118 Gmp Compliance Jobs

Responsibilities: * Manage production processes from BMR to dispatch. * Oversee liquid oral, syrup, ointment, GMP compliance, cream & manpower handling. * Ensure quality control measures are implemented.

As a Specialist in Manufacturing Automation, you will play a crucial role in our digital manufacturing team by serving as a technical control system subject matter expert for the enterprise managed DeltaV process control system. Your passion for enhancing operations efficiency, control system availability, robustness, and performance will drive your success in this position. Your responsibilities will include collaborating with both local and remote team members to upgrade and standardize DeltaV systems. You will develop strategies to optimize process automation systems, ensuring quality, stability, and future expansion. Additionally, you will be tasked with developing standards, processes, and tools for upgrading and patching operating systems, as well as monitoring DeltaV and other automation systems to maintain optimal performance. To excel in this role, you should possess a good understanding of process control systems architecture and administration. Your experience with Emerson DeltaV system standards, project execution, and common automation interface protocols will be essential. Effective communication skills and the ability to work independently on multiple projects are also key qualifications for this position. While not required, experience with GMP Quality Systems, IT systems integration, networking, and monitoring platforms would be advantageous. Familiarity with Agile project development practices and software tools such as Jira and Confluence is a plus. If you are looking for a challenging yet rewarding opportunity to contribute to the advancement of manufacturing automation, we encourage you to apply for this role and become part of our innovative team.,

Cyano Pharma Pvt Ltd is a leading pharmaceutical organization in INDORE (MP) focused on quality, compliance, and innovation. We are looking for a highly skilled professional with strong expertise in Quality Management Systems (QMS) and Validation & Qualifications to ensure compliance with international regulatory standards (WHO, USFDA, EMA, MHRA). Key Responsibilities: Quality Management System (QMS): - Implement, maintain, and continuously improve the site Quality Management System in line with global regulatory guidelines (WHO, USFDA, EMA, MHRA). - Prepare, review, and update SOPs, quality manuals, and quality policies. - Manage change control, deviation, incident reporting, and risk management systems. - Coordinate and support internal, external, and third-party audits, ensuring timely CAPA implementation and closure. - Monitor and analyze quality metrics to drive continuous improvement initiatives. - Provide training and awareness programs for QMS procedures and GMP compliance across teams. - Act as a key contact for regulatory inspections and customer audits. Validation & Qualifications: - Prepare and execute qualification protocols (IQ/OQ/PQ) for equipment, utilities, facilities, and systems. - Lead process validation, cleaning validation, and computer system validation as per regulatory requirements. - Develop and maintain the Validation Master Plan (VMP). - Ensure periodic requalification and revalidation activities are performed according to schedules. - Review and approve all validation-related documents, including protocols and reports. - Ensure all validation activities comply with cGMP, data integrity, and documentation requirements. - Work closely with cross-functional teams (engineering, production, QC) to ensure smooth validation and qualification processes. Qualifications & Experience: - M.Pharm with 9-10 years of experience in Quality Assurance within the pharmaceutical industry. - Strong hands-on experience in QMS implementation and validation/qualification activities. - In-depth knowledge of global regulatory requirements (WHO, USFDA, EMA, MHRA). - Strong communication, documentation, and audit-handling skills. - Proficiency in MS Office (Word, Excel, PowerPoint) and quality documentation systems. - Location: Indore Benefits: - Competitive salary and performance-based incentives. - Opportunity to work on global compliance and regulatory projects. - Exposure to international audits and career advancement opportunities.,

Roles and Responsibilities: Manage procurement activities for active pharmaceutical ingredients, engineering spares, project materials, stores material purchase, GMP compliance, vendor coordination, documentation, AMC handling. Ensure timely delivery of goods and services to meet production schedules. Develop strong relationships with vendors through effective communication and negotiation skills. Maintain accurate records of purchases and inventory levels using SAP systems. Collaborate with cross-functional teams to resolve issues related to supply chain management. Desired Candidate Profile: 3-5 years of experience in a similar role within the pharmaceutical industry. Bachelor's for Master degree in relevant field. Proficiency in SAP systems for procurement processes. Strong understanding of GMP regulations and their application in a manufacturing environment.

