1734 Gmp Jobs

The Quality & Compliance Specialist (QA) position at Piramal Pharma Solutions HPAPI Research and Manufacturing facility in Riverview, Michigan requires a dedicated individual to join the Quality Assurance (QA) team. The primary focus of this role is to support the manufacturing operations of the 24x7 facility while ensuring compliance with regulatory standards set forth by the United States Food and Drug Administration (USFDA) and other international authorities. The successful candidate will be responsible for implementing, executing, and maintaining Quality Systems related to manufacturing processes at the PPS-Riverview site. Key responsibilities of the Quality & Compliance Specialist include reviewing batch production records to ensure compliance with Good Manufacturing Process (GMP) requirements, supporting operations by promoting adherence to Good Manufacturing Practices, and carrying out administrative duties such as issuing master production records and maintaining document tracking systems. The Specialist will also be involved in conducting audits, preparing reports, and participating in Quality Systems Metric Reporting and analysis. To qualify for this position, candidates must possess a Bachelor's degree in physical or biological sciences/engineering with at least 1 year of experience in pharmaceutical operations/quality or a related field. Alternatively, an Associates degree with 2 or more years of relevant experience will be considered. Strong knowledge of GMP requirements, proficiency in MS Office, and experience with document management systems are essential for this role. Additionally, excellent organizational, communication, and analytical skills are required to succeed in this position. The successful candidate must be willing to work on a shift-based schedule, including weekends and holidays as needed. The induction period for this role is 3 months, with an expected time to reach performance effectiveness within 6 months. As part of the job conditions, individuals in this role may be exposed to hazardous chemicals and will be required to wear appropriate personal protective equipment. If you are a detail-oriented individual with a strong background in quality assurance and compliance, this role offers an opportunity to contribute to the success of the pharmaceutical manufacturing operations at Piramal Pharma Solutions in Riverview, Michigan.,

The job involves ensuring microbiological work in compliance with GLP and Regulatory lab standards. This includes tasks such as media preparation, GPT Test, Bioburden Test, MLT, Microbial Assay, Efficacy Test, AMV Test, Sterility Test, Bacterial Endotoxin Test (BET), Environmental Monitoring test, Swab Analysis, Culture and Maintenance, GPT Record, Pathogen Analysis, Grams Staining technique, and calibration of all instruments related to the Micro Lab. Additionally, the role requires QC labeling of all documentation related to the Microbiology Lab according to GLP, GMP, WHO & EU GMP guidelines. The position is full-time and permanent, with benefits including Provident Fund. The work schedule involves day and morning shifts, and the ideal candidate should have a total of 5 years of work experience. The work location is in person.,

As a Maintenance Executive for the Ice Cream plant at Heritage Foods in Hyderabad, you will play a crucial role in ensuring the smooth operation of our fully automated Ice Cream facility. You will be responsible for overseeing preventive maintenance operations for plant machinery and equipment, including Extruder line, Cone, Bulk filling and processing equipment from leading OEMs. Your primary goal will be to prevent any disruptions in the day-to-day functions of the Ice Cream Unit. To excel in this role, you should have a solid understanding of automated packaging and production lines. Experience with refrigeration systems, such as ammonia compressors, pasteurizers, and homogenizers, will be essential. Proficiency in handling PLC, SCADA, and automation systems is crucial, along with a good grasp of GMP and HACCP compliance standards. You should also be adept at troubleshooting electrical, mechanical, and refrigeration equipment to ensure uninterrupted operations. Additionally, knowledge of preventive and predictive maintenance strategies, energy efficiency initiatives, and sustainability practices will be advantageous. Familiarity with spare parts management and inventory control is also a plus. The ideal candidate will be between 28 to 35 years of age and willing to relocate to Hyderabad. Relevant experience in the Ice Cream industry is a must for this role. Join us at Heritage Foods as we strive to become one of the top Ice Cream brands in India. Your contribution will be vital in maintaining our tradition of delivering absolute richness in every bite of our delightful Ice Cream products.,

