1742 Gmp Jobs - Page 2

Sun Pharmaceutical Industries Ltd. Position: Senior Officer Production Grade: G12B Location: API Dahej Location Taking charge from previous shift by checking BMR and status of plant/ batches for operation in shift. To ensure that status of other activity is as per log report while taking charge from Outgoing officer. During shift to ensure that GMP norms are strictly followed and to report superior in Case of any deviation understood. During shift ensure that follows process parameter as per BMR, if any deviation observed, than immediately corrective action 10 be taken and such deviation to be Documented and informed to reporting authority. Co-ordinate with service dept. like Eng. QC, store, etc. to ensure uninterrupted Services activate. Calibration and verification of weighing balance. Raw materials receipt from store by checking MRO and verifying with all containers of raw material dispensed to the batch numbers. Solid and process waste transfer to respective area and record maintaining. Other activities entrusted from time to time Differential pressure monitoring, Temperature or humidity, equipment occupancy Record. Housekeeping maintaining/ get cleaned by respective person.

Essential Functions: Strategic Leadership: Develop and implement international growth strategies aligned with organizational objectives. Identify and evaluate new market entry opportunities across target geographies. Spearhead expansion through partnerships, joint ventures, licensing, or acquisitions. Business Development: Drive B2B and B2C commercial strategies for product registrations and licensing. Forge and sustain relationships with international distributors, agents, and government stakeholders. Manage cross-border collaborations and strategic alliances. Sales & Marketing: Deliver sales and profitability targets in assigned international regions. Lead market-specific product launches and marketing initiatives, ensuring regulatory alignment. Analyze market intelligence and competitive activity to refine sales strategy. Regulatory & Compliance: Ensure product and market compliance with global regulatory standards (e.g., USFDA, EMA, WHO-GMP). Coordinate with regulatory teams for timely dossier submissions, approvals, and audits. Operations & Supply Chain: Collaborate with manufacturing, QA/QC, and supply chain to ensure timely and compliant product availability. Streamline logistics and distribution in accordance with international trade laws and customs regulations. Team Management: Lead, develop, and mentor regional business development teams and country managers. Create a results-driven, collaborative work culture that promotes high performance. Align regional sales operations with the overall business strategy and corporate goals. Additional Responsibilities: Represent the organization at international conferences and regulatory meetings. Provide timely updates to senior leadership on regional business performance. Contribute to pricing strategies and long-term business planning.

Equipment Knowledge of Plant area i.e. Reactor, Centrifuge, Dryer, Sparkler & Sifter etc. Knowledge of documentation as required in GMP like BMR, ECR, Usage Log Book etc Handling of Workmen in Plant area Knowledge for using of Safety Equipments which are using in Plant area Experience of general Computer knowledge.