* personnel need to be aware of the quality policy, their contribution to the QMS, requirements and Responsibilities: * GMP documentation handling * Ensure compliance with regulatory requirements through audits and inspections.

Role & responsibilities : Assist Superiors in achieving the goals set. Follow the receipt procedures as mentioned in SOP for Receipt of materials and signing of weighments and check list Follow the issuance procedure as mentioned in the SOP for Issuance and signing of material. Ensure that the stock of materials is always available and stores off the floors on pallets with proper labeling and check for the compatibility and storage conditions. Preparation GRN's in SAP for all RM/PM receipts, Inform to QA/QC for Sampling of these materials and signing the Label , RM/PM Receipt Check list and Weighments. Entry and issue in SAP of all Raw Materials, Packing Materials, Intermediate and Finished Goods Stock, daily consumption, dispatch details and Monthly stock statements and signing the Issue Slip. Physical stock verification of the Inventory to be done. Properly maintaining the stocks in stock registers and signing in registers. Giving the acknowledgement for receipts of Raw material and Packing material. Filling up of all daily records like performance checking of balances, temperature monitoring in all RM stores, maintaining cleanliness and updating and signing the cleaning records. Assist superiors in Absence of other team members. Authorizing the Issue slips and issuance labels after issuance of material as per SOP. Informing superiors about any Deviations from the laid down procedures. Proper labeling of all materials in Stores Department. Entry in all RLAF Register after Dispensing activity is over as per SOP. Handling of rejected raw material & packing material activity. Preferred candidate profile: 2-4 years of experience in stores or related field in pharmaceutical industry. B.Com or M.Com degree from recognized university. Strong knowledge of active pharmaceutical ingredients, SAP systems, regulatory compliance, inventory management, RM , PM and GMP compliance.

hi we are hiring POSITION ;- Sr. Executive IPQA Location;- Baddi Experience ;- 7 years company;- Injection plant salary ;- 40 to 50 k

Role Overview Responsible for qualification & calibration of Microbiology instruments and equipment as per procedures with QMS. Illustrative Responsibilities Ensure that qualification & calibration activities are planned and executed within time frame defined by the procedure and equipments are released on time as per the pre-defined schedule. Responsible for coordinating with lab supervisors / system owners for handling of any non-conformances or escalations Handling of QMS related activities like, Change control, CAPA and Deviation with its effectiveness check. Responsible for quality compliance activities for laboratory instruments qualification and calibration. Summarize, review, and report the analytical Instruments qualification and calibration for further approval. Ensure a disciplined work environment to provide expertise to subordinates colleagues in the proper performance of laboratory procedures. Ensure on time GDP in technical function with right first time (RFT) approach. Responsible for ensuring team compliance to EHS, Quality & Business policies Any other work given by management from time to time. Quality & Compliance Responsible for following GMP/GLP/ GDP/EHS policies by self as well as the team Required skills Technical expertise in Microbiology instruments qualification, calibration, protocol preparation and QMS. Build cohesive team valuing team spirit Able to handle biosafety cabinet, LAF, glass bead sterilizer, water bath, Autoclave, refrigerator, Incubator, Balance & pH meter etc. Clear thoughts and effective and crisp communication. Job requirement M.Sc – specializing in Microbiology/Biotech with proven experience of min. 2-3 yrs. in Instrument qualification and calibration. Awareness of analytical instruments qualification and calibration, protocol preparation, CAPA, Investigations, Deviations (QMS) Good Knowledge of ICH guidelines and different global regulatory authorities. Job Location - Mulund

