day operations within the warehouse to ensure the proper handling, storage, and dispatch of pharmaceutical products in compliance with regulatory and company standards. The role involves inventory

Role & responsibilities Job Title: Sr. eCompliance Specialist/Manager Education (minimum/desirable): Degree in Life Sciences, Pharmacy, Engineering, or Information Technology; or similar; advanced degree preferred. Languages: Fluency in English (oral and written), additional language(s) a plus. Experience/Professional requirement: 5-10 years of overall experience, and a minimum 5 years of relevant experience in the Pharmaceutical Industry and in particular within regulated functions such as IT Quality and Compliance; CSV compliance. Profound understanding of global regulations and Health Authorities expectations governing computerized systems incl. computerized systems validation, lifecycle management and 21 CFR Par 11 requirements, EMA Annex 11. Experience in the development, implementation, and lifecycle management of computerized systems in regulated environments Experience in quality management of onsite, Cloud, SaaS platform, mobile and digital application used in regulated environments Highly experienced in the operational management of GxP solutions including its related technologies to support the operation. Good understanding in system application management, its Quality support approach and industry best practices (ITIL, ITSM, etc.) Experience in the development, implementation and lifecycle management of key computerized systems in the Pharmaceutical Development, Manufacturing, Quality, Commercial and Infrastructure space (e.g. ERP/SAP, MES, Trackwise, CRM, IAM, etc.) Experience in ensuring the compliance of GxP application validation and Infrastructure Qualification Successful cross-divisional/functional work with complex international teams Proven ability to adjust to multiple demands, shifting priorities and unexpected events while maintaining a positive work attitude Proven ability to influence without hierarchical authority and build trusted partnerships Proven self-starter with experience in initiating and delivering projects and processes Excellent communication, interpersonal skills, and critical thinking COMPANY : SANDOZ LOCATION : HYDERABAD CONTRACT FOR 6 MONTHS WILL BE RENEWED ON PERFORMNCE SHARE RESUMES TO NEDUNURI.SAIKUMAR@MANPOWER.CO.IN

Preferred candidate profile MSc Microbiology with 1-5 years of experience in environmental monitoring in GMP regulated areas, with hands-on experience in operating microbiology instruments like water bath, weighing balance, pH meter, Hot air oven, Bio safety cabinets, HPHV Steam sterilizer, Dry block incubator. Role & responsibilities To perform Environmental Monitoring in required areas of GMP facility. To prepare Disinfectant solutions and Reagents. To handle the Microbiology instruments like water bath, weighing balance, pH meter, Hot air oven, Bio safety cabinets, HPHV Steam sterilizer, Dry block incubatorbut not limited to. To Receive, Storage and Handling of Microbiology consumables. To Perform fumigation/fogging in the clean rooms. To Sterilize the porous and non-porous goods loads. To Personnel gowning Qualifications for aseptic areas. To participate in media fill activities. To Prepare Environmental monitoring trends. Responsible for Stock verification and indents. To handle biological indicators and Bio balls and Endotoxin test kits. To perform NVPC monitoring in clean rooms. To perform sterilization and decontamination cycles on daily basis To Involve in regulatory audits and Customer audits.

quality checks on raw materials, in-process, and finished product proper documentation as per GMP standard stability studies, sampling, and lab testing compliance with SOPs, regulatory, and safety guideline audits and assist in CAPA implementation

Job Summary We are looking for a detail-oriented engineering team member to coordinate preventive maintenance schedules, manage breakdown records, and ensure adherence to SOPs, critical for maintaining operational efficiency and equipment reliability. This role plays a pivotal part in inventory control, and CAPA closure, contributing to seamless production operations, compliance with regulatory standards, and effective resource utilization. Roles & Responsibilities • To maintain the facility as per cGMP, and GMP requirements of country where product is being exported and strict adherence of Good Engineering practices during task execution. Can handle Water system operation and maintenance. Can handle HVAC system operation and maintenance. Must have knowledge of RO membranes & EDI replacement and its troubleshooting. Must Have knowledge of SCADA system and cGMP documentation. Spare management, Vendor management, MIS reports etc. Do the planned work on time. e.g. PM, PR, PO's etc. To carry out upkeep round as per schedule and updating of the records. To follow the instructions relating to engineering operations and to ensure their strict implementation. Ensuring continuous improvements and engineering excellence. To follow good documentation practices. To ensure EHS procedures and practices are followed at site to achieve zero lost time accident and compliance. Responsible for documentation related to upkeep of water system and HVAC. Must have knowledge of RCA, FMEA, Change Control, deviation and other GxP documentation. You will be accountable for ensuring implementation of Good Engineering Practices (GEP) at Site. Qualification Educational qualification : A Diploma or a B.Tech in Mechanical or Electrical Engineering Minimum work experience : 5 to 8 years Skills & attributes: Technical Skills Responsible for documentation related to upkeep of water system and HVAC. Responsible of Operation oif water system and HVAC Managing contractors at site. Their Work permits etc. Water system Maintenance and upkeep of HVAC in proper manner. Spare management for water system and HVAC Spares Experience in managing RO Mem. and EDI maintenance plans. Ability to manage maintenance budget of an area/unit. Knowledge of GMP and GEP. Behavioural skills • Communication and collaboration skills to coordinate with cross functional teams, external contractors and agencies. • Attention to detail to ensure preventive maintenance, documentation, and inventory control. • Commitment to quality and compliance. Additional Information About the Department Global Manufacturing Organisation (GMO) At Dr. Reddy's Laboratories, we are dedicated to making a meaningful impact on global healthcare through precision manufacturing and innovation. With a legacy of excellence, we are a leading force in the pharmaceutical industry. We operate 19 state-of-the-art manufacturing plants across Hyderabad, Vizag, Baddi, Mexico, Shreveport, and Mirfield, comprising 8 OSD facilities, 3 Injectables facilities, and 8 API facilities. Benchmarking manufacturing processes and continuous operational excellence are at the core of our capability to deliver quality medicines to our patients in 66 countries. We manufacture a portfolio of complex APIs and 1,150+ drug master files across key therapy areas such as Oncology, Cardio-vascular, Central Nervous System and Anti-Diabetes. he World Economic Forum has recognised our largest manufacturing facility in Bachupally, Hyderabad, as part of its Global Lighthouse Network. We aspire to be the most efficient pharma operations in the world. Our productivity improvement and digitalisation efforts are key to staying competitive, meeting business imperatives, and meeting our ambitious ESG goals. Building such ‘factories of the future’ is integral to innovation and to build healthcare of the future. Benefits Offered At Dr. Reddy’s we actively help to catalyse your career growth and professional development through personalised learning programs. The benefits you will enjoy at Dr. Reddy’s are on par with the best industry standards. They include, among other things and other essential equipment, joining & relocation support, family support (Maternity & Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, life coverage for yourself. Our Work Culture Ask any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we’re always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic. For more details, please visit our career website at https://careers.drreddys.com/#!/

