1773 Gmp Jobs - Page 47

Role Responsibilities: Conduct food safety audits per FSSAI Schedule 4 norms Generate and revise audit reports based on technical reviews Ensure timely submission of audit packs Travel to client locations and plan audit schedules Key Deliverables: Completion of scheduled food safety audits Accurate, compliant audit documentation Adherence to GHP/GMP/HACCP protocols Coordination with clients for audit planning and follow-up

Job Summary: Perform and report the analysis of In-Process samples, finished products, Stability samples and Cleaning Validation. Job Responsibilities: To ensure timely completion of analysis and data completion for the same. To be responsible for all activities in the Quality Control Laboratory, including cGLP, documentation and implementation of departmental quality systems. To perform the in-process/finish product/stability testing of laboratory Batches, Commercial batches, other stability samples and Cleaning validation. To Prepare Stability Trend Reports for Laboratory samples. To collect and maintain various laboratory samples. To generate and maintain records related to laboratory samples. Works as a member of a team to achieve all outcomes. Performs all work in accordance with all established regulatory and compliance and safety requirements. Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion. To assist the Senior Analyst / Team Leader/Group Leader in the day-to-day functioning of the Quality Control Laboratory. 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 duties as assigned. Job Requirements: Education M.Sc\BPham or any equivalent degree Knowledge, Skills and Abilities Effective command over verbal and written communication with good interpersonal skills. Command on Microsoft-Office (Word, Excel). Able to prioritize the tasks. Best in effective planning of work activities to meet the time lines. Experience Minimum 2 to 4 years of experience in GMP regulated pharmaceutical industry.

Harman Finochem is looking for a skilled professional to join our Formulation Analytical Development (ADL) team. If you have hands-on experience with a range of analytical instruments, expertise in method development and validation, and a strong commitment to GxP principles, we encourage you to apply! Key Responsibilities Analytical Testing: Perform individual analysis for both In-process and stability samples according to the established plan. Instrument Proficiency: Operate, troubleshoot, and calibrate various analytical instruments including HPLC, GC, Dissolution apparatus, UV, FT-IR, and Potentiometer . Method Development & Validation: Conduct Method Validation and Method Development for new products, covering tests such as Cleaning, Assay, Residual Solvents, Dissolution, and Organic Impurities. Solution Management: Oversee the preparation, proper storage, and usage of Volumetric, Reagent, Standard, and Indicator solutions. Calibration & Verification: Perform calibration and verification of all instruments and equipment as per the defined calibration schedule. Quality Compliance: Strictly adhere to Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and Good Documentation Practices within ADL. Preferred Candidate Profile Education: Post-Graduation in M.Sc. Analytical Chemistry or M. Pharma. Industry Background: Experience from a Pharma Background Industry is essential. Instrument Knowledge: Proficiency in HPLC/GC, Dissolution, UV, FT-IR, and Potentiometer. Familiarity with troubleshooting and calibration of these instruments. Knowing GCMS and LCMS will be an added advantage. Analytical Skills: Strong ability to develop and validate analytical methods. Perks and Benefits As per company policy.

Eurofins Scientific is an international life sciences company that provides a wide range of analytical testing services to clients across multiple industries. From food and pharmaceuticals to environmental and cosmetic products, Eurofins ensures safety, authenticity, and accuracy. With a global presence and over 900 laboratories, Eurofins is a leader in food, environmental, pharmaceutical and cosmetic product testing, as well as in genomics, clinical studies support, and other specialized diagnostic testing. Applies GMP/GLP in all areas of responsibility, as appropriate Demonstrate and promote the company vision Regular attendance and punctuality Read and understand analytical procedures Review documentation, generated data, calculated results, and final reports according to departmental, corporate, and client SOPs Gain a technical understanding of the techniques in which review is being performed Use MS Windows applications such as EXCEL, Word, Access, Outlook email Conducts all activities in a safe and efficient manner Performs other duties as assigned Qualifications M. Pharm (Pharmaceutical Analysis) / M. Sc Chemistry Additional Information Experience level : 0 - 2 years in Bio/Pharmaceutical Analysis Key Candidate Attributes: Self-motivation; excellent quality of work and attention to detail Ability to communicate effectively with coworkers and internal/external clients Ability to learn new tasks quickly and to move easily from task to task Ability to handle prioritization and multiple tasks simultaneously Ability to use a personal computer and learn necessary programs Good communication skills (oral and written) Organizational ability and good judgement Science background/education and/or laboratory experience

