8 Cgmp Practices Jobs

The Shift Incharge in Pharma Manufacturing is responsible for achieving the desired production yield of pharmaceutical APIs. This role involves carrying out production activities, material management, and manpower supervision in compliance with standard operating procedures, quality standards, and safety norms. Key Responsibilities: - Proper takeover of shift operations as per defined procedures - Following gowning procedures before entering the pharma area - Ensuring receipt of raw materials from stores and updating material reconciliation records - Collecting intermediate materials from the designated area - Ensuring availability of utilities before charging the batch - Executing production processes, recording parameters, and ensuring adherence to cGMP practices - Ensuring compliance with EHS requirements on the production shop floor - Conducting filtration activities and maintaining housekeeping and hygiene standards - Ensuring pest control in the shop floor area - Dispensing samples to QC and handling packing activities - Facing audits and supervising shift chemists and casual labor - Reporting abnormalities or deviations to the immediate supervisor - Handling documentation activities including record-keeping and handover - Coordinating with plant maintenance for preventive and shutdown maintenance - Ensuring compliance with temperature, pressure, and humidity requirements - Completing assigned trainings and applying knowledge in the workplace Qualifications and Experience: - Education: B.Sc. (Chemistry) minimum, M.Sc. (Chemistry) preferred - Experience: Minimum 6 years, preferred 8 years in production and quality systems, regulatory guidelines, and EHS requirements in pharmaceutical API companies Competency Requirements: - Functional: Understanding systems and processes, execution, and resource utilization - Behavioral: Attention to detail, teamwork, problem-solving, and supervision This role requires a proactive individual with a strong background in pharmaceutical manufacturing, quality control, and regulatory compliance. The Shift Incharge must demonstrate leadership skills, attention to detail, and the ability to work effectively in a team environment.,

This job role involves the documentation activities conducted at the Par Formulation Indore Sterile Facility. As a personnel in this role, your main responsibilities include managing documentation and training, as well as handling various software such as Doc pro, Veeva, and Compliance wire (LMS). Your tasks will include: - Issuing Records of Analysis - Issuing controlled and uncontrolled copies of standard operating procedures - Issuing protocols, reports, layouts, and forms - Issuing logbooks and drawings - Following cGMP practices according to defined procedures - Performing distribution, retrieval, and destruction of documents as per procedures - Maintaining employee training files - Ensuring document controls on-site (Master Production Records/Packaging Records/Analytical Documents, etc.) - Managing master and controlled documents in the Documentation Cell - Assigning document numbers and equipment numbers as per defined procedures - Stamping controlled and uncontrolled copies and recording entries in respective formats - Initiating change control related to document cell activities - Generating Daily QMS data sheets as required and tracking pending documentation tasks. In this role, attention to detail, adherence to procedures, and proficiency in document management software are essential for successful completion of tasks.,

The responsibilities and duties of this role include: - Performing sampling and analysis of Raw materials, Packing materials, In process, Intermediate, and Finished products. - Conducting calibration of Quality Control instruments. - Carrying out Stability/Holding time studies. - Managing Reference Standards and qualifying Working Standards. - Ensuring Analyst qualifications are met. - Conducting Analytical Method Validation. - Managing Control samples (Retain sample). - Conducting OOS investigations (Phase-1). The ideal candidate should have: - 2-3 years of experience in Pharmaceutical Quality Control. - Educational background in M.Pharmacy/B.Pharmacy/M.Sc. (Chemistry)/B.Sc. (Chemistry). - Preferred experience in handling HPLC, GC, and other Quality Control instruments. - Good documentation skills with exposure to GLP, GDP, and cGMP practices. - Experience in Sampling and analysis, Calibration, Stability/Holding time studies, Analytical Method Validation, and OOS investigations. Benefits: - Competitive wages and benefits. - Yearly bonus. - Increments every year based on performance. - Training opportunities. - Lunch service. - Commuting support.,

You are invited to join Global Calcium Pvt. Ltd., a prominent API manufacturing company located in Bangalore, India, specializing in speciality API's, benzodiazepines, ophthalmics, oncology, chelated minerals, and organic mineral salts. We are currently seeking talented individuals to fill various roles in the QC Department. Open Positions: - QC ICP-MS Analyst (2 openings) - QC DMF Support (2 openings) - QC Analytical Validation Support (2 openings) - QC Wet Analysis (2 openings) Qualifications: - B.Sc./M.Sc. in Chemistry or related fields - 1 to 4 years of relevant pharmaceutical QC experience - Familiarity with cGMP practices and regulatory compliance Responsibilities: - Perform routine and non-routine analyses using analytical techniques and instruments - Develop and validate analytical methods and protocols - Prepare and maintain detailed documentation and reports - Ensure adherence to regulatory guidelines and GMP standards - Collaborate with other departments for cross-functional projects - Participate actively in laboratory investigations and troubleshooting activities Walk-in Interview Details: - Venue: Global Calcium Pvt. Ltd., Unit III, 19 & 19B, Sipcot Industrial Complex, Phase - 1, Dharga, Hosur - Date: 14th June 2025 - Time: 9:30 AM to 11:00 AM Please note that only candidates with relevant experience in the pharmaceutical QC domain will be considered for these positions. Benefits and Perks: - As per industry standards If you possess the required skills and experience in DMF preparation, UV, regulatory documentation, elemental impurity analysis, cGMP practices, HPLC, GC, classical wet chemistry techniques, quality control, ICP-MS, wet analysis, and method validation techniques, we encourage you to attend the walk-in interview and become a part of our dynamic team at Global Calcium Pvt. Ltd.,

The Regulatory and Quality Manager role in Noida requires a female candidate and involves various responsibilities related to quality management and regulatory compliance. You will be responsible for implementing the Quality Management System in alignment with regulatory requirements. This includes managing regulatory documentation and overseeing the Continual Improvement of Systems, Product Quality Review Process, Corrective and Preventive Action System. Your accountability extends to ensuring data integrity and implementing SOPs and policies. You will evaluate and approve master documents across different departments and prepare and approve various master documents such as BMR, SOP, STP, SPEC, formats, and checklists. Additionally, you will manage Control Sample and Stability Management, implement QA systems for compliance with SOPs, and handle both external and internal audits. You will review, evaluate, and approve documents on behalf of the factory department under the guidance of the technical head. As part of your responsibilities, you are expected to adhere to cGMP practices and ensure the proper implementation of recorded information. Furthermore, you will review and approve equipment qualification/requalification/validation protocols and compile summary reports of the products. If you are interested in this position, please send your application to pharmahr@bjainpharma.com.,

The Shift Chemist at Pharma Manufacturing department is responsible for achieving the desired production yield of pharmaceutical APIs by ensuring all production activities in the shift comply with cGMP, cGLP, EHS requirements, and specified operating procedures. You will be required to properly take over shift operations as per defined procedures. This includes following the Gowning Procedure before entering the pharma area, indenting raw materials from stores, updating balance in Material Reconciliation Record, collecting Intermediate material, ensuring availability of Utilities before charging the batch, verifying and charging raw material quantities, executing production process, recording process parameters progressively in Batch Manufacturing Sheet, participating in cleaning and process validation during batch startup process, and carrying out Filtration Activities. It is essential to adhere 100% to cGMP practices in line with 21 CFR, as well as EHS requirements applicable to the production shop floor. Maintaining Housekeeping and Hygiene in the shop floor area, ensuring Pest Control, dispensing required samples to QC, performing packing activity, and dispensing finished material to stores for dispatch are also key responsibilities. Timely reporting of abnormalities/deviations to the immediate supervisor/appropriate authority is crucial. You will be responsible for live recording of each activity in Batch Manufacturing Sheet and other records, as well as handover completed documents to Shift Incharge/ongoing documents to reliever. Additionally, providing support to plant maintenance staff for preventive maintenance schedules, coordinating with plant maintenance team to ensure temperature, pressure, and humidity, resolving breakdowns during the shift, and successfully completing assigned trainings are part of the role. The ideal candidate should have a minimum of a B.Sc. in Chemistry (preferred M.Sc. in Chemistry) and at least 2 years of experience in production and quality systems, regulatory and cGMP guidelines, and EHS requirements in Pharmaceutical API companies. Key competencies required for this role include the ability to understand systems and processes, execution, optimum utilization of resources, attention to detail, teamwork, and problem-solving skills.,

Egg Handling Pre-incubation Egg Candling Allantoic Fluids/Embryo Harvesting Inactivation Aseptic Handling and Sampling cGMP Practices Documentation

Egg Handling Pre-incubation Egg Candling Allantoic Fluids/Embryo Harvesting Inactivation Aseptic Handling and Sampling cGMP Practices Documentation