Job Title: Cyber Security Specialist Location: Ambernath, India Job Type: Full-Time Reporting : CISO, Global IT Governance About Polypeptide Group: PolyPeptide Group AG and its consolidated subsidiaries ( PolyPeptide ) is a specialized Contract Development & Manufacturing Organization (CDMO) for peptide- and oligonucleotide-based active pharmaceutical ingredients. By supporting its customers mainly in pharma and biotech, it contributes to the health of millions of patients across the world. PolyPeptide serves a fast-growing market, offering products and services from pre-clinical to commercial stages. Its broad portfolio reflects the opportunities in drug therapies across areas and with a large exposure to metabolic diseases, including GLP-1. Dating back to 1952, PolyPeptide today runs a global network of six GMP-certified facilities in Europe, the U.S. and India. PolyPeptide s shares (SIX: PPGN) are listed on SIX Swiss Exchange. Position Overview: We are seeking a diligent and detail-oriented Cybersecurity specialist to join our cybersecurity team. This role is focused on executing vulnerability scans, analyzing results, and coordinating mitigation efforts to reduce risk across the organization. The candidate should be hands-on with tools like NMAP/ Zenmap and able to generate insightful visualizations and reports using Power BI . As the rest of the team is located in Europe (Sweden), flexibility in working times, and to be self-driven and efficient is highly rated. Key Responsibilities: Conduct regular vulnerability assessments using tools such as NMAP/ Zenmap to identify security weaknesses in systems and applications. Analyze scan results, assess risk severity, and escalate critical findings to appropriate stakeholders for timely action. Collaborate with IT and application teams to ensure effective remediation of identified vulnerabilities and verify implemented fixes. Track and document remediation progress, ensuring closure of findings and proper risk mitigation. Develop and maintain reports and dashboards (preferably using Power BI) to monitor vulnerability trends, risk exposure, and key performance indicators (KPIs). Continuously improve and standardize vulnerability management processes and workflows, ensuring alignment with industry standards. Stay updated on the latest security vulnerabilities, exploits, and remediation techniques, and apply threat intelligence to prioritize risks. Work in coordination with the Security Operations Center (SOC) to address vulnerabilities associated with active threats. Participate in patch management and configuration compliance cycles, following security benchmarks such as CIS, NIST, or ISO 27001. Maintain an accurate and up-to-date asset inventory, ensuring comprehensive coverage in scanning and remediation activities. Contribute to the development of security awareness materials, particularly focused on vulnerability risks and secure practices. Create and maintain relevant documentation, SOPs, and playbooks for vulnerability scanning, triage, and response procedures. Support third-party risk assessments by evaluating external vendors vulnerability exposure and security posture. Participate in red/blue team exercises and tabletop simulations to evaluate and improve vulnerability response readiness. Assist during audits and assessments, with occasional travel as required. Be available to contribute during U.S. operational hours at regular intervals , supporting cross-time-zone collaboration and incident response as needed. Qualifications & Requirements: Bachelor s degree in Cybersecurity, Computer Science, or related field (or equivalent hands-on experience). 2 3+ years of experience in vulnerability management, security operations, or related fields. Strong hands-on experience with NMAP/ Zenmap for scanning and analysis. Familiarity with vulnerability scoring systems like CVSS . Working knowledge of vulnerability management lifecycle and remediation workflows. Experience generating actionable reports and insights; Power BI experience is a plus . Strong analytical and communication skills. Strong skills in writing and speaking English Preferred Qualifications: Certifications such as CompTIA Security+, CEH, or equivalent are desirable. Experience with additional scanning tools (e.g., Nessus, Qualys) is a plus. Familiarity with security standards and frameworks (e.g., ISO 27001, NIST); NIS2 knowledge is a plus . Why Join Us at Polypeptide Group: Polypeptide Group offers an exciting opportunity to work at the forefront of peptide-based therapeutics, a rapidly growing and innovative segment of the pharmaceutical industry. As a key member of our Global IT Cyber Security and IT Compliance, you will have the opportunity to contribute to a company that is dedicated to the success of its clients and the advancement of peptide science. Join us and be part of a global organization that is shaping the future of life-saving therapies. ",

PolyPeptide is on a transformative growth journey expanding globally, investing in new technologies, and increasing our production capacity through major site expansions and strategic projects. As part of this journey, we are launching a global SAP S/4HANA implementation in a greenfield setup, building a brand-new ERP foundation from the ground up. This is a rare opportunity to join at the very beginning and help define how systems, data, and processes are connected across our global business over the coming years. As ERP Solution Architect, you will be at the very center of this transformation shaping our digital core and enterprise architecture from day one. You will play a strategic and hands-on role in designing an ERP landscape that supports operational excellence today and enables future innovation across the organization. A bout us PolyPeptide Group AG and its consolidated subsidiaries ( PolyPeptide ) is a specialized Contract Development & Manufacturing Organization (CDMO) for peptide- and oligonucleotide-based active pharmaceutical ingredients. By supporting its customers mainly in pharma and biotech, it contributes to the health of millions of patients across the world. PolyPeptide serves a fast-growing market, offering products and services from pre-clinical through to commercial stages. Its broad portfolio reflects the opportunities in drug therapies across areas and with a large exposure to metabolic diseases, including GLP-1. Dating back to 1952, PolyPeptide today runs a global network of six GMP-certified facilities in Europe, the U.S. and India. PolyPeptide s shares (SIX: PPGN) are listed on SIX Swiss Exchange. Our Values Trust: We build and maintain trust in all our relationships both with each other and with our customers. We support each other and work as a team. Innovation: We are curious and driven by finding smart solutions to the challenges we face. Excellence: We always strive to deliver high quality and adapt to meet the needs of our customers. About the Role As ERP Solution Architect, you will step into a strategic role at the very heart of our global ERP transformation. You will be responsible for defining and driving the overall SAP S/4HANA architecture from initial greenfield design to long-term evolution ensuring alignment across business domains and IT. You will work closely with business stakeholders, SAP consultants, and internal solution managers to translate business needs into integrated, scalable, and future-ready solutions that support our growth and regulatory requirements across all global sites. While this is not a hands-on configuration role, we are looking for someone with solid technical insight into SAP and a deep understanding of how to design and evaluate high-quality solutions including the ability to challenge and validate architectural decisions from implementation partners. Key Responsibilities In this role, you will: Serve as lead architect for the SAP S/4HANA greenfield implementation and future roadmap. Translate complex business requirements into robust end-to-end SAP solution designs (Order-to-Cash, Procure-to-Pay, Plan-to-Deliver, Record-to-Report, etc.). Validate and challenge architectural decisions from our SAP partners, ensuring alignment with industry standards, pharma regulations, and business needs. Define and maintain SAP architecture principles, governance frameworks, and integration strategies. Drive process harmonization, system integration, and data consistency across all business functions. Evaluate emerging SAP technologies (e.g., BTP, Cloud ALM) and advise on their adoption. Mentor SAP project teams and act as technical counterpart to Solution Managers. Your Profile To succeed in this role, we believe you bring: A degree in Computer Science, Information Systems, or similar. 10+ years of experience within SAP ERP architecture and implementation. Proven track record with SAP S/4HANA, ideally in greenfield implementations. Industry experience from CDMO/pharma or other regulated industries is a plus. Broad understanding of SAP modules and integration points. Knowledge of enterprise architecture frameworks and governance models. Strong communication and stakeholder management skills. A collaborative, proactive, and analytical mindset with the ability to bridge business and IT. Proficient in English, both speaking and writing. FIND THIS INTERESTINGAPPLY NOW! If you find this role interesting, don t miss this opportunity to bring your vision and experience to a forward-thinking organization. The position will be open until August 17th, 2025, but we are applying ongoing selection so do not hesitate to send us your application. Our Global IS/IT team is primarily based in Malm , but we also welcome applicants located near our other sites in Strasbourg, Braine, or Ambernath, provided you are within commuting distance. For . Swedish applicants are welcome to contact the local union chairman for Akademikerf reningen or Unionen at +46 040-36 62 00 for support. ",