The job requires you to be responsible for ensuring product quality throughout the production process. You will be conducting inspections, identifying defects, and collaborating with production teams to implement necessary corrective actions. It will be your responsibility to maintain quality reports and ensure compliance with both company standards and customer requirements. Your key responsibilities will include inspecting raw materials, in-process, and finished products to guarantee quality standards are met. You will need to promptly identify and report any quality issues or non-conformities that may arise. Additionally, you will be expected to maintain accurate quality documentation and inspection reports. Collaboration with production and packaging teams will be essential to effectively resolve any defects that are identified. It will also be important for you to ensure that all quality and safety standards, such as ISO or GMP if applicable, are strictly adhered to. Moreover, you will be responsible for training workers on quality awareness and procedures. This is a full-time position that requires your physical presence at the work location.,

The QA Technical Senior Associate plays a crucial role in supporting Quality Assurance initiatives within the Quality Operations Network, focusing on Technical Writing, Document Management, and Business Performance. In this position, you will be responsible for executing key QA documentation processes, coordinating systems, and performing project-related administrative functions to ensure compliance with Quality Management System (QMS) requirements and enhance operational efficiency. Your role will involve working during regular business hours to assist Amgen in fulfilling its mission of serving patients, potentially leading a shift-based team that provides coverage across various time zones. You may be required to work outside standard hours to meet business needs and determine the same for your team. This position is based in our office in Hyderabad, India (Amgen India-AIN), and will involve leading remote support from AIN to Amgen sites globally. Your responsibilities will include: - Managing requests for site licenses and country-specific reports - Drafting and managing workflows for QA-owned procedures, including Standard Operating Procedures (SOPs) and Appendices - Conducting periodic document reviews and providing document system support using tools like DocuSign and Kneat - Creating and maintaining Smartsheet trackers and dashboards to support quality and business operations - Providing project coordination and administrative support for various activities, such as invoicing, expense reporting, audit logistics, and travel arrangements Preferred qualifications for this role include: - Experience in a GMP or regulated environment with exposure to quality documentation systems and tools - Strong attention to detail and demonstrated skills in document drafting and editing - Proficiency in document and project management systems like DocuSign, Kneat, and Smartsheet - Effective organizational and time management abilities to handle multiple priorities - Strong communication and interpersonal skills for cross-functional coordination - Ability to work independently within defined parameters and follow established procedures Key competencies for this position encompass: - Technical Writing and Document Control - System and Workflow Coordination - Business Operations and Project Support - Cross-Functional Communication and Collaboration - Organizational Agility - Detail-Oriented Execution Basic qualifications required for this role include a Masters degree with 5-9 years of experience in Pharma and Biotech commercial or clinical manufacturing Quality.,

