33 Batch Records Jobs

As a QA Manager at Vedic, you will play a pivotal role in exploring the cutting edge of personal care product innovation. You will be part of a dynamic team that values talent, growth, and well-being. Key Responsibilities: - Creation, approval, and implementation of quality systems and procedures at the site - Review and approval of master documents such as SOPs, Protocols, Batch Records, Specifications, etc. - Participation in the investigation and approval of events including deviations, temporary changes, non-conformance, Out of Specification (OOS) results, and failures Qualifications Required: - Masters degree in finance, accounting, or a related field - Qualified chartered accountant pr...

As a Formulations Scientist in Hyderabad, India, you will be responsible for the development of oral solid dosage forms of Non-DEA and DEA substances. Your key functions will include conducting Literature Search, Pre-Formulation, Formulation Design, and Development of stable, Bioequivalent, and Manufacturable generic solid oral formulations. Your responsibilities will include: - Being a good mentor and motivator to the team. - Developing robust formulations and processes for immediate release and modified release tablet and capsule dosage forms. - Evaluating patents and developing non-infringement strategies, including the capability of developing Paragraph IV products. - Scaling up and opti...

As a Pharmaceutical & Life Sciences professional, your role involves ensuring that all pharmaceutical products developed with the R&D Department meet the highest quality standards. Your key responsibilities include: - Preparing and reviewing regulatory dossier documents for DCGI, ROW, and Export market business. - Implementing and maintaining quality assurance systems and procedures for dosage preparation. - Ensuring compliance with Good Manufacturing Practices (GMP), Good Laboratories Practices (GLP), and other relevant regulatory standards. - Collecting, organizing, and reviewing documents from F&D, ADL, and other relevant departments. - Managing quality documentation and records, includin...

As a Chemical Engineer at Ambica Industries in Howrah Domjur, you will play a crucial role in overseeing production processes, ensuring efficient plant operations, maintaining quality standards, and managing manpower in the chemical manufacturing unit. You are expected to have a strong technical knowledge of chemical processes, production operations, and handling shop-floor teams. **Key Responsibilities:** - Oversee daily production operations and ensure adherence to production plans and timelines. - Monitor, optimize, and control chemical processes to achieve maximum efficiency. - Ensure all SOPs, safety protocols, and quality standards are followed strictly. - Manage and supervise producti...

Your role involves establishing and maintaining a comprehensive document control system for all manufacturing processes, including batch records, standard operating procedures (SOPs), and quality control documentation. You will ensure that all documentation complies with relevant regulatory requirements, industry standards, and Good Manufacturing Practices (GMP) for Ayurvedic products. It is essential to stay informed about changes in regulations and update documentation accordingly. Your responsibilities also include compiling and reviewing batch records, as well as conducting regular audits of documentation for accuracy and completeness. You will be responsible for maintaining a systematic...

Job Description: As a Chemical Process Operator, you will be responsible for operating, monitoring, and controlling various chemical process equipment such as reactors, mixers, distillation columns, and filtration systems. Your key responsibilities will include: - Handling raw materials and finished products, which involves tasks like loading, unloading, weighing, and labeling. - Following Standard Operating Procedures (SOPs), batch records, and safety protocols diligently to ensure smooth production activities. - Conducting in-process checks and maintaining accurate records of production data including temperature, pressure, and batch times. - Performing basic troubleshooting of equipment a...

You will be responsible for overseeing day-to-day production activities in accordance with company standards and regulatory guidelines. This includes ensuring accurate formulation, mixing, and processing of raw materials. You will also be in charge of monitoring batch records and maintaining proper documentation of production activities. Additionally, conducting in-process quality checks and ensuring compliance with GMP (Good Manufacturing Practices) will be part of your key responsibilities. You will need to coordinate with the R&D and QC teams to resolve any technical issues that may arise. It is important to maintain safety, cleanliness, and efficiency in the production area at all times....

Job Title: QA Officer Department: Quality Assurance Location: Neemrana, Rajasthan Company: VRB Consumer Products Pvt. Ltd. About the Company: VRB Consumer Products Pvt. Ltd. is a fast-growing FMCG company focused on producing safe, high-quality, and innovative consumer products. With strong manufacturing capabilities and a commitment to continuous improvement, we are expanding our quality team at our Neemrana plant. Job Summary: We are looking for a detail-oriented QA Officer to support daily quality assurance activities, including in-process checks, documentation, and implementation of quality systems. The ideal candidate will ensure adherence to company standards, GMP, and regulatory requi...