About Apotex Inc. Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions. For more information visit: www.apotex.com . Job Summary Storage and Dispensing of Packaging Materials. Job Responsibilities Supervise the PM sampling activities at LVMP as per the plan and arrange the material for Sampling. Dispensing of Packaging materials as per LVMP production plan as per standard operating procedure. Ensure the storage of packaging materials as per cGMP. Ensure the online documentation related to LVMP packaging material warehouse on daily basis. Phisical stock verification (Cycle counting) and update the stock in SAP. Maintain safety and good housekeeping practices at work place. Ensure the cleaning activities in working area / equipment and updated the logbboks online. Store in and Store out of materials in ASRS WMS system. Calibration of Roll Label Counting Machine as per standard operating procedure. Daily monitoring and recording of Temperature / relative humidity in working area. Performing calibration activity of weighing balance (daily and Fortnightly). To maintain the online documentation related to Warehouse activities on daily basis. Works in a safe mannar collaborating as a team member to achive all outcomes. Demonstrate behaviours thst exhibit our organizational Values: Collaboration, Courage, Perseverance and Passion. Continuous Up gradation of knowledge with respect to cGMP and regulatory guidelines. Performance all work in support of our Corporate Values of Collaboration, Courage, Perseverance and passion. Demonstrates strong and visible support of our values. Ensure personal adherence with all complaines programs including the Global Business Ethicsand compliance program, Global quality policies and procedures, Safety and Environment policies and HR policies. All other relevant duties as assigned. Job Requirements Education B.Com Knowledge, Skills and Abilities:- Good knowledge in MS office, SAP and ASRS Operations. Maintains good Interpersonal skills and communication skills. Flexible to work. Experience:- 11+years of experience in GMP regulatory industry. At Apotex, we are committed to fostering a welcoming and accessible work environment, where all everyone feels valued, respected, and supported to succeed. We offer accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.