Eurofins Scientific is an international life sciences company that provides a wide range of analytical testing services to clients across multiple industries. From food and pharmaceuticals to environmental and cosmetic products, Eurofins ensures safety, authenticity, and accuracy. With a global presence and over 900 laboratories, Eurofins is a leader in food, environmental, pharmaceutical and cosmetic product testing, as well as in genomics, clinical studies support, and other specialized diagnostic testing. Position Summary: Ensuring that the client receives quality data by reviewing laboratory data for accuracy, clarity, and adherence to GMP and/or GLP regulations Essential Duties and Responsibilities Applies GMP/GLP in all areas of responsibility, as appropriate Demonstrate and promote the company vision Regular attendance and punctuality Read and understand analytical procedures Review documentation, generated data, calculated results, and final reports according to departmental, corporate, and client SOPs Gain a technical understanding of the techniques in which review is being performed Use MS Windows applications such as EXCEL, Word, Access, Outlook email Conducts all activities in a safe and efficient manner Performs other duties as assigned Qualifications Basic Minimum Qualifications: To perform this job successfully, the individual must be able to perform each essential duty satisfactorily. The requirements below are representative of the knowledge, skill or ability required. Education/Experience: A masters degree in microbiology Additional Information Experience level :02 years of pharmaceutical experience preferred. Key Candidate Attributes: Self-motivation; excellent quality of work and attention to detail Ability to communicate effectively with coworkers and internal/external clients Ability to learn new tasks quickly and to move easily from task to task Ability to handle prioritization and multiple tasks simultaneously Ability to use a personal computer and learn necessary programs Good communication skills (oral and written) Organizational ability and good judgement Science background/education and/or laboratory experience

PURPOSE AND RESPONSIBILITIES OF THE POSITION Carry out audits at suppliers in accordance with the reference regulations, Eurofins Sisthema procedures and specific customer requests. Draft audit reports within agreed timelines. DESCRIPTION OF THE ACTIVITIES Macro Areas of Activity Pre-audit Management of pre-audit documents Preparation of the audit agenda Collaboration in travel preparation Audit Conducting the audit Post-audit Drafting of audit reports and audit comments. Drafting amended documents following customer request Evaluation of the CAPA plan CROSS-FUNCTIONAL (INTERNAL AND ETERNAL) RELATIONS Roles and Areas with which links are held Customer Preparation of the audit agenda, drafting of the audit report and audit comments, make any necessary corrections and evaluation of the CAPA plan. Supplier Preparation of the audit agenda, conduct of the audit QA Reporting non-compliances Finance Expenses reporting Audit Sales & Planning Specialist Preparation of the agenda Collaboration for audit planning and travel preparation Audit Sales & Planning Assistant Preparation of the agenda Collaboration for audit planning and travel preparation Audit Customers Manager Collaboration in the technical review of the audit reports. Collaboration following customer requests Audit Operations & Audit Sales Man Collaboration in the auditor qualification process. Reporting issues emerged during the audit Qualifications Educational qualification- Scientific degree (preferably Pharmacy, Chemistry and Pharmaceutical Technology, Chemistry) Technical Audit Report Writing skills are mandatory. Previous experience- Experience of minimum 10 plus years in the field of pharmaceuticals, medical devices and / or cosmetics (QA, Regulatory Affairs, QC, Consulting) Conducting at least 10 supplier audits and/or internal audits Knowledge of- EU GMP part I & II, ISO 9001, ISO 13485, ISO 15378, ISO 22716,CFR21 part 210,211, EU GDP, IPEC guidelines, English language level C, Microsoft Office Specific technical practical skills (know-how) - Conducting Audits of Quality Management Systems Transversal skills- Attention to order and Quality Self-control Autonomy Analytical capacity Customer and result orientation Confidentiality Compliance with planned timelines Additional Information Use of equipment, utilities, software -Microsoft Office, LIMS, SAP, CDS system. Certifications -Quality Management System, Computer System Validation, Six Sigma, ISO