As a Quality Assurance Specialist at our company, your main responsibilities will include: - Reviewing paper and electronic batch records on completeness, clarity, and GMP compliance - Reviewing raw material related documentation and releasing raw materials - Providing quality support for the development of appropriate Corrective and Preventative Actions (CAPAs) - Offering advice to requesting departments regarding GMP aspects - Reviewing and approving QA controlled documentation such as SOPs, batch records, and working instructions - Assessing change requests for consistency, relevance, GMP compliance, and clarity - Reviewing and preparing batch release documentation - Supporting continuous...

As a Research and Development Operator I at our company, your role will involve operating, cleaning, disassembling, and reassembling equipment such as blending, granulation, compression, and coating machinery in accordance with applicable cGMPs and SOPs. You will rotate between the Pilot Plant and Manufacturing departments based on business needs. This position is safety-sensitive. **Key Responsibilities:** - Proficiently operate, disassemble, assemble, and clean equipment. - Perform housekeeping tasks to maintain cleanliness and routine maintenance of the work area and equipment. - Utilize computer systems to read, review, and train on SOPs. - Review current SOPs and suggest process improve...

Role Overview: As a Consultant in Blending & Tank farm, your main responsibility will be producing various product blends as per specifications provided by the Commercial team. You are expected to meticulously follow blend sheets, batch records, and outlined procedures to ensure accurate production of product blends and lot combinations. It is crucial to accurately pull specified streams and lots, document all actions, oils, lots, locations, and weights of oil used in production. Utilizing Good Manufacturing Practices (GMP) to prevent contamination and enhance production efficiency is a key aspect of your role. Collaboration with other blending specialists and manufacturing personnel is esse...

Key Responsibilities: Terminal Sterilization Block Operations (Solution/Emulsion Preparation, Vial/Ampoule Washing, Depyrogenation, Filling, Capping, and Collection) Ensure compliance with current Good Manufacturing Practices (cGMP) across all sterilization block operations Maintain regulatory standards and documentation in alignment with cGMP requirements Adhere to Pfizer manufacturing policies and procedures Review Electronic Batch Records (eBR) and assess AMPS (Agile Manufacturing Production System) exceptions with supervisor support Audit batch reports and equipment trails for accuracy and compliance Conduct alarm impact assessments and approve trend reports Monitor start-up and in-proce...

Role Overview: As a Formulations Scientist in Hyderabad, India, you will be responsible for the development of oral solid dosage forms of Non-DEA and DEA substances. Your key functions will include conducting Literature Search, Pre-Formulation, Formulation Design, and Development of stable, Bioequivalent, and Manufacturable generic solid oral formulations. Key Responsibilities: - Act as a mentor and motivator to the team. - Develop robust formulations and processes for immediate release and modified release tablet and capsule dosage forms. - Evaluate patents and develop non-infringement strategies, including the capability of developing Paragraph IV products. - Scale-up and optimize manufact...

As a QA Manager at Vedic, you will play a crucial role in ensuring the quality of personal care products by overseeing the creation, approval, and implementation of quality systems and procedures at the site. Your responsibilities will include: - Reviewing and approving master documents such as SOPs, Protocols, Batch Records, Specifications, etc. - Participating in the investigation and approval of events like deviations, temporary changes, non-conformance, Out of Specification (OOS) results, and failures. To excel in this role, you should possess the following qualifications: - Master's degree in finance, accounting, or a related field - Qualified chartered accountant professional with a mi...

Role Overview: As a Document Control Specialist, your primary responsibility will be to establish and maintain a comprehensive document control system for all manufacturing processes. This includes managing batch records, standard operating procedures (SOPs), and quality control documentation. Your role is crucial in ensuring that all documentation complies with relevant regulatory requirements, industry standards, and Good Manufacturing Practices (GMP) especially for Ayurvedic products. Staying updated on regulatory changes and ensuring documentation is up-to-date is a key aspect of your role. You will also be responsible for compiling and reviewing batch records, conducting regular audits ...

You are invited to join Sinterx Pharma Private Limited as a Production Chemist where you will play a crucial role in the manufacturing of pharmaceutical products. Sinterx Pharma Pvt Ltd is an emerging company based in Hyderabad, with a dedicated team and strong industry connections. **Responsibilities:** - Assist in the preparation and execution of chemical production batches following standard operating procedures (SOPs) to maintain product quality. - Safely handle pyrophoric reagents, Raney nickel, and operate pressure reactors (autoclave) in accordance with company policies. - Conduct filtration of low-melting solids using optimal techniques. - Report any deviations from specifications an...