About Apotex Inc. Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions. For more information visit: www.apotex.com . Job Summary Under the guidance of Manager-Instrumentation / R&D , responsible for installation, maintenance and calibration of all the instruments in Apotex Research Pvt Ltd as per GMP/GLP requirements. Also responsible to generate and maintain laboratory equipment documentation. Job Responsibilities Conducts duties following established Apotex Research Pvt. Ltd., Standard Operating Procedures and in a consistent manner consistent with current regulatory (GMP, DCGI- CDSCO,TPD, USFDA, TGA, ICH, GLP, EMEA) guidelines / established practices / expectations. Perform maintenance and calibration of analytical instruments like HPLCs, GCs, pipettes, balances, etc and maintain instruments in good working order. Monitor and support during instruments installations and qualifications. Prepare and revise instrument related SOPs. Assists and involve in preparation and execution of documents for software validations. Maintain/Oversee all the instrument related qualification files, software validation reports, routine calibration records their scheduled archiving. Arrange vendor engineers for maintenance/calibration and maintain necessary AMC contracts with vendors. Update and maintain the Master list of instruments and calibration schedules. Monitor freezer/environmental monitoring system and respond to the alarms. Documents all the work and results of all assignments as required. Investigates and corrects analytical, instrumental, and procedural problems, if necessary in consultation with supervisor or management. Ensures that all work is performed in compliance with all pertinent SOP, GLPs, GALP and Safe Work Practices. Works in a safe manner collaborating as a team member to achieve all outcomes. Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion. Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies. All other relevant duties as assigned. Job Requirements Minimum BE / B.Tech / M.Sc. Instrumentation. 2 to 4 years of experience in Instrumentation of AR&D, Bioanlaytical lab, QC labs. Experience with analytical laboratory equipment like HPLC, LC/MS/MS, GCs etc. for trouble shooting, repairs, calibraitons, qualifications, etc. Fundamental understanding of concepts of GMP, GLP, GCP, 21 CFR Part 11guidelines. Computer skills in laboratory data acquisition software(s), spreadsheets and word processing. At Apotex, we are committed to fostering a welcoming and accessible work environment, where all everyone feels valued, respected, and supported to succeed. We offer accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.

Essential Functions: Operate and monitor equipment used in various stages of API production such as reactors, centrifuges, dryers, millers, sifters, etc. Ensure cleanliness and readiness of equipment before batch charging through visual verification procedures. Maintain accurate records, including Batch Manufacturing Record (BMR), Batch Cleaning Record (BCR), Batch Packing Record (BPR), equipment usage logs, and deviation reports. Execute batch operations strictly as per SOPs and GMP guidelines. Monitor and record process parameters in real-time to ensure adherence to specifications and quality. Report and coordinate with Engineering for any equipment breakdowns during the shift. Coordinate with QA for issuance and submission of documents and with the warehouse for material movement. Handle raw materials, intermediates, and APIs, ensuring proper storage, reconciliation, and documentation. Follow standard procedures for sampling and in-process testing of materials and intermediates. Maintain cleanliness and good housekeeping in the designated manufacturing area. Monitor utilities in the plant (e.g., steam, vacuum, chilled water) and report abnormalities. Monitor and record environmental conditions like temperature, humidity, and differential pressure in clean areas (Level-I, II, III). Perform daily verification and calibration checks of weighing balances. Participate in periodic equipment cleaning and preventive maintenance. Ensure proper handling and disposal of hazardous materials as per environmental guidelines. Identify process deviations, malfunctions, or quality concerns and report them immediately. Support continual improvement by suggesting ideas for optimization, efficiency, and waste reduction. Take mandatory safety and operational training via AIMS software and participate in hands-on skill-building sessions. Adhere strictly to safety practices and use PPE as per company safety protocols. Participate in emergency response activities such as managing spills or operational incidents. Ensure timely inventory of plant/process-related consumables. Review completed manufacturing records for accuracy, completeness, and compliance with SOPs. Additional Responsibilities: Support implementation of process improvement initiatives and lean manufacturing practices. Assist in the qualification and validation of equipment and processes as per regulatory and internal guidelines. Ensure readiness of the area for internal, external, and regulatory audits. Support investigation and documentation of deviations, change controls, and CAPAs in coordination with QA. Participate in cross-functional meetings to discuss production schedules, quality concerns, and improvement plans. Maintain discipline and GMP compliance on the shop floor and promote a culture of accountability. Train and mentor junior staff/operators on standard procedures and safe working practices. Assist in preparation and review of SOPs related to manufacturing activities. Support periodic review of equipment performance and suggest improvements for efficiency. Ensure adherence to environmental and safety norms in chemical handling and waste disposal. Actively participate in safety drills, risk assessments (HIRA), and incident investigations. Coordinate with stores for timely availability of raw materials, consumables, and packing materials. Report daily production updates to the shift in-charge or supervisor as required. Qualifications :- Education: Master Degree, M. Sc Organic Chemistry - Preferred Bachelor Degree, B. Pharma Preferred B.E. Chemical Required B. Tech Chemical Required Experience: 4 to 6 years in API/Intermediate manufacturing operations Skills: API Manufacturing Operations Intermediate to Advanced Batch Documentation (BMR/BCR/BPR) Intermediate GMP Compliance and Data Integrity Intermediate Process Monitoring and Troubleshooting Intermediate SOP Adherence and Equipment Operation Intermediate Safety and Emergency Response Intermediate Material Handling & Inventory Control Basic to Intermediate Utilities & Cleanroom Parameter Monitoring Basic Team Coordination and Communication Intermediate.