As an Electrical Engineer (Executive) at Dishman Carbogen Amcis Limited located in Bavla, Gujarat, IN, you will be responsible for managing electrical systems, breakdown maintenance, preventive maintenance, power consumption management, GMP compliance, safety, and project execution to ensure smooth and GMP-compliant operations in the pharma facility. Your role will involve reporting directly to the department reporting manager. You will be a key player in Facilities, Electrical Engineering, Electrical, Engineer, Operations, and Engineering, contributing to the overall success of the organization by ensuring the efficiency and compliance of electrical systems within the facility. Your primary duties will include overseeing the maintenance and management of electrical systems, ensuring timely and effective breakdown maintenance, implementing preventive maintenance schedules, optimizing power consumption, and ensuring compliance with GMP standards. Additionally, you will be involved in project execution related to electrical systems within the pharma facility. The ideal candidate for this role will possess a strong background in electrical engineering, with a focus on facility operations and maintenance. You should have a keen eye for detail, a proactive approach to problem-solving, and a commitment to ensuring safety and compliance in all electrical operations. If you are looking for a challenging and rewarding opportunity to make a significant impact in the pharmaceutical industry, this role as an Electrical Engineer (Executive) at Dishman Carbogen Amcis Limited could be the perfect fit for you. Join our team and be a part of our mission to deliver high-quality and GMP-compliant operations in the pharma sector.,

Roles and Responsibilities Prepare batch manufacturing documents, including BMRs, BPRs, and BPR reviews. Ensure compliance with GMP guidelines during API production. Conduct OOS investigations and implement corrective actions as needed. Collaborate with cross-functional teams to resolve documentation-related issues. Maintain accurate records of all documentation activities. Desired Candidate Profile 3-6 years of experience in API production or related field (document preparation). Strong understanding of GMP compliance and regulations. Proficiency in document preparation software such as BPR review tools. Experience with investigation procedures for OOS events.

You are competent in two engineering disciplines and possess thorough site knowledge. Your responsibilities include diagnosing and correcting equipment problems, maintaining facilities, and production equipment. You will also be involved in installation, testing, inspecting, and commissioning new electrical equipment, calibration of instrumentation, and rectification of regulatory deviations. Accountability is key as you will be responsible for maintaining and documenting maintenance work, improving maintenance procedures in compliance with GMP, and communicating effectively any issues during handover. Feedback on completed engineering tasks, including root causes and outstanding issues, is essential. You will be expected to use various systems such as WORKMATE, EDMS, BEAMEX, DRAWING DATABASE, MYPIRAMAL, and MICROSOFT OFFICE for different tasks. Additionally, following site systems for change control, safety, risk assessment, and waste handling is crucial in day-to-day activities. As part of your critical tasks, you must work safely, follow isolation procedures, participate in ESH tours and risk assessments, and attend mandatory training. Planning and scheduling tasks with customer departments, working autonomously, and supervising contractors are also part of your responsibilities. Essential qualifications for this role include BS:7671 18th Edition Wiring regulations, Compex certification, apprenticeship in electrical maintenance, and HNC qualification. Relevant experience in maintaining and installing electrical items, reading engineering drawings, and fault finding is required, along with pharmaceutical or chemical production experience. Piramal Group, where this job is situated, has a history of pursuing organic and inorganic growth strategies while upholding core values and inclusive practices. The organization values equal employment opportunities, making decisions based on merit and providing equal opportunities for all applicants and employees. Piramal Pharma Solutions (PPS) is a Contract Development and Manufacturing Organization (CDMO) offering a wide range of services across the drug life cycle. With a global network of facilities, PPS provides solutions in drug discovery, pharmaceutical development, clinical trial supplies, APIs, finished dosage forms, and specialized services like highly potent APIs, biologics, and more. As an integral part of the engineering team at Piramal Pharma Solutions, you will play a vital role in ensuring the efficiency, safety, and compliance of the operation. Your expertise and experience will contribute to the success of the organization's goals and objectives. This full-time engineering position is located at Whalton Road, Morpeth, United Kingdom, with the job identification number 6610.,

1)Compliance and Documentation Management 2) Quality Control Performance Metrics 3)Stability study & Documentation Oversight 4)Quality Management System (QMS) Management 5 to 10 years of relevant experience Should be familiar with cGMP practices.