The incumbent in this Engineering - API role is a team member of the Unit Engineering Maintenance & Reliability Team and is responsible for executing maintenance activities in the plant. They are accountable for ensuring minimum breakdowns in Instrumentation & Automation with maximum efficiency while adhering to safety & GMP standards. Additionally, they support the EM & R Senior Instrumentation Engineer in planning, scheduling, and executing CMP to ensure plant & equipment availability, capacity, integrity, and reliability in compliance with Cipla Policies, Standards & Procedures. As an Instrumentation Engineer in the Manufacturing & Packing Area, the individual executes maintenance tasks assigned by the Senior Engineer. In cases where maintenance is outsourced, the 3rd Party Instrumentation Engineer is responsible for the maintenance execution on the Service Floor / Technical Floor. The key responsibilities of this role are as follows: Shift Maintenance Activity: - Execute maintenance activities in a shift to achieve maintenance targets - Cater to machine maintenance requirements of the unit - Increase efficiency by reducing downtime and ensuring better equipment utilization - Prepare and submit shift engineer reports for smooth handover Comprehensive Maintenance Plan Execution: - Give inputs for preparing and adhere to a unique planner for planned preventive maintenance and instrument calibrations - Schedule shift activities in line with the CMP including PM, Calibration, and condition monitoring - Execute planned maintenance and update related documentation - Follow good Engineering practices during planned preventive activity Breakdown Maintenance: - Handle breakdown maintenance to avoid recurrence and maintain continuous process operations - Execute breakdown work safely and in compliance with cGMP - Maintain critical spares inventory to reduce resolution time Efficient Equipment Operation: - Operate equipment efficiently without error to meet shift targets - Maintain equipment, facility, and premises as per SOP for audit readiness - Ensure operations are performed as per GMP & Safety norms - Implement new technologies to improve machine/system performance Spares Management: - Perform Material and Spare management to avoid delays due to unavailability of materials - Issue required materials to contractors and make SAP entries - Maintain inventory of critical spares and consumables - Assess log book requirements and issue them within required timelines EHS Compliance: - Maintain high levels of Safety during maintenance - Monitor safe operations of the machine and report any safety deviations - Ensure compliance with safety systems and procedures - Issue work permits to contractual staff after verifying safety aspects cGMP Compliance: - Execute and update online documentation to meet cGMP requirements - Monitor cGMP compliance and report any incidents/deviations - Maintain online documentation and entries in all documents in a cGMP environment - Conduct training related to cGMP, equipment operation, safety, and housekeeping Continuous Improvements: - Provide suggestions for optimization of processes - Propose and implement new ideas to enhance production - Participate in internal audits to improve deficiencies Self Development: - Keep self-updated on regulatory guidelines and product regulatory requirements - Undergo training on Functional & Leadership capability building This role also involves interacting with internal stakeholders such as Central Engineering, EHS, Site head, Unit heads, Indirect purchase, Central purchase, Global Leadership Team, Corporate Affairs & Legal Team, as well as external stakeholders like OEMs, Facility maintenance contractors, Industry Bodies, and Statutory Bodies. The major challenges of this position include adherence to budget constraints, cost vs performance trade-off, aging assets leading to escalating OpEx costs, and challenges around personnel capability & competence. The educational qualification required for this role is BE/B Tech in Mechanical/Electrical/Instrumentation with 2-5 years of experience in manufacturing (Maintenance and Projects). The ideal candidate should possess good technical knowledge of Pharma/API machinery, experience in project execution, knowledge of GMP and regulatory requirements, as well as strong leadership skills and experience in industrial automation.,

As a Senior Officer Production at Sun Pharmaceutical Industries Ltd., located in API Dahej, your responsibilities will include taking charge from the previous shift by checking Batch Manufacturing Records (BMR) and the status of plant/batches for operation during your shift. It is essential to ensure that all activities are in line with the log report while taking charge from the outgoing officer. Throughout the shift, you must strictly adhere to Good Manufacturing Practices (GMP) norms and promptly report any deviations to your superior. In case of any observed deviations from the process parameters outlined in the BMR, immediate corrective actions should be taken, documented, and reported to the relevant authority. Your role will also involve coordinating with service departments such as Engineering, Quality Control, and Stores to guarantee uninterrupted services. Additionally, you will be responsible for the calibration and verification of weighing balances, as well as overseeing the receipt of raw materials from the store by cross-checking Material Requisition Orders (MRO) and verifying them with all containers of raw materials dispensed for batch numbers. Managing the transfer of solid and process waste to the respective area and maintaining records of such activities will be part of your routine tasks. Furthermore, you will be expected to monitor differential pressure, temperature, humidity, and equipment occupancy records. It is crucial to uphold proper housekeeping standards and ensure that the designated areas are cleaned by the respective personnel. Moreover, you may be assigned other activities as required from time to time, contributing to the efficient and compliant operation of the production facility at Sun Pharmaceutical Industries Ltd.,