Primary Function/Primary Goals/Objective Ensure Food Safety Plan is implemented as per Abbotts Internal Policies & External Requirements, (such as FSSC22000 & Extenal Regulatory Bodies). Changes in Products, Production Processes, Equipments, Facilities etc are evaluated from Food Safety Risk Assessment with Mitigation Plans till Execution. Provide oversight to Plant GMP, Cleaning & Sanitation, Validation & CAPA Activities linked with Food Safety Support cascade of Global Food Safety Initiatives at Shop Floor Level. This list of responsibilities may change depending on plant needs and employees are expected to be adaptable and flexible where this need arises. Major Responsibilities: The role of Food Safety Engineer is part of the sites success and compliance by: Review & Improve Site Food Safety Plan through End to End Implementation of HACCP Principles into daily ways of working Promote Food Safety Culture & Vital Behaviours. Use Existing Databases to Track & Trend Data Points from Multiple Workstream to derive meaningful inferences & future improvement projects for Food Safety Improvements Lead/ Support Food Safety Risk Assessment with Mitigation Proposals linked with Change Management Cycle of RM/PM, Product, Process, Equipment, Facilities & Capital Projects. Lead/ Support Food Safety Event Investigation & Implementation of linked CAPAs with focus on systems & still remain reliable during manual operation. Participate in Abbotts Validation Review Board Meeting as well as CAPA Review Board Meetings for Proactive & Reactive Food Safety Risk Management. Active contribution to implementation of Global Food Safety Initiatives Provide oversight to Sites Cleaning, Sanitation & Hygiene Management Program Active coordination between Production, QA & Engineering Function for effective implementation of GMP, EMP & Sanitation Management Provide Periodic Refresher Trainings to Site Staff & Cascade Learnings from Global Food Safety Events from time to time. Liase with Global Subject Matter Experts from time to time to align improvement initiatives. Support Internal & External Food Safety Audits as per assigned responsibilities. Systematic Documentation linked with Quality System Compliances Provide Food Safety related Inputs to Leadership through Management Reviews/ other defined Mechanisms. Education: Minimum Bachelors Degree in Food Technology/ Daity Technology/ Food Engineering/ Microbiology/ Pharma with relavant experience in Plant Quality/ Food Safety/ GMP/ Hygiene & Sanitation. Experience of 7 to 10 years in Dairy/ Food/ Nutritional Powder Manufacturing Facility with emphasis on Infant Powder is preferred. Background Understanding and application of HACCP Principles with in depth understanding of Physical, Chemical & Microbiological Hazards with focus on food borne pathogen knowledge. Cleaning & Sanitation principles including Mode of Actions of chemicals Integrated Pest Control & Management Critical & Strategic thinking in order to go in depth understanding of Site Operations and related complex issues and provide the best feasible solutions at all levels. Communication, Collaboration & Influencing Skills Interpersonal skills in order to have healthy relationship with colleagues working in different functions at site Continuous Improvement Mindset Project Management Skills. Accountability/Scope: Keep Sites Food Safety Management System Live & Breathing with Continuous Improvement Food Safety Risks are proactively identified & appropriately mitigated. Learnings are built effectively in system to avoid repeat incidents. JOB FAMILY: Operations Quality DIVISION: ANSC Nutrition Supply Chain LOCATION: India > Jhagadia : Operation Support TRAVEL: Yes, 25 % of the Time t SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

Role & Responsibilities: To carryout the processes of different products as per the respective approved BMR from Q.A. To make entry in BMR while the process is in progress. To follow written standard operating procedure while working in the plant. To follow instructions given by the Production Executive and other superiors related to Personnel safety, product safety, product quality and its yields. To follow instructions relating to cGMP, GDP, Personal hygiene and other documentations related to regulatory requirements. To ensure operational control, availability of BMR, raw materials, packing material as per requirement. To report any ill health, injury, unfitness regarding work to Production Executives. To ensure that proper dress code, work behavior, personnel hygiene is followed in plant as per SOP. To give training to sub-ordinates and take proper shift charge from reliever (production officer/executive.) To ensure batch processing is done strictly as per Batch Manufacturing record (BMR). To report any deviation occurred/odd observations in plant to the production Executive. To take all necessary safety precautions & to ensure all necessary personal protective Equipment is worn while working in the plant. To maintain equipments cleaning and good housekeeping in plant. Ensure that all work relevant to his area is carried out under his supervision in accordance with company procedures as regards Safety, Health and Environmental Protection. To co-ordinate with QC department for sampling/testing of in-process, equipments cleaning ,intermediate, finished products, purified water, Microbiological analysis Etc. To co-ordinate with Maintenance department regarding Utility, equipments cleaning, quarterly preventive maintenance, equipment/instrument calibration and major breakdowns. To fill and maintain daily documents in plant. To co-ordinate with QA department regarding issuance of documents like BMR, BCRs, SOPs Formats, Log-books, Intimations, Training sheet etc. Desired Candidate Profile: Qualification: B.sc /M.sc in Chemistry Experience: 01 to 05 Years of experience in API/Bulk Drug manufacturing. Job Location: Boisar( Tarapur)