Position: Production Head Experience: 10 To 20 Yrs Location: Bangalore Department: Manufacturing Industry: Medical Devices / Healthcare Technology Role Summary We are looking for an experienced and strategic Production Head to lead our manufacturing operations in the medical device domain. The ideal candidate will have deep knowledge of regulated production environments, strong people management skills, and a passion for driving quality, safety, and efficiency. This role is critical to ensuring that our products meet global standards and are delivered on time and within budget. Key Responsibilities Lead and oversee all daily manufacturing activities, ensuring production targets, timelines, and quality standards are met. Develop and implement effective production strategies aligned with company goals. Ensure full compliance with regulatory and quality standards, including ISO 13485, FDA21 CFR Part 820, and EU MDR. Manage cleanroom operations and ensure adherence to safety and hygiene protocols. Plan and optimize resource allocation including manpower, materials, and machines. Implement and promote Lean Manufacturing, 5S, Six Sigma, and other process improvement techniques. Coordinate with cross-functional teams such as Quality, R&D, Regulatory Affairs, SCM, and Maintenance. Oversee preventive and corrective maintenance of production equipment and ensure minimal downtime. Ensure documentation practices meet Good Manufacturing Practices (GMP), including DMR, DHR, CAPA, NCR, etc. Train, mentor, and lead the production team to drive productivity and accountability. Participate in internal, external, and regulatory audits. Qualifications Bachelors/Masters degree in Mechanical / Industrial / Biomedical Engineering or related field. Certifications in Lean, Six Sigma (Green/Black Belt), or ISO 13485 are an advantage. Experience 12-20 years of experience in manufacturing, with at least 5 years in the medical device or pharma industry. Prior leadership role in managing large-scale, regulated production lines. Key Competencies In-depth knowledge of regulatory standards (ISO 13485, GMP, FDA, EU MDR). Excellent team leadership, communication, and conflict-resolution skills. Proven track record in implementing continuous improvement and cost-saving initiatives. Hands-on experience with ERP/MES systems. Strong analytical and decision-making abilities. Why Join Us? Opportunity to lead in a fast-growing, innovation-driven organization Work on cutting-edge medical technologies that impact lives A culture that values quality, teamwork, and continuous learning

Production: Execute production batches, ensure GMP, manage documentation QA: Ensure cGMP, Issuance and retrievals and manage records. QC: Analyze biopharma samples & maintain Documentation R&D: Prepare stocks and buffers, extract proteins & analyze.

Role & responsibilities Working on unit operations related to upstream processing during DS Manufacturing. GMP Documentation related to DS manufacturing. Preparation of documents like SOPs, MMDs and QMS related documents like change control, deviation, CAPA, Risk assessment. Preparation and maintenance of virus stocks. Coordination with cross-functional team. Involvement during regulatory audit preparation. Preferred candidate profile Must have experience in Biopharma

We are a Pharma Mfg located in Dabaspet. We are looking to hire QA Executive for our Tablets mfg and pkg dept. who will be dedicated full time. B.Pharma. Minimum Exp. (3-5 years OSD formulation). Interested send resume to watsapp 9739978848

Role & responsibilities: Outline the day-to-day responsibilities for this role. Preferred candidate profile: Specify required role expertise, previous job experience, or relevant certifications.