Job Summary We are seeking an associate for the Quality team responsible for conducting sampling and analysis of packaging and raw material samples. The role involves ensuring accuracy in documentation, adherence to safety procedures, reporting discrepancies, and maintaining lab safety. Roles & Responsibilities • You will be responsible for conducting sampling and analysis of raw material samples as allotted by the group leader. • You will also be responsible for the proper use and care of instruments or equipment as instructed in relevant SOPs (Standard Operating Procedure), including cleaning before and after analysis. • You will adhere to safety precautions and procedures during analysis. • Your responsibilities include placing SOP/STP/reference standards at their designated locations after analysis, and reporting discrepancies or incidents promptly to the Group Leader. • Lab safety, following JSA (Job Safety Analysis), and using proper PPE (Personal Protection Equipment) at the workplace are emphasized. • You will oversee the handling and upkeep of the chemical and solvent store, preparation of Spec-check, catalog, and result entries, as well as maintaining volumetric solutions and reagents. • Your role also includes preparation of out lab testing samples (as required), timely destruction of samples as per SOP and any additional responsibilities assigned by the Group Leader. Qualification Educational qualification: A Bachelor’s degree in Chemistry, Analytical Chemistry, or a related field Minimum work experience : 2 to 5 years of experience in a laboratory setting, preferably in the pharmaceutical or related industry Skills & attributes: Technical Skills • Proficient in various analytical techniques, including sampling and analysis of raw material samples. • Experience with the operation and maintenance of analytical instruments like HPLC, GC, Potentiometer, Particle Size Analyzer, XRD, ensuring proper use and care as per SOPs. • Competent in LIMS activities related to sample tracking, documentation, and data entry. • Knowledgeable about cGMP, SOPs, and STPs, ensuring accurate documentation and adherence to specifications. • Adheres to safety precautions and procedures during analysis, emphasizing the importance of lab safety, JSA (Job Safety Analysis), and proper use of PPE (Personal Protective Equipment). • Expertise in handling and upkeep of the chemical and solvent store, including the preparation and maintenance of volumetric solutions and reagents. Behavioural Skills • Keen attention to detail in analysis and documentation, ensuring accuracy in all tasks. • Effective communication and collaboration skills for communicating with the Group Leader, reporting discrepancies, incidents, and providing timely updates. • Takes initiative in ensuring the proper use and care of instruments, timely destruction of samples, and other assigned responsibilities. • Demonstrates problem-solving skills in addressing discrepancies, incidents, and ensuring smooth laboratory operations. • Upholds ethical standards, compliance with SOPs, and follows regulatory requirements in all activities. Additional Information About the Department Global Manufacturing Organisation (GMO) At Dr. Reddy's Laboratories, we are dedicated to making a meaningful impact on global healthcare through precision manufacturing and innovation. With a legacy of excellence, we are a leading force in the pharmaceutical industry. We operate 19 state-of-the-art manufacturing plants across Hyderabad, Vizag, Baddi, Mexico, Shreveport, and Mirfield, comprising 8 OSD facilities, 3 Injectables facilities, and 8 API facilities. Benchmarking manufacturing processes and continuous operational excellence are at the core of our capability to deliver quality medicines to our patients in 66 countries. We manufacture a portfolio of complex APIs and 1,150+ drug master files across key therapy areas such as Oncology, Cardio-vascular, Central Nervous System and Anti-Diabetes. he World Economic Forum has recognised our largest manufacturing facility in Bachupally, Hyderabad, as part of its Global Lighthouse Network. We aspire to be the most efficient pharma operations in the world. Our productivity improvement and digitalisation efforts are key to staying competitive, meeting business imperatives, and meeting our ambitious ESG goals. Building such ‘factories of the future’ is integral to innovation and to build healthcare of the future. Benefits Offered At Dr. Reddy’s we actively help to catalyse your career growth and professional development through personalised learning programs. The benefits you will enjoy at Dr. Reddy’s are on par with the best industry standards. They include, among other things and other essential equipment, joining & relocation support, family support (Maternity & Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, life coverage for yourself. Our Work Culture Ask any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we’re always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic. For more details, please visit our career website at https://careers.drreddys.com/#!/