Job Description Business: Piramal Critical Care Department: Regulatory Affairs Location: Kurla Travel: Low Job Overview The Manager, Regulatory Affairs is responsible for the portfolio of Piramal Critical Care Products in the USA market. They will be responsible for authoring and reviewing submissions for dissemination to Health Authorities, country distributors or external partners. Will work closely and train other junior regulatory staff. Key Stakeholders: Internal External partners, Country Distributors, Health Authorities Key Stakeholders: External Cross-Functional Teams Reporting Structure Reports to: Senior General Manager-Regulatory Affairs Direct Reports: Yes Essential Qualification & Experience Master&aposs in Pharmacy degree, full time (Regulatory Affairs certification is preferred) Minimum of 8 to 10 years of experience in a pharmaceutical regulatory affairs department. Experience in leading dossier submission to Latam/ ROW markets and post approval variations. Key Responsibilities Work closely with internal and external manufacturing sites to. assess post approval product chemistry, manufacturing and control (CMC) changes and determine appropriate global filing strategy Manage the assembly, compilation, submission and electronic publishing (if required) of documentation for product compliance, registration and life cycle maintenance. Support regulatory and broader development teams on strategic projects including gap analyses, meetings with regulatory authorities, product development and review, and other strategic deliverables. Evaluate business opportunities and perform regulatory due diligence for in licensing and product acquisition for assigned region. Maintain up-to-date knowledge of data requirements, applicable SOPs, policies, regulations, guidelines, and industry standards. Knowledge areas include ICH, WHO, GMP, USP, stability, validation, and US regulations. Review and interpret pertinent regulations and guidelines to develop proactive solutions to regulatory issues and challenges and communicate them to the other team members and functionalities within the organisation Competencies Exceptional communication, negotiation, presentation, and influencing skills across internal and external stakeholders Expert knowledge and proficiency at interpreting regulatory guidelines. Possess excellent abilities to draft the CMC section of dossier Strong analytical, conceptual, problem-solving, and decision-making abilities Effective collaboration skills Proactive, with a strong ability to learn and adapt Advanced skills in Microsoft Office Suite (Excel, Word, PowerPoint, and Access) Critical Thinking using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems Proficient in both verbal and written communication Ensuring the maintenance of confidentiality at all times Capable of presenting multiple solutions creatively Displaying enthusiasm and a positive attitude Excellent customer service skills and professional demeanor at all times to interface effectively with all internal and external customers About Us In the three decades of its existence, Piramal Group has pursued a twin strategy of both organic and inorganic growth. Driven by its core values, Piramal Group steadfastly pursues inclusive growth, while adhering to ethical and values-driven practices. Equal employment opportunity Piramal Group is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, ethnicity, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, genetics, or other applicable legally protected characteristics. We base our employment decisions on merit considering qualifications, skills, performance, and achievements. We endeavor to ensure that all applicants and employees receive equal opportunity in personnel matters, including recruitment, selection, training, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions, including reasonable accommodation for qualified individuals with disabilities as well as individuals with needs related to their religious observance or practice. About The Team Piramal Critical Care (PCC), under Piramal Pharma Limited (PPL), a subsidiary of Piramal Enterprises Limited, is the third largest producer of Inhaled Anaesthetics and a global player in hospital generics. Motivated by its vision to deliver critical care solutions for patients and healthcare providers across the globe, PCC is committed to enabling sustainable and profitable growth for all its stakeholders. PCC maintains a wide presence across the USA, Europe and more than 100 countries across the globe. Its rich product portfolio includes Inhalation Anaesthetics such as Sevoflurane, Isoflurane and Halothane as well as Intrathecal Baclofen therapy, for spasticity management. PCC has wholly-owned, state-of-the-art manufacturing facilities in the US and India that have successfully cleared periodical inspections by the US FDA, UK MHRA and other regulators. Its core strength lies in a highly qualified global workforce of more than 400 employees across 16 countries. PCC is focused on further expanding its global footprint through new product additions in the critical care space. Committed to corporate social responsibility alongside Piramal Group, PCC collaborates with various partner organizations and proudly takes an active role in providing hope and resources to those in need, as well as caring for the environment. Show more Show less