Applies GMP/GLP in all areas of responsibility, as appropriate Demonstrate and promote the company vision Regular attendance and punctuality Read and understand analytical procedures Review documentation, generated data, calculated results, and final reports according to departmental, corporate, and client SOPs Gain a technical understanding of the techniques in which review is being performed Use MS Windows applications such as EXCEL, Word, Access, Outlook email Conducts all activities in a safe and efficient manner Performs other duties as assigned

Applies GMP/GLP in all areas of responsibility, as appropriate Demonstrate and promote the company vision Regular attendance and punctuality Read and understand analytical procedures Review documentation, generated data, calculated results, and final reports according to departmental, corporate, and client SOPs Gain a technical understanding of the techniques in which review is being performed Use MS Windows applications such as EXCEL, Word, Access, Outlook email Conducts all activities in a safe and efficient manner Performs other duties as assigned

Key Responsibilities: Perform visual and measurement inspections of raw materials and finished products. Conduct tests according to quality control guidelines. Document inspection results and report non-conformities. Collaborate with production team to resolve quality issues. Maintain cleanliness and calibration of testing equipment. Qualifications & Skills: Diploma or degree in quality management, engineering, or related field preferred. Attention to detail and strong observational skills. Familiarity with quality standards (ISO, GMP, etc.). Good documentation and communication skills.

Include general job responsibilities, required job skills, and required soft skills. Use bulleted lists. Allow job seekers to quickly read information in bulleted descriptions. Insert text carefully. Use a flat text editor (such as TextEdit or Wordpad) to copy and paste text; avoid using Microsoft Word (since it contains hidden characters). Avoid links. Links will get your job posting caught in spam filters on all job boards.

Desired Candidate Profile 2- 4 years of experience in machine handling, equipment maintenance, or a related field. Roles: Should have a good understanding of the industry and sound knowledge of their trade. Basic knowledge of safety protocols and good manufacturing practices is essential. Apprentice experience preferred, with at least 1 year of relevant exposure.

Summary Plan and perform scientific experiments (or pilot plant processes) for the preparation and timely delivery of drug substances (DS), drug products (DP), processes and procedures in collaboration within a multifunctional project team coordinated by a Project leader. Contribute to maintenance of lab instruments/infrastructure. Plan and perform scientific experiments (or pilot plant processes) for the development and timely delivery of drug products (DP), processes and procedures in collaboration within a multifunctional project team coordinated by a Project leader. Contribute to maintenance of lab instruments/infrastructure. Support development projects aiming the development of stable, bioequivalent, robust and cost competitive dosage forms -Design and manage experiments/batches for simple/low complexity products under supervision, provide related scientific documentation Plan and execute experiments in agreement with quality risk management and GDevP /GMP -Assists in the preparation of and reviews of the technological part of dossier About the Role Major accountabilities: Meet quality, quantity and timelines in all assigned projects. Plan, organize, perform and document scientific experiments /plant activities in collaboration with experienced team members if necessary. Seeks proactively for support and coaching from Project Leader, Scientific Expert or other team members during the whole process if necessary. Plan and perform scientific experiment /plant activities and plan, perform and contribute to project related scientific/technical activities under minimal guidance from more experienced team members under guidance. (eg. contribute to interpretation and report results) -Provide efficient and robust processes for the manufacture and /or specialized facilities with adequate guidance. Provide raw data documentation, evaluation and results interpretation. Propose and provide input for the design of next experiments. Optimize existing analytical methods and develop more efficient ones. Generate lab procedures, reports and /or instructions and/or SOP s Adherence to quality (cGxP, data control), ethical, health, safety, environment (HSE), and information security (ISEC). Review and verify raw data generated by others -Perform the transfer of procedures to other departments or qualification/validation of procedures under supervision-Optimize or troubleshoot existing methods/processes and develop new methods /processes based on published methods/processes under supervision -Address and solve problems of high complexity under minimal supervision. Provide solutions on deviations and unexpected results from experiments. Participate in function-specific teams and fulfil assigned project tasks and responsibilities under supervision. Actively maintain laboratory inventory (e.g. chemicals, raw materials, consumables) within own area of responsibility -Collaborate within and with other groups and sites. Schedule and perform maintenance and qualification of instruments /equipment including responsibility for selected equipment. Key performance indicators: Successful execution of assigned tasks within given timelines at expected quality; right first time and right in time -Adherence to appropriate standards as defined in Quality Manual, SOPs, ethical, health, safety, environment (HSE), and information security (ISEC) guidelines -Adherence to quality, quantity and timelines for all assigned tasks. Ensures reproducibility of experiments and results. Minimum Requirements: M.Sc. /M. Pharm/ Ph.D. with relevant experience. Good knowledge of English and site language (oral and written). Recognized expertise in a GxP area and broad scientific as well as technical and strategic background. Demonstrated successful experience with working in interdisciplinary and cross-cultural teams. Demonstrated leadership and advanced coaching and mentoring skills. Thorough knowledge of relevant SOP, GMP and Novartis regulations and policies if applicable. Excellent communication/presentation skills and scientific Benefits and Rewards: Read our handbook to learn about all the ways we ll help you thrive personally and professionally:

1) Preparation, modification, and implementation of SOPs at warehouse. 2) Ensure compliances for cGMP or any other regulatory requirements, including EHS requirements 3) Ensure maintenance and upgradation of warehouse facility. 4) Report any quality concerns or suggestions for improvements to seniors. 5) Supervise to ensure all tasks and activities shall be executed as per the applicable SOPs. 6) To co-ordinate with Purchase, Production departments, Quality control, and Quality Assurance department for raw material and packing material activities and concerns for improvement. 7) To identify problem and immediate corrective action by suggesting solution through designated 8) To maintain warehouse for online compliance of Internal and External audit of GMP, EHS, Statutory, Legal audit etc

KEY TASKS & RESPONSIBILITIES Primary contact for Packaging QA issues Monitor Packaging s overall safety and quality Ensure the completion of QA review of Packaging process orders and Packaging forms Lead packaging inventory counts Maintenance of master inspection characteristics for Packaging processes in ERP. Monitor Compliance with QMS, conducting regular audits of procedures and documentation Ensure timely entry QC Test results into ERP and co-ordinate with QA Manager on the release of dried harvest lots Develop and implement continuous improvement initiatives in Packaging operations, Coordinate with QA Manager and GMP Advisor to develop, implement, and maintain QMS systems and GMP for Packaging processes Perform risk assessments in Packaging and investigate non-compliances and deviations as required Provide direction supervision of Packaging QA Technician(s), provide training, feedback, and ensure completion of assigned tasks With help of the QA Manager, create and deliver performance targets and evaluations, including providing regular and consistent feedback to team Ensure adherence to GMP and SOPs during packing operations. Assist to QA manager during internal, external and customer audits by providing relevant records and data. Provide on-floor guidance to production teams on quality practices. Implement audit recommendations and support to QA team for closure of observations. Monitor personal hygiene and gowning in packing area. Identify, record and report deviations or non-conformances in packing activity. Ensure line/area clearance before packing startup.

