33 Batch Records Jobs - Page 2

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...