Amneal Pharmaceuticals is looking for Officer, Quality Control to join our dynamic team and embark on a rewarding career journey Collaborate with cross-functional teams to achieve strategic outcomes Apply subject expertise to support operations, planning, and decision-making Utilize tools, analytics, or platforms relevant to the job domain Ensure compliance with policies while improving efficiency and outcomes

Role & responsibilities Experience in Validation. Qualification of analytical instrument. Review & approve the standard operating procedures. Review and approve the Specification and Standard testing procedures. Review and approve the Calibration record. Review and approve the working standard qualification record. Review and approve the volumetric solution preparation and standardization record. Perform the gap analysis and address the observation with effective CAPA. Handling OOS, OOT and OOC. Preparation of Audit compliance report and effective implementation of same. Handle the training in the QC Dept. To ensure GLP in QC Lab. To ensure GMP in QC Lab. To ensure the Safety in QC Lab.

Must have minimum 4 years experience in QMS activity Issuance and management of QMS Forms (e.g., CC, CAPA, Deviation, etc.) Participate in the evaluation and investigation of quality-related issues Coordinate with cross-functional teams (CFT) and relevant stakeholders for issue resolution Review and compile supporting documents for QMS processes Maintain and update QMS log registers Ensure proper documentation and records management of QMS activities Perform artwork review to ensure compliance with quality standards Job Location: Kadi, Gujarat ( Bus facilities are available) Note: Immediate joiners will be preferred first

Jindal Stainless Limited is looking for Associate - Quality to join our dynamic team and embark on a rewarding career journey Understand customer needs and requirements to develop effective quality control processes Devise and review specifications for products or processes Set requirements for raw material or intermediate products for suppliers and monitor their compliance Ensure adherence to health and safety guidelines as well as legal obligations Supervise inspectors, technicians and other staff and provide guidance and feedback Oversee all product development procedures to identify deviations from quality standards Inspect final output and compare properties to requirements Approve the right products or reject defectives Keep accurate documentation and perform statistical analysis Solicit feedback from customers to assess whether their requirements are met Submit detailed reports to appropriate executives Be on the lookout for opportunities for improvement and develop new efficient procedures

He should know computer good computer knowledge He should know and having expertise in Good Manufacturing Practices (Developing, implementing. Required Candidate profile And maintaining quality systems and procedures ( Deviation/OOS investigation , batch card /SOP drafting ) that align with regulatory requirements.

Role & responsibilities Responsible for formulation and process development (QbD approach) of following categories of Pharmaceutical products: Oral Immediate-Release Dosage Forms. Oral Modified-Release Dosage Forms Including Pelletization technology and Wurster technology. Topical Semisolids (Creams, Ointment and Gels). Oral Liquid Dosage Forms Topical Liquid Dosage forms. Solid (Suppositories), Semisolid & Liquid dosage forms for Rectal and Vaginal applications. Design and execute formulation trials and evaluate stability data to finalize formulation composition. Execution of technology transfer batches for manufacturing processes from laboratory scale to production scale. Oral Immediate-Release Dosage Forms. Oral Modified-Release Dosage Forms Including Pelletization technology and Wurster technology. Topical Semisolids (Creams, Ointment and Gels). Oral Liquid Dosage Forms Topical Liquid Dosage forms. Solid (Suppositories), Semisolid & Liquid dosage forms for Rectal and Vaginal applications. Knowledge of patent non infringing strategy based product development Knowledge of Bioequivalence study & clinical study protocol and criteria Independent contributor for batch planning, batch execution & technology transfer Develop manufacturing processes for R&D formulations so that the technical transfer is successful for large-scale batches. Responsible for all formulation/ process related CMC documents which will be part of regulatory filings. Write/review master formulas, manufacturing procedures, SOPs, stability protocols, process validation protocols, Product Development Reports etc. Prepare/review specifications for pharmaceutical products and packaging components, etc. Support the manufacturing of exhibit/submission batches per regulatory requirements. Work with Cross-functional teams (Analytical, Regulatory Affairs, Pharmacovigilance, Bioequivalence, Quality Control, Quality Assurance, Inventory Control, etc.) to expedite the development and approval of new products by different Agencies for Regulated and ROW Markets. Assure that all formulation and process development activities are documented in the notebook as per company procedures and cGLPs. Provide recommendations for continuous improvements in practices and systems to improve performance and enhance efficiency and quality. Communicate with outside vendors and laboratories. Preferred Skill Set: Thorough knowledge of the pharmaceutical industry, particularly drug delivery industry, and formulation and process development including guidelines. Knowledge for development of formulations comes under category of medical devices, Dietary Supplements and Cosmetics. Knowledge of ICH/GMP regulations. Behavioral /Managerial Skill Sets Skills building and maintaining productive relationships with organizational partners including teamwork. Skills related to develop and deliver products well with in specified timelines. Being a team player Appropriate communication with all stakeholders