This role is responsible for developing and implementing health and safety plans, enforcing policies, and evaluating practices and facilities to ensure compliance with legal guidelines. They conduct training sessions, monitor compliance, investigate accidents, and provide recommendations for improvement. They also communicate guidelines to employees, report on health and safety issues, and develop relevant policies to maintain a safe workplace. Their focus is on promoting occupational health and safety and minimizing risks for employees. Job Description About the Role: Implement and enforce HSSE policies, procedures, and practices in accordance with company, local, and international standards. Conduct daily site safety inspections and ensure compliance with safety requirements during civil, structural, MEP, HVAC, cleanroom, and utility works. Monitor site activities for hazards, unsafe practices, and ensure corrective actions are implemented. Conduct risk assessments, job safety analysis (JSA), and toolbox talks regularly. Ensure compliance with statutory regulations (Factories Act, OSHA, environmental regulations, etc.). Maintain and update site safety documentation including work permits, incident reports, safety checklists, and audit logs. Coordinate emergency preparedness drills, firefighting training, and first-aid programs. Assist in the investigation of incidents, near-misses, and prepare root cause analysis and CAPA reports. Ensure that contractors and workers follow PPE protocols, work at height safety, and hazardous material handling. Support safety audits, inspections, and ensure closeout of audit findings and safety observations. About You: Diploma/Degree in Engineering or Science with specialized training in Industrial Safety (e.g., NEBOSH, IOSH, ADIS). Prior experience in EHS/HSSE roles, preferably in High Voltage Products (Breakers/disconnectors and switches) Manufacturing Plant construction projects. Strong knowledge of GMP/EHS compliance in pharma or life sciences environments. Familiarity with work permit systems, confined space safety, scaffolding, electrical safety, and emergency preparedness. Excellent observation, communication, and incident-reporting skills

1.Monitoring of cGMP and GLP compliance and compliance to applicable regulatory requirement and filing commitments. 2.Resopnsible for investigation of LIR (Incident / OOS/ OOE). 3.Analysed data review. 4.Analysis of Finished, In process, Process validation, Cleaning Validation samples. 5.To report any OOS/Incidence results to immediate supervisor/Head of department. Job Role : GLP Analyst Block 2 1.To perform daily verification/calibration of all quality control laboratory instruments. 2.To ensure destruction of unused solid and liquid samples, to discard left over samples. 3.To ensure all QC activities are being performed as per approved specification/ GTPs/ SOPs. 4.Laboratory chemical management. 5.Laboratory Instrument qualification.

Roles and Responsibilities Conduct quality analysis of raw materials, in-process samples, finished products, and stability studies to ensure compliance with specifications. Prepare BMRs (Batch Manufacturing Records) for new batches and review them before release. Perform microbial testing on raw materials, bulk samples, and finished products using standard methods like MLT (Microbial Limit Test). Ensure proper documentation of all quality activities, including test results, observations, and actions taken. Collaborate with cross-functional teams to resolve quality issues related to product development, manufacturing processes, or packaging.

Job Description Candidate should the exposure for handling the Bottle packing line. Should have the work experience in Regulatory plant. Faced the USFDA, MHRA,TGA inspection. Good Communication skill. Having the SAP knowledge. Work Experience 3 to 05 years' Experience. Education Graduation in Pharmacy Competencies

Role & responsibilities RESPONSIBILITIES Product is maintained in constant state of validation Product history is documented and available and current since transfer from development to date Continuously improving CpK (process capability)/ Ppk (Process Performance) Degree of standardization of product process. Genotoxic and elemental impuirty assessment in all APIS Nitrosamine impuirty assessment Transport risk assessment Investigation and data analysis of Customer Complaints, Recalls, Recurring Deviations and OoS, OoE Out of Specification, Out of Expectation. Success rate of Health Authorities inspections. Completeness of Reg CMC dossier Effective CAPA. Continuously improving Yield. Technical reports executed on time and with the right expectations. Preferred candidate profile Transfer OUT process Provide the necessary data for the technical activities involved in transferring out a product, focusing on existing knowledge, through the appropriate documentation and supporting at the receiving site as needed. Investigations/improvement on product Initiate and support investigations and improvement projects (quality, efficiency), based on the above data analysis, involving cross-functional teams Actively participate and represent their product(s) in the relevant committee (e.g. Product Stewardship Committee), where the improvements on weak point products are planned, prioritised and monitored Ensure that technical batches generate sufficient process knowledge by thoroughly testing critical variables and use the output to verify critical process parameters Validation: Provide all necessary information to perform the validation documentation, align with stability expert and QC labs to organize the stability samples Supports Validation Lead and Experts to assess need and plan validations / re-validations / verifications / Annual Monitoring Batches, consulting approving and reviewing the process validation master plan, together with the Validation Lead or Validation Experts Approves both Validation Protocols and Report Testing Monograph oversight: Ensure oversight on Testing Monograph, liaising with Analytical Services to ensure consistency of content Change control: Ensure oversight of technical changes and lead end- to- end change control management related to technical issues, working cross- functionally as required. Training: Own the Training Curriculum for its Job Profile and provides the necessary training and support to new associates joining this position Regulatory Filings: Act as the interface for the site with the relevant Health Authorities for technical issues. Review and releases regulatory proposals or information required for regulatory filings. Genotoxic impuirty assessment, Nitrosamine impuirty assessment, Elemental impuirty assessment and Transport risk assessment report. Audit support: Maintain their work in inspection readiness level and to provide the necessary support in any internal or external audit Key process safety related roles and responsibilities Responsible for the safe operation of one or more processes and the appropriate training of the operators in the process. Facilitate team which carries out ZHA before introducing the process. Prepare overall plan for Integrated Management System documentation, control and its implementation within the department in close coordination with respective HODs including implementation of Olon Health, Safety & Environment system as per CHSE guidelines. As appropriate, responsible for implementation of, compliance to and governance of practices specifically prescribed to this role by the Novartis Manufacturing Manual. Perks and benefits

Job Description Labware 7. LIMS implementation, Master data creation, Validation. Caluculation configurations. CSV documentations, Test Script review, Instrument integrations. LIMS trouble shooting and resolutions. QAMS activities, CCP, CAPA, Deviation investigation. Work Experience 4-7 years of experience in QC and LIMS Implementation Education Post Graduation in Analytical Chemistry or Analytical Chemistry Graduation in Pharmacy or Pharmacy Competencies Innovation & Creativity Result Orientation Collaboration Customer Centricity Developing Talent Stakeholder Management Strategic Agility Process Excellence

Qualifications: M.Sc./ B.E - B.Tech (Chemical Engg.) •1 to 4 years of experience. •Experience in handling critical equipment like reactor, centrifuge, blender, sifter, multi-mill, etc. • • Job Responsibilities: Ensure that the products are manufactured as per the cGMP. Maintain documentation as per regulatory authorities requirements like change control, and deviations. Highlight technical problems and take corrective actions. •

Key Responsibilities: Conduct QA audits and prepare reports. Implement SOPs for QA testing. Coordinate with operations and production teams. Maintain records for compliance and certification. Requirements: Experience with QA tools, documentation, and standards (ISO/GMP/etc.). Good analytical and observation skills. Familiarity with industry-specific QA processes.

Key Responsibilities: Develop and validate analytical methods using HPLC, UV, IR, and GC. Prepare protocols and reports for method development and validation. Perform stability studies and sample analysis for new products. Maintain instruments and lab notebooks as per SOPs and GMP guidelines. Coordinate with formulation development and QA teams. Requirements: M.Sc. / B.Pharm / M.Pharm in Chemistry/Pharmaceutical Sciences. Knowledge of ICH guidelines and regulatory documentation. Hands-on experience with chromatographic techniques and software. Analytical Method Development of Assay, Related Substances, Residual Solvents & Dissolution Test Methods with Literature Search & Report.

Responsible for maintaining and improving the Quality Management System (QMS) in compliance with ISO 13485:2016 and Local regulatory requirements (Indian Medical Device Rule). Responsible for internal audits, CAPA, change control, document control, risk management, and management review processes. Support external audits/inspections (Notified Body, regulatory, customer). Ensure compliance with applicable regulatory requirements and support quality system documentation updates. Collaborate with cross-functional teams to ensure quality and compliance across product lifecycle stages.

Inspect raw materials, in-process, and finished products. Perform quality tests and measurements. Record and report inspection results. Identify defects and coordinate corrective actions.