Be the First to Apply Job Description Business: PPL Digwal Department: Production Location: Digwal Job Overview: To perform Production actives as per GMP & Safety Travel Requirements : NA Reporting Structure Reports to Manager - Production Key Stakeholders Internal: QC, QA, SCM & Safety External: NA Experience 4-8 Year Experience in manufacturing (API) as per Pharma Manufacturing GMP requirements. Responsibilities Key Roles & Responsibilities Participate and adhere in all EHS continual improvement & line responsibilities (Eg. Emergency mock drill participation, training, permit to work, etc.) And responsibilities mentioned in the site EHS procedures. Follow all the site safety requirements and exhibit positive behavior in the safety culture transformation. Follow the all permit to work procedure in shop-floor activities. Follow the required Personnel Protective equipment (PPE) usages during performing the shop-floor operations. Identify the unsafe conditions / unsafe acts and report to Manager/EHS team and report any safety-related incidents, accidents, learning incidents or illnesses to the OHC / Superiors / Manager immediately. Follow the previous shifts information / Managers instructions and complete the assigned tasks, on time. Ensure that executed BMRs, BPRs, ECRs review timely and submit to QA, as soon as possible, based on the requirement. Review & update the shop-floor documents contemporaneously i.e. BMRs, BPRs, ECRs, Logbooks, Protocols, Reports, Checklists, etc. Update the shift logbook as per the process status as well as any priorities or instructions, and hand it to the reliever during the shift change. Impart the trainings on SOPs, revised documents & qualification protocols/ reports to shop-floor personnel. Strictly follow the SOPs on shop-floor. Ensure all the raw material as per RM indent and keep ready for the batches. Raise the work order for maintenance works & coordinate with E&M team for the completing tasks the in time. Co-ordinate with engineering department for performing the scheduled equipment Preventive Maintenance (PM) and instrument calibrations. Ensure batch execution in line with the production schedule. Ensure the cleanliness and good housekeeping in respective areas. Manpower planning to be done based on production priorities, in shifts. Participate in the trainings as per the schedule. In the absence of the Superior, responsible for his work. Qualifications Qualification : B.Sc (Chemistry) / M.Sc (Chemistry) / B.Tech (Chemical) About Us In the three decades of its existence, Piramal Group has pursued a twin strategy of both organic and inorganic growth. Driven by its core values, Piramal Group steadfastly pursues inclusive growth, while adhering to ethical and values-driven practices. Equal employment opportunity Piramal Group is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, ethnicity, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, genetics, or other applicable legally protected characteristics. We base our employment decisions on merit considering qualifications, skills, performance, and achievements. We endeavor to ensure that all applicants and employees receive equal opportunity in personnel matters, including recruitment, selection, training, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions, including reasonable accommodation for qualified individuals with disabilities as well as individuals with needs related to their religious observance or practice. About The Team Piramal Pharma Solutions (PPS) is a Contract Development and Manufacturing Organization (CDMO) offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our customers through a globally integrated network of facilities in North America, Europe, and Asia. This enables us to offer a comprehensive range of services including drug discovery solutions, process & pharmaceutical development services, clinical trial supplies, commercial supply of APIs, and finished dosage forms. We also offer specialized services such as the development and manufacture of highly potent APIs, antibody-drug conjugations, sterile fill/finish, peptide products & services, and potent solid oral drug products. PPS also offers development and manufacturing services for biologics including vaccines, gene therapies, and monoclonal antibodies, made possible through Piramal Pharma Limiteds investment in Yapan Bio Private Limited. Our track record as a trusted service provider with experience across varied technologies makes us a partner of choice for innovators and generic companies worldwide. Job Info Job Identification 9139 Job Category Production Posting Date 07/29/2025, 09:26 AM Apply Before 08/06/2025, 09:26 AM Degree Level Bachelor&aposs Degree Job Schedule Full time Locations Piramal Enterprises Limited. Factory: Digwal, Medak, Telangana, 502321, IN Show more Show less

Be the First to Apply Job Description Business: PPL Digwal Department: Production Location: Digwal Job Overview: To perform Production actives as per GMP & Safety Travel Requirements : NA Reporting Structure Reports to Manager - Production Key Stakeholders Internal: QC, QA, SCM & Safety External: NA Experience 4-8 Year Experience in manufacturing (API) as per Pharma Manufacturing GMP requirements. Responsibilities Key Roles & Responsibilities Participate and adhere in all EHS continual improvement & line responsibilities (Eg. Emergency mock drill participation, training, permit to work, etc.) And responsibilities mentioned in the site EHS procedures. Follow all the site safety requirements and exhibit positive behavior in the safety culture transformation. Follow the all permit to work procedure in shop-floor activities. Follow the required Personnel Protective equipment (PPE) usages during performing the shop-floor operations. Identify the unsafe conditions / unsafe acts and report to Manager/EHS team and report any safety-related incidents, accidents, learning incidents or illnesses to the OHC / Superiors / Manager immediately. Follow the previous shifts information / Managers instructions and complete the assigned tasks, on time. Ensure that executed BMRs, BPRs, ECRs review timely and submit to QA, as soon as possible, based on the requirement. Review & update the shop-floor documents contemporaneously i.e. BMRs, BPRs, ECRs, Logbooks, Protocols, Reports, Checklists, etc. Update the shift logbook as per the process status as well as any priorities or instructions, and hand it to the reliever during the shift change. Impart the trainings on SOPs, revised documents & qualification protocols/ reports to shop-floor personnel. Strictly follow the SOPs on shop-floor. Ensure all the raw material as per RM indent and keep ready for the batches. Raise the work order for maintenance works & coordinate with E&M team for the completing tasks the in time. Co-ordinate with engineering department for performing the scheduled equipment Preventive Maintenance (PM) and instrument calibrations. Ensure batch execution in line with the production schedule. Ensure the cleanliness and good housekeeping in respective areas. Manpower planning to be done based on production priorities, in shifts. Participate in the trainings as per the schedule. In the absence of the Superior, responsible for his work. Qualifications Qualification : B.Sc (Chemistry) / M.Sc (Chemistry) / B.Tech (Chemical) Job Info Job Identification 5304 Posting Date 07/29/2025, 06:28 AM Apply Before 08/04/2025, 06:28 AM Degree Level Technical Diploma/A Level Job Schedule Full time Locations Piramal Enterprises Limited. Factory: Digwal, Medak, Telangana, 502321, IN Show more Show less

Be the First to Apply Job Description Business: PPL Digwal Department: Production Location: Digwal Job Overview: To perform Production actives as per GMP & Safety Travel Requirements : NA Reporting Structure Reports to Manager - Production Key Stakeholders Internal: QC, QA, SCM & Safety External: NA Experience 4-8 Year Experience in manufacturing (API) as per Pharma Manufacturing GMP requirements. Responsibilities Key Roles & Responsibilities Participate and adhere in all EHS continual improvement & line responsibilities (Eg. Emergency mock drill participation, training, permit to work, etc.) And responsibilities mentioned in the site EHS procedures. Follow all the site safety requirements and exhibit positive behavior in the safety culture transformation. Follow the all permit to work procedure in shop-floor activities. Follow the required Personnel Protective equipment (PPE) usages during performing the shop-floor operations. Identify the unsafe conditions / unsafe acts and report to Manager/EHS team and report any safety-related incidents, accidents, learning incidents or illnesses to the OHC / Superiors / Manager immediately. Follow the previous shifts information / Managers instructions and complete the assigned tasks, on time. Ensure that executed BMRs, BPRs, ECRs review timely and submit to QA, as soon as possible, based on the requirement. Review & update the shop-floor documents contemporaneously i.e. BMRs, BPRs, ECRs, Logbooks, Protocols, Reports, Checklists, etc. Update the shift logbook as per the process status as well as any priorities or instructions, and hand it to the reliever during the shift change. Impart the trainings on SOPs, revised documents & qualification protocols/ reports to shop-floor personnel. Strictly follow the SOPs on shop-floor. Ensure all the raw material as per RM indent and keep ready for the batches. Raise the work order for maintenance works & coordinate with E&M team for the completing tasks the in time. Co-ordinate with engineering department for performing the scheduled equipment Preventive Maintenance (PM) and instrument calibrations. Ensure batch execution in line with the production schedule. Ensure the cleanliness and good housekeeping in respective areas. Manpower planning to be done based on production priorities, in shifts. Participate in the trainings as per the schedule. In the absence of the Superior, responsible for his work. Qualifications Qualification : B.Sc (Chemistry) / M.Sc (Chemistry) / B.Tech (Chemical) About Us In the three decades of its existence, Piramal Group has pursued a twin strategy of both organic and inorganic growth. Driven by its core values, Piramal Group steadfastly pursues inclusive growth, while adhering to ethical and values-driven practices. Equal employment opportunity Piramal Group is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, ethnicity, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, genetics, or other applicable legally protected characteristics. We base our employment decisions on merit considering qualifications, skills, performance, and achievements. We endeavor to ensure that all applicants and employees receive equal opportunity in personnel matters, including recruitment, selection, training, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions, including reasonable accommodation for qualified individuals with disabilities as well as individuals with needs related to their religious observance or practice. About The Team Piramal Pharma Solutions (PPS) is a Contract Development and Manufacturing Organization (CDMO) offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our customers through a globally integrated network of facilities in North America, Europe, and Asia. This enables us to offer a comprehensive range of services including drug discovery solutions, process & pharmaceutical development services, clinical trial supplies, commercial supply of APIs, and finished dosage forms. We also offer specialized services such as the development and manufacture of highly potent APIs, antibody-drug conjugations, sterile fill/finish, peptide products & services, and potent solid oral drug products. PPS also offers development and manufacturing services for biologics including vaccines, gene therapies, and monoclonal antibodies, made possible through Piramal Pharma Limiteds investment in Yapan Bio Private Limited. Our track record as a trusted service provider with experience across varied technologies makes us a partner of choice for innovators and generic companies worldwide. Job Info Job Identification 9138 Job Category Production Posting Date 07/29/2025, 09:15 AM Apply Before 08/06/2025, 09:15 AM Degree Level Bachelor&aposs Degree Job Schedule Full time Locations Piramal Enterprises Limited. Factory: Digwal, Medak, Telangana, 502321, IN Show more Show less