Interview for Production Dept on 02-08 in Bharuch for API Pharma Company in Dahej Qualification: BE / Diploma Chemical / BSC / MSC Chemistry / ITI AOCP Experience: 3 to 13 Years CTC: Up to 8 LPA No Charges Free Jobs Share with Your Friends!!! Required Candidate profile Send CV on sdpbharuch@gmail.com with Subject: Production Dahej & Call on 760033423 Interview Venue: SDP HR SOLUTION, Sixth Floor, 611, Golden Square, Beside DMART, Near ABC Circle, Bholav, Bharuch

Seeking a CSV Consultant to work on a variety of validation projects including manufacturing systems, lab systems, risk assessments, etc. Some of the work may be done remotely, some at client sites and others at one of our offices. Immediate start date Job Responsibilities: Responsible for the Computer System Validation processes of the company Maintain expertise in current and emerging cGMP requirements and quality trends (e.g., 210, 211, 820, and 21 CFR Part 11) Work independently on and successfully solve problems and complete/qualify a system within given constraint of scope, time and schedule Lead system qualification efforts and be the primary client contact for coordinating work, reporting status, resolving issues, and addressing change orders as they apply Minimum Requirements: Minimum degree requirement - Bachelor's degree with at least 10+ years of experience Must be willing to travel regionally and/or nationally throughout India Candidates must have excellent verbal communication and technical writing skills Experience in generation and execution of protocols and procedures related to different areas of qualification and validation Expertise in ISPE GAMP5, ICH Q8, ICH Q9, ICH Q10, 21 CFR Part 11, Computerized System Validation, Equipment Qualification, and Validation Change Control Working knowledge of protocol development for validation of complex computer systems (e.g., multiple GAMP classes of systems); ability to develop Installation, Operational, and Performance Qualification documents Experience in execution of system validation lifecycle deliverables Experience in project execution within at least one area of systems validation (e.g., laboratory equipment, facilities utilities, manufacturing equipment) Proficient in Microsoft Word, Excel, Power Point, and Project Ability to plan and manage own work All candidates must be legally eligible to work in India

Role & responsibilities -To perform the manufacturing process of products and to fill all the quality records in shift as per GMP. (BMR/BPR/ECR/Log Books/etc.) Following the SOP. -To give the requisition for Raw material/Packing material to Raw material store and verification of the same after receipt. -To give requisition for any consumable items to engineering store and verification of the same after receipt. -To give requisition for forms / formats and other quality related documents to QA and submission of the same to QA. -To make sure that all production deviations, non-conformance & accidents are reported along with investigation report. - To schedule training of plant personnel on SOPs, documentation and other cGMP compliances as per ICH Q7 and safety.

Long Description The person should have knowledge in Manufacturing equipments. He should have exposure in equipment’s such as FBE,Fette/KORSCH M/C & auto coater M/C. He should be able to handle equipment trouble shoot in Manufacturing department. He should have exposure in regulatory organization . He must have faced the USFDA ,MHRA & other regulatory audits. He should have the exposure in Caliber QAMS, elog, track wise ,SAP ,WIND ,CDAS & other software. He should have the exposure in process simplification/optimization ,SABA ,elog & SCADA. Competencies Education Graduation in Pharmacy Work Experience 3-6 years of experience in Fette compression machine

