10 Batch Records Jobs

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 evaluating change requests to ensure consistency, relevance, GMP compliance, and clarity. Moreover, you will be involved in the review and preparation of documentation for batch release while actively supporting continuous improvement initiatives. This role is well-suited for individuals seeking a Full-time, Permanent position in a Day shift schedule. The ideal candidate should have at least 1 year of relevant work experience, although freshers are also encouraged to apply.,

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 defined protocols. Co-ordinating with external service providers to conduct the cleanroom validations as per ISO 14644. Co-ordinating with external service providers to conduct the calibration for all the equipments as per the defined frequency and keeping the reports are upto date. Co-ordinating with external service providers to conduct the thermal mapping for the incubators, stability chambers, cleanrooms & storage areas as per the defined frequency and keeping the reports are upto date. Keeping all the documents related to validation and calibration ready to face the announced & unannounced audits. Keeping all the documents related to validation and calibration ready to face the customer & regulatory audits. Approval of batch records. Plan and conduct vendor audits. Strict adherence to EHS policy and EHS procedures. Perform batch reconciliation of batch manufacturing records for finished product batch release.

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 Procedures, Validation Protocols and Reports, Certificates of Analysis, stability protocols, and reports. You will also be responsible for reviewing vendor documents related to API, Excipients, and Packing materials to ensure adequacy and compliance. Furthermore, you will be involved in the preparation, review, and compilation of ANDAs, Amendments, and Supplements in eCTD format. Collaboration with the Regulatory Operation team member for uploading submissions in eCTD software and reviewing exported submissions for submission will be part of your routine tasks. It is also essential to monitor the FDA website for any updates. To qualify for this role, you should possess a Master of Pharmacy in the Department of Pharmaceutics and have at least 3-5 years of experience in Regulatory Affairs.,

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 important tasks. Lastly, maintaining a systematic filing system for batch records and related documentation is also part of the responsibilities for this position.,

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 individual must have good communication skill with team, team-work capabilities, patience to work under pressure. Digital Skills: Effectively use MS tools, i.e., Word, Excel, PowerPoint, in day-to-day operations. If required, need to operate company software.

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 Quality management/GMP records. Responsible to ensure and perform site data review of batch records for completeness of documentation, approval and rejection of materials per current good manufacturing procedures and escalation of quality incidences, Continuous process verification (CPV). Manage the batch release function at site wrt documentation, systems, approval and rejection of materials, products at the Site per current Good Manufacturing Practices requirements. The incumbent will assure individual compliance with the all concerned regulatory requirements, GxPs and applicable department programs, including training, documentation, Standard Operating Procedures, and Sun Pharma Global Quality Policies, Standards and Procedures. Key responsibilities: 1. Ensure compliance to regulatory requirements on product, process, equipment and release procedures. 2. Manage Batch release activities for commercial dispatch. 3. Escalate compliance concern to concern stakeholder. 4. Review, compliance of BPR and batch release for commercial dispatch. 5. Review and approve the investigations, CAPA, and effectiveness checks with adherence to timeline. 6. Execute change control and risk assessment whenever required. 7. Ensure Quality Metrics, Quarterly BPR report as per specify timeline. 8. Ensure timely Batch release through electronic system. 9. Planning and arranging for internal and external departmental support of Quality Assurance activities as directed in approved protocols, quality systems or Procedures. 10. Follow the EHS policy and maintain the compliance to GMP requirements. 11.Co-ordination with QPs and customers of different region for batch release. 12.Management of Technical agreement with QP and Customers. 13.Responsible for oversight in warehouse and BSR. 14.Management