6 Gmp Standards Jobs

As a Supervisor at Sigachi located in Dahej, you will play a crucial role in ensuring the smooth production operations in line with GMP standards. Sigachi, a renowned manufacturer of Excipients for Pharma, Nutra, and food industries, has been a key player in the market since its inception in 1989. With multiple facilities in Telangana and Gujarat, Sigachi has solidified its position as a leading producer of Microcrystalline Cellulose globally. Operating under various certifications like EXCiPACT GMP, SGMP, HACCP, EDQM CEP, and ISO 9001:2015, Sigachi has built a reputation for delivering high-quality products across continents. Your primary responsibilities will include planning and organizing production schedules to meet targets for output, quality, and yield. You will oversee all production operations to ensure compliance with SOPs and GMP standards. Collaborating closely with the Quality Control department, you will focus on continuous improvement and effective resource utilization to maintain quality parameters. Additionally, you will coordinate with cross-functional teams, particularly the Engineering Department, to ensure the production of top-notch quality products. It will be your duty to provide on-the-job training for production staff and maintain updated training records. You will be responsible for reporting deviations, conducting investigations, and implementing corrective and preventive actions as necessary. Moreover, your role will involve coordinating with QA for batch release, investigating non-conforming batches, and ensuring batch identification and traceability. Maintaining equipment/instruments calibration, practicing good housekeeping, and adhering to gowning procedures are also part of your responsibilities. In terms of qualifications, we are looking for candidates preferably with a B.Sc, M.Sc, B.Pharm, M.Pharm, or B.Tech (Chemical) degree. An experience of 8 - 10 years in the Pharma Industry or Excipient Manufacturing sector will be highly advantageous for this role. If you are a self-driven professional with a keen eye for detail and a strong background in production operations, this position at Sigachi offers a challenging yet rewarding opportunity to showcase your expertise and contribute to the company's commitment to excellence.,

You should have an ITI or Diploma in Electrical Engineering or equivalent qualification. Additionally, you should possess at least 3 years of experience working as an industrial electrician in a pharmaceutical or GMP-regulated manufacturing environment. Your role will require a strong understanding of industrial wiring, control panels, and basic PLC operations. It is essential that you can read and interpret electrical drawings and schematics proficiently. Knowledge of GMP standards is mandatory, and you should be willing to work in shifts if required. Preferred skills for this role include basic knowledge of automation systems, familiarity with cleanroom operations, and pharma-grade equipment. You should also have a quick problem-solving ability and be capable of working efficiently under pressure. As an industrial electrician, your key responsibilities will involve carrying out preventive and corrective maintenance of production machinery, electrical systems, and control panels. You will be expected to diagnose and repair electrical faults promptly, ensuring all electrical work complies with GMP and safety standards. It is crucial to maintain detailed documentation of maintenance and repair work, assist in equipment calibration and validation, and provide support during regulatory audits. Collaboration with production and QA/QC teams to minimize equipment downtime and managing inventory of electrical spare parts and tools are also part of your responsibilities. This is a full-time, permanent position with benefits including Provident Fund and a yearly bonus. The work schedule may include day shifts, rotational shifts, day shift availability, and night shift availability. The work location is in person.,

As a Production Manager at Natural Biogenex Pvt. Ltd. (NBPL), a subsidiary of Natural Capsules Limited, located in Vasanthnarasapura KIADB Industrial Area, Tumkur, Karnataka, you will play a crucial role in overseeing and managing API production operations. With 10-15 years of experience in the industry and a background in MSc.(Organic Chemistry)/ MTech Chemical (Technology)/ BSc.(Chemistry), you will ensure the highest quality standards for pharmaceutical ingredients in compliance with international regulatory bodies such as USFDA, WHO, and ICH-Q7A. Your responsibilities will include supervising day-to-day shop floor operations, workforce management, batch planning, and execution. Your expertise in utility operations, shop floor management, and troubleshooting production issues will be essential in maintaining compliance with GMP standards and regulatory guidelines. You will lead customer and regulatory audits, oversee finished goods handling, and ensure customer requirements are met. Key Responsibilities: - Supervision of day-to-day shop floor operations and workforce management. - Ensuring batch planning, timely execution, and adherence to production timelines. - Troubleshooting production and operational issues efficiently. - Ensuring compliance with quality guidelines and regulatory standards (GMP, ICH-Q7A, USFDA). - Experience in unit operations, including reactors, clean room operations, jet mills, AHU, and related utilities. - Managing documentation according to SOP and GMP guidelines. - Leading customer and regulatory audits, including USFDA, TGA, and WHO Geneva. - Training and developing team members to enhance departmental performance. - Coordinating for BOQ preparation and store management. - Overseeing finished goods handling and ensuring customer requirements are met. Qualifications: - Education: MSc.(Organic Chemistry)/ MTech Chemical (Technology)/ BSc.(Chemistry) - Experience: Minimum of 12 - 15 years of experience - Knowledge: Strong understanding of various production compliances and strategies. - Skills: Excellent communication, organizational, and project management skills. Ability to work collaboratively in a fast-paced environment. Join us at NBPL to be a part of a leading API manufacturing company with cutting-edge technology, global compliance standards, and the opportunity to contribute to regulatory audits and pharmaceutical quality excellence. Competitive salary and professional development opportunities await you in our state-of-the-art Quality Control Laboratory.,