Job Title: Production Executive No. of Positions: 2 Company Name: The South Indian Manufacturing Company Company Website: www.saibol.com Location: Madurai (Local candidates preferred or must be willing to relocate) About the Company The South Indian Manufacturing Company is a reputed pharmaceutical manufacturer specializing in quality-driven processes and GMP-compliant production systems. Qualifications B.Pharm / M.Pharm / B.Sc Chemistry / M.Sc Chemistry Experience Freshers (0-2 years) are eligible Experienced candidates (3+ years) also welcome; higher salary will be offered based on profile Key Responsibilities Assist in ointment manufacturing (weighing, mixing, filling, packing, labeling) ...

Azurity Pharmaceuticals is a specialty pharmaceutical company dedicated to providing innovative products for underserved patients. With a focus on unique, accessible, and high-quality medications, Azurity continuously expands its commercial product portfolio and late-stage pipeline through integrated capabilities and a vast partner network. The company's patient-centric products cover various markets including cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan, benefiting millions of patients globally. As an inclusive workplace and Equal Opportunity Employer, Azurity attributes its success to a talented and dedicated team committed to improving patients" l...

Dr. Reddys is looking for Manufacturing Scientists or senior scientists specialized in cell therapy (CAR-T) programs to join their Manufacturing facility team. As a Manufacturing Scientist, you will collaborate with Research and Product Development teams to support GMP Manufacturing operations, Technology transfer, quality assessments, and process validation of the CAR-T process for various Cell therapy programs. Your responsibilities will include designing and executing experiments to develop robust manufacturing processes for cell therapy products, leading and training a team of cell process scientists/engineers, managing T-cell culture and differentiation, documenting experimental procedu...

The Peptides Production Manager will oversee and manage the end-to-end production activities for peptide synthesis, ensuring timely delivery, compliance with quality standards, and adherence to regulatory requirements. You will be responsible for process optimization, team management, and collaboration across departments to achieve production targets effectively and efficiently. Key Stakeholders: Internal Quality, R & D, Engineering, and support functions Key Stakeholders: External Vendors and Customers on a need basis Reporting Structure This position will report to Chief Manager Production Experience Minimum of 10 to 15 years of experience with peptide API manufacturing for regulated marke...

The Associate, Regulatory Affairs is responsible for supporting regulatory efforts related to the submission of supplemental ANDAs, ANDA Annual Reports, Drug Listing, SPL/PLR (labeling), and other regulatory compliance matters to assist the company's approved product portfolio, both internally and externally. Key responsibilities include: - Compiling and submitting Post Approval Supplements such as PAS, CBE-0, CBE-30. - Preparing, reviewing, and submitting amendments and supplements for assigned products. - Preparing, reviewing, and submitting responses to the Agency's queries for assigned products. - Compiling and submitting Global Annual Reports. - Reviewing stability protocols and reports...

As an integral member of our team at Piramal Pharma Solutions (PPS), you will play a crucial role in supporting the day-to-day operations of the pilot plant under supervision. Your responsibilities will include assisting in the scale-up of processes from laboratory to pilot plant scale for API manufacturing. You will be responsible for setting up equipment, operating various pilot-scale processes, and troubleshooting as needed. In this role, it will be essential for you to monitor and record operational data meticulously to ensure strict adherence to safety, quality, and environmental standards. Additionally, you will contribute to the preparation of batch records, standard operating procedu...

We are looking for an innovative and experienced quality analyst to join our team. The quality analyst is responsible for developing and supporting the planning, design, and execution of test plans, test scripts, and process plans for projects. The successful candidate will work closely with various departments to perform and validate test cases based on quality requirements, and recommend changes to predetermined quality guidelines. You will be responsible for ensuring that the end product meets the minimum quality standards, is fully functional and user-friendly. To be successful as a quality analyst, you should demonstrate strong attention to detail and have analytical and problem-solving...

As a Quality Assurance Specialist, you will be responsible for reviewing paper and electronic batch records to ensure completeness, clarity, and compliance with Good Manufacturing Practices (GMP). Your role will involve assessing the documentation related to raw materials and releasing them for production. You will provide quality support by contributing to the development of Corrective and Preventative Actions (CAPAs) and offering guidance to various departments on GMP aspects. Additionally, you will review and approve quality assurance controlled documents such as Standard Operating Procedures (SOPs), batch records, and work instructions. In this position, you will be tasked with evaluatin...

Role & responsibilities Preparation of protocols in line with international standards and executing the heat-sealing machine validation as per the defined frequency. Preparation of protocols in line with ISO 11135 & ISO11137 for the EO & Gamma radiation sterilization process validation and executing the validation activities. Preparation of protocols as per international standards and executing the validation activities for all the manufacturing & testing processes. Co-ordinating with maintenance team and other teams to prepare the IQ & OQ protocols and reports. Co-ordinating with external service provider to complete the software validations. Conducting the in-house calibrations as per the ...