We are seeking an experienced professional to join our Biotech Production Department in India. The ideal candidate will have a strong background in biotech production processes and will be responsible for overseeing and optimizing production operations. Responsibilities Oversee the production processes in the Biotech department ensuring compliance with industry standards. Assist in the scale-up of bioprocesses from laboratory to production scale. Conduct routine maintenance and troubleshooting of bioprocess equipment. Collaborate with cross-functional teams to ensure timely and efficient production schedules. Ensure adherence to safety and quality protocols throughout the production process. Skills and Qualifications Bachelor's degree in Biotechnology, Bioengineering, or related field. 3-6 years of experience in biotech production or a related area. Strong understanding of bioprocessing techniques and equipment. Familiarity with regulatory guidelines and Good Manufacturing Practices (GMP). Excellent problem-solving skills and attention to detail. Ability to work effectively in a team-oriented environment and communicate clearly.

Role & responsibilities Responsible for In-process production related activities in DP manufacturing, filling, and packing sections Preparation of batch manufacturing records, process validation protocol/report of DP area and its associated records Responsible for calibration and qualification program of equipment of DP area Execution and review of IQ, OQ, PQ of equipment. Perform the Qualification/Verification of equipment's and compilation of PV documents of the DP Area

Execute MFg./Packing/Testing activities as per GMP Std., Maintain Record BMR/BPR, Perform in process check & document deviations, SOP Procedures, Line clearance Report.. capa, market complain etc...

Role & responsibilities: To maintain the laboratory with respect to availability of chemicals, reagents, glass wares, working standards and reference standards etc. To see that all the instruments logbooks are maintained. To complete the reports of Stability/Raw material/In-process/Intermediate/Finished goods. To make entry of plant samples in the relevant registers. Calibration of QC instruments and Stability chamber. To maintain the cleanliness in the quality control department. To perform analytical method validation. To prepare the analytical protocols and reports of validation. To perform Stability sample Analysis. To perform analysis of cleaning samples. Destruction of Intermediate, Raw Material, Finish Product samples and stability sample. To record daily temperature monitoring of wet laboratory, Control sample. Stability Activity sample planning Analysis, Reviewed ,Trend Preparation Reviewed of Stability sample, In process, Intermediate, Finished Goods, Raw Material in GC, HPLC and Weight lab section. Integration and report of Stability Product To check and record of temperature and humidity control in reserve samples room and stability chambers. Stability chamber problem and follow up from vendor. To perform Particle Size Analyzer analysis of In-process and Finished goods material. Calibration of Stability chamber. Preferred candidate profile: 3-6 Years of experience in Quality Control. B.sc /M.sc (Chemistry) Strong knowledge of method validation, GMP compliance and Stability section.

Supervise entire plant operations and manpower management at Byadgi unit. Data collection & compiling. Prepare reports. Responsible for food safety practices, GMP. Required Candidate profile B.E. or Diploma in Chem/Mech or M.Sc. Food Technology with 2-6 years' exp. Work in shifts. Knowledge of food safety, GMP. Exp in food/pharma/solvent extraction/continuous process industry.

Filling & review BMRs, MFRs, SOPs, ECR Maintain records for CC, CCF Ensure documentation aligns with GMP Requirement Support audits & investigations with accurate records. Coordinate with production & QA for data verification. Required Candidate profile Must Require Knowledge for filling & Review of BMR BMR, CC, CCF, and OOS handling Documentation practices & regulatory understanding Good communication & MS Office proficiency

WHO-GMP guidelines, pharmaceutical material handling, inventory systems (ERP/SAP) Material handling, storage, and movement comply with WHO-GMP Strong expertise in pharmaceutical warehousing, inventory control, regulatory compliance, cross-functional. Required Candidate profile Lead day-to-day warehouse operations receipt, storage, issuance, and dispatch of raw materials, packaging materials, intermediates, finished goods. Relevant experience in a pharmaceutical warehouse

Looking for a Sr. Admin Executive to handle daily admin and facility operations at our Palghar plant. Key duties include maintaining cleanliness, SOP compliance, supervising housekeeping, managing inventory, and coordinating factory AMC follow-ups. Required Candidate profile similar role, preferably in a factory/industrial setting Good knowledge of facility operations, housekeeping, AMC follow-ups & inventory control Willing to visit plant and work from 8:00 AM to 6:00 PM