The job involves being a team member of the Engineering Maintenance & Reliability Team within the Active Pharmaceutical Ingredient department of the Manufacturing division. Your primary responsibility is to execute maintenance activities in the plant, ensuring minimal breakdowns and maximum efficiency while adhering to safety and GMP standards. You will support the Senior Engineer in planning, scheduling, and executing maintenance activities to ensure plant and equipment availability, capacity, integrity, and reliability as per company policies and procedures. Additionally, you will be responsible for maintenance tasks in the Manufacturing, Packing, and utility areas as assigned by the Senior Engineer. In this role, you will be accountable for executing shift maintenance activities, including managing available resources to achieve maintenance targets, analyzing breakdowns, diagnosing faults, and supervising equipment repairs. You will also be involved in executing a comprehensive maintenance plan, preventive maintenance, calibration, and condition monitoring activities, ensuring adherence to standards and documenting all related activities. Handling breakdown maintenance to prevent recurrence, operating equipment efficiently as per SOP, implementing new technologies to improve machine performance, managing spares, adhering to EHS compliance, and ensuring cGMP compliance are also key aspects of the role. Moreover, you will be required to provide suggestions for process optimization, continuous improvements, and self-development in mechanical engineering and leadership aspects. Major challenges include adherence to budget constraints, cost vs. performance trade-offs, aging assets leading to escalating costs, and ensuring personnel and service providers" capability and competence. You will interact internally with Central Engineering, EHS, Site and Unit heads, and externally with OEMs, maintenance contractors, industry bodies, and statutory bodies. The role requires a BE/BTech in Mechanical Engineering with 2-5 years of experience in manufacturing, maintenance, and projects. You should have a deep understanding of manufacturing processes, organizational skills, technical knowledge of Pharma/API machinery, experience in project execution, knowledge of GMP and regulatory requirements, and leadership skills in mechanical engineering activities.,

Key Responsibilities: Create and review Process and Instrumentation Diagrams (P&IDs) following industry standards and GMP requirements. Develop 3D models for process skids and plant piping systems using industry-standard software (e.g., AutoCAD Plant 3D, REVIT). Coordinate with multi-disciplinary teams including process, mechanical, and automation engineers. Ensure compliance with ASME BPE standards. Essential Skills: Experience with modular/skid design. Knowledge of cleaning and sterilization processes. Strong analytical and problem-solving abilities. Excellent attention to detail. Good communication and documentation skills. Ability to work independently and as part of a team.

KEY RESPONSIBILITIES The incumbent will work closely with the Corporate Quality Assurance teams under the supervision of the Digital Business Partner, leading articulation of key technology and digital requirements and ensuring successful rollouts. More specifically s/he will lead the following responsibilities: Business Analysis: Point of contact and between business, IT, end user and other cross functional teams during the project or maintenance phase. Collect data, analyse & define the business and user requirements. Analyse business problems and facilitate in IT solution evaluation. Work closely with managers and end users to have buy-in for the proposed solution. Creating a detailed business analysis, outlining problems, opportunities, and solutions for the business users and stakeholders. Categorize the functional and non-functional requirements of the business. Conduct post project implementation acceptance and requirements reviews. Perform additional tasks as assigned by the reporting manager, time-to-time basis in DevOps mode. Prepare validation documentation related to release of GxP system. Should have sound knowledge on preparing validation artifacts for GxP IT systems. Should have knowledge of GxP system testing and validation. Sound communication skill with good amount of convincing power (intermediate level). An ideal candidate should be well planned and structured in his/her all deliverables. Must have experience in Pharma IT with hands-on expertise for handling GxP systems. IT Support and Maintenance: Provide IT administrative support for Enterprise systems but not limited to the following. User Management (Creation, Modification, Password reset etc.). User Access Rights Management. Active user list preparation. Support to Biocon users on the enterprise application on service requests, incidents and bug fixes. Periodic review of event logs (as where applicable). Provide support to vendor for fixing IT related issues during breakdowns. Responsible for adoption, creation and Maintenance of Quality Management Procedures as per IT Operation requirements. 1st level Point of Contact for all IT related queries from Biocon users for enterprise systems Co-ordination with Enterprise functional Team for finding the RCA from IT Perspective in their Incidents and CAPAs. Responsible for implement Change controls and log Incidents and deviation related to IT Functions. Responsible for adherence of SLA's defined for various IT administrative support activities. PROFESSIONAL EXPERIENCE / QUALIFICATIONS Bachelor's in Engineering or Master's degree in a related discipline, including a minimum of 4-6 years of experience gained in technology implementation in the Pharma space Specific experience as a Business Analyst in a GxP application for a pharma company Excellent oral/ written communication skills Self-starter, with the ability to work and execute independently with minimal oversight.