Job description Positition- Quality Manager Industry - FMCG Food Experience - 8+ years Location - Ghaziabad Work Summary - The job includes overall product quality, plant quality & packaging quality responsibilities. Ensuring RM, In-process and Finished goods product quality and safety. Including managing and training of QA/QC team to ensure ISO, 3P, FSSAI and other regulatory specifications. Key Role & Responsibilities: 1. Quality Management System (QMS): Oversee and maintain the QMS, ensuring compliance with all quality standards, including ISO, HACCP, GMP, and other industry-specific regulations. 2. Process Monitoring: Monitor all stages of the snacks production process to identify potential quality issues. Implement corrective actions promptly to mitigate any deviations from quality standards. 3. Product Testing and Analysis: Supervise laboratory staff in conducting tests on raw materials, in-process products, and finished product to ensure they meet nutritional, physical, and microbiological standards. 4. Supplier Quality Assurance: Collaborate with the procurement team to audit and evaluate suppliers, ensuring the quality of raw materials aligns with company standards. 5. Documentation and Reporting: Maintain accurate records of quality checks, audits, and corrective actions. Generate reports and present findings to management, providing insights into quality performance. 6. Continuous Improvement: Identify areas for improvement within the production and quality processes. Develop and implement strategies to optimize quality standards and reduce wastage. 7. Training and Development: Train and supervise quality assurance staff, ensuring they are skilled in the latest testing methods and quality control techniques. 8. Compliance and Audits: Prepare for and lead external and internal audits. Ensure all procedures are aligned with regulatory and industry requirements. 9. Customer Complaints and Feedback: Investigate quality-related customer complaints and implement corrective actions. Provide feedback to teams to prevent future issues. Desired Candidate (Professional/ Technical Competencies)- 1. Basic reading, writing 2. Knowledge of food manufacturing operations 3. Knowledge of food technology, food microbiology, safe food handling procedures and food sanitation practices. 4. Knowledge of Good Manufacturing Practices (GMP), HACCP Principles, ISO 9000, FSSC 22000 & other regulations 5. Ability to design and conduct Quality and Food Safety Audits. 6. Ability to apply sound technical principles to root cause analyses, problem- solving and project management. 7. Familiarity with product regulations, food safety, product labelling and nutrition science including FSSAI. 8. Must possess the ability to coordinate and plan strategically. 9. Success Framework Technical Competencies Food Safety, Food Safety & Quality Management System, Business Knowledge, People Management & Development, Problem Solving, Quality Delivery

Ensure current versions of all GMP documents are in use. Prepare, revise, and control SOPs . Implement and enforce (GDP). Conduct internal audits, maintain summaries and CAPA tracking Support in process validation, equipment qualification etc Required Candidate profile Ensure all QA activities comply with cGMP, regulatory requirements & internal quality standards for API & Specialty manufacturing. Contact Mr Deep at 9867038868, Email Id: ops@empowerrecruitments.com

Role & responsibilities Monitoring and data verification for all products and processes Monitor plant activity to ensure compliance to GMPs Maintains QC/QA documents (policies, procedures and records) as required; promote and enforce associate quality and food safety standards Maintain Food Safety and Quality Programs including SQF, allergens, SOPs and other prerequisite programs Conduct random internal inspections. interaction with regulatory and external auditors which can include accompanying the auditor and corrective action plan follow up interaction with plant management which includes assisting departments in researching quality-related issues act as QA department point of contact in the absence of the QA manager monitor and verify QA department responsibilities (inspecting incoming and finish products to ensure conformance to companys standards) Monitor pest control program. Conduct recalls\mock recall. Conduct daily water testing. effectively communicate food safety and quality programs using job instruction training techniques to QA as well as other department associates as needed being an on the work floor participant with production associates (when necessary) maintain Good Manufacturing Practices within the facility other duties as assigned Preferred candidate profile Experience in bakery industry. B.tech. With Food Technology.

B.Sc./M.Sc. with 1–4 years in QC (API). Hands-on with HPLC, GC, UV, and wet analysis. Experienced in raw material, in-process, and finished product testing. Strong in GMP, documentation, and analytical techniques. Required Candidate profile B.Sc./M.Sc. with 1–4 years’ QC experience in API. Proficient in HPLC, GC, wet lab testing, and GMP documentation. Detail-oriented, accurate, and skilled in analytical methods. Perks and benefits GMP GLP plant| Growth| Safety| Compliance| Perks

B.Sc/M.Sc. with 1–4 years in QA (API preferred). Strong in GMP, documentation, audits, and QMS. Detail-oriented, compliant, and reliable. Ready to ensure quality excellence in a world-class pharma environment. Required Candidate profile B.Sc/M.Sc. with 1–4 years’ QA experience in API. Skilled in GMP, documentation, audits, and QMS. Detail-oriented, disciplined, and committed to quality compliance. Perks and benefits GMP GLP plant |Growth |Safety |Compliance |Perks