You have an opportunity as a Warehouse and Logistics Manager where you will be responsible for overseeing warehouse operations, inventory control, team management, safety compliance, and logistics and supply chain management in the pharmaceutical/API sector. Your key responsibilities include managing warehouse operations such as receipt, storage, and dispatch of materials, optimizing warehouse layout for efficiency, implementing inventory tracking systems, maintaining accurate inventory records, ensuring compliance with regulatory standards, and supervising warehouse staff. You will also be involved in coordinating with QA/QC for proper material handling, conducting training programs on safety protocols and material handling, implementing safety protocols to prevent workplace accidents, planning and optimizing logistics operations, ensuring on-time delivery of materials and products, managing transportation costs, negotiating contracts with logistics partners, and managing export/import documentation for international shipments. To excel in this role, you should possess strong knowledge of warehouse and logistics management in the pharmaceutical/API sector, familiarity with ERP/WMS software, expertise in compliance regulations such as GMP, GDP, FDA, experience in handling cold storage and hazardous materials, excellent leadership and team management skills, strong analytical and problem-solving abilities, and effective communication and coordination skills with internal and external stakeholders. For qualifications and experience, you should have a Bachelor's/Masters degree in Pharmacy, Supply Chain Management, Logistics, or a related field, a minimum of 7-10 years of experience in warehouse/logistics management, preferably in the pharmaceutical/API industry, and relevant certifications such as GMP/GDP certification or warehouse management certification would be a plus.,

You should have good knowledge of GMP/GDP documentation. It is essential to be proficient in coordination and maintain discipline. Possession of an Employment Exchange Card is mandatory. Preference will be given to Goan candidates. This is a full-time, permanent position with benefits including health insurance and Provident Fund. The job involves working in rotational shifts with shift allowance provided. A Bachelor's degree is preferred for this role. The work location is in Mapuca, Goa and the availability of working night shifts is required. The job requires in-person presence. The application deadline for this position is 30/04/2025, and the expected start date is 04/05/2025.,

We are looking for an Associate Officer - QC Injectable to join our Quality Control team located in Selaqui, Dehradun. As an ideal candidate, you should possess a solid background in Chemistry or a related field, coupled with practical experience in the quality control of injectable pharmaceutical products. Your primary responsibilities will include monitoring and inspecting the quality of injectable products manufactured by our company. It will be your duty to ensure that all products meet the required quality standards and adhere to regulatory guidelines. You must strictly adhere to established quality control processes and procedures, maintaining precise and current quality control records. Additionally, you will be expected to contribute to maintaining a safe, clean, and compliant work environment, and fulfill any other duties assigned by the QC Manager. To qualify for this position, you should hold a Bachelor's degree in Chemistry or a related discipline and have a minimum of 3 years of relevant experience in Quality Control, with a preference for experience in injectables. A strong understanding of quality control systems, Good Manufacturing Practices (GMP), and regulatory compliance is essential. The ability to work independently with minimal supervision, excellent communication, problem-solving, and organizational skills are crucial. You should also demonstrate the capability to thrive in a fast-paced, deadline-driven environment. If you meet these qualifications and are interested in joining our team, please share your resumes with us at hr@saifevetmed.com. For further inquiries or information, you can reach out to us at 8882860579.,

You are a skilled and responsible Operator who will be joining our Engineering Department at our Indore Plant. In this role, you will be responsible for operating, monitoring, and maintaining key engineering systems within our pharmaceutical manufacturing plant. These systems include Water Treatment Plants (WTP/RO/DM/WFI/PS), HVAC systems, Utilities, and Plant Maintenance (Mechanical/Electrical). Your key responsibilities will include operating and monitoring Water Treatment Plants as per SOPs, maintaining HVAC systems, performing routine checks on utility equipment, supporting mechanical or electrical maintenance activities, identifying and reporting equipment malfunctions, maintaining documentation as per GMP requirements, and assisting in maintenance activities. To qualify for this role, you should have a qualification of ITI/Diploma in Mechanical, Electrical, or a relevant trade, along with 15 years of experience in the pharmaceutical/chemical/process industry. Hands-on experience in Water systems, HVAC system operations, Utility operations, or mechanical/electrical plant maintenance is required. Knowledge of GMP, safety protocols, and basic engineering documentation is also essential. Desired attributes for this role include technical aptitude, problem-solving skills, good communication and team collaboration, willingness to work in shifts if applicable, and the ability to follow SOPs and regulatory standards. This is a full-time position with a rotational shift (if applicable) and the compensation will be as per company norms and experience.,

You will be part of a greenfield project located in GIDC Vapi, covering an area of 10,556 sq m dedicated to the manufacturing of Pharma Intermediates and APIs. The project is designed to include a main intermediate production building, a GMP facility, and infrastructure for Catalytic Hydrogenation, emphasizing sustainable practices and competitive innovation. Your responsibilities will involve the preparation and upkeep of Engineering/Project documentation, Qualification & Validation documents throughout the various stages of the greenfield project until commercial manufacturing. It is essential to ensure the implementation and adherence to industry/cGMP best practices. This includes creating Qualification documents such as URS, DQ, IQ, OQ & PQ for production and utility equipment, as well as overseeing Engineering documents encompassing certificates, calibration, test results, inspection requests, non-compliance reports, and other crucial QA/QC documents. You will be accountable for tasks like conducting factory acceptance tests at vendor sites, qualifying new equipment, and periodically re-qualifying equipment and facilities like PW plant HVAC. Additionally, you will be involved in the Preparation & Review of SOPs for the Engineering department, Training and Approval of Qualification SOPs, preparing Facility qualification documents, and developing Project-specific qualification plans for significant changes. Your role will also entail the creation of various documents such as Installation and operational qualification protocols and reports, Performance Qualification Protocols and reports, and conducting training sessions for new hires and Executives on Qualification Activities. To qualify for this role, you should hold a BE/ BTech degree in Chemical/Mechanical Engineering with a background of 5-10 years in Engineering/Project documentation. Strong written and verbal communication skills will be beneficial for effectively carrying out the responsibilities associated with this position.,

Company Name VM Bakery Products Pvt Ltd Job Title Production & Quality Internship Job Location: Vijayawada Description We are inviting passionate students to apply for stipend-based internships in Production and Quality Control at our bakery unit in Vijayawada. ???? Location: Vijayawada ???? Duration: 6 months to 1 year ???? Stipend: Based on performance and duration ???? Eligibility B.Tech / B.Sc / M.Sc Food Technology, Biotechnology, Microbiology Basic knowledge of GMP, FSSAI preferred No. of vacancy 08 Experience Freshers ???? Departments Production Mixing, Baking, and Packing Operations Quality QC/QA, Documentation, Food Safety ? ???? Key Learning Areas ? Production line operations ? Mixing, baking & packing flow ? Hygiene & food safety practices ? Quality testing & internal audits ? FSSAI, HACCP, GMP systems ? Documentation & traceability Apply Here [HIDDEN TEXT] Show more Show less

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.