25 Batch Records Jobs

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 ...

Role & responsibilities To carry out planning for production process as per the requirement Create Batch Record as per the requirement Ensure production process is carried out as per plan Monitor the process and resolve any problems / issues Ensure to meet quality and production requirements Ensure to meet quality and hygiene requirement during production process Guide and train the team members Maintain all the planning of work in printing area Based on the Order requirement done the printing within the time. Strict adherence to EHS policy and EHS procedures

Prepare, review & maintain API production documents (Batch Records, SOPs). Ensure cGMP compliance, collaborate with QA/QC teams, manage document control & investigate deviations. Degree in Chemistry, API documentation experience required.

The Regulatory Affairs Senior Associate role involves being responsible for the preparation, compilation, evaluation, and submission of ANDAs & Amendments to USFDA. This position also entails handling deficiencies and ensuring the timely submission of responses to the agency. Your main responsibilities will include coordinating with cross-functional teams and stakeholders such as R&D, Quality, manufacturing, SCM, IP, and PM, along with vendors when necessary. You will be tasked with evaluating documents in accordance with current regulatory requirements. Additionally, you will need to review various documents including Product Development Reports, Batch Records, Specifications, Analytical Pr...

The job responsibilities for this role include establishing and maintaining a comprehensive document control system for all manufacturing processes, which includes batch records, standard operating procedures (SOPs), and quality control documentation. It is essential to ensure that all documentation adheres to relevant regulatory requirements, industry standards, and Good Manufacturing Practices (GMP) specifically for Ayurvedic products. Keeping abreast of any changes in regulations and updating documentation accordingly is a key aspect of this role. Additionally, compiling and reviewing batch records, as well as conducting regular audits of documentation for accuracy and completeness, are i...

Monitor compliance with GLP, GMP or other applicable standards. Maintain and update SOPs (Standard Operating Procedures). Review laboratory notebooks, worksheets, and analytical reports. Assist in internal and external audits. Ensure accurate documentation of QA activities and laboratory testing. Review COAs (Certificates of Analysis) and batch records. Manage deviation reports, CAPAs, and change control processes. Assist in the qualification/validation of equipment, methods, and software. Ensure timely calibration and maintenance of lab instruments.

Role & responsibilities The individual should be documenting Annual Product Quality Review (APQR): Collection of process and quality data for all products. The individual is capable for management of Retain Samples: Storage, maintain, visual inspection & destruction of Retain samples of all FG samples. Management of central document room/Documents: Issuance, Retrieval, Destruction & Control of all the GMP documents (eg: facility documents, Batch records, Protocols, Reports, etc.) Key competencies Skill Required/ Tools/ Software: The individual is responsible to work in compliant with Good Documentation Practice (GDP) and current Good Manufacturing Practice (cGMP). Interpersonal Skill: The in...

Technology Transfer professional to support seamless scale-up and integration of new products/processes from the production floor. The role bridges development and manufacturing, ensuring process understanding, compliance, and efficiency.

Position : Section Head - Batch Release QA Functional Area: QA Reports to: QA Head Grade: G9B Department: Quality Location: Halol (OSD) POSITION SUMMARY Responsible for IPQA activity and strategy in line with Sun Pharma Compliance, Product Quality Management objectives and Regulatory requirements. Responsible for planning and arranging for internal and external departmental support of quality assurance activities as directed in approved protocols, quality systems or Procedures. Identify and implement solution for improving existing site quality assurance systems and processes Involvement in co-ordination of activities for software like SAP HANA at plant Responsible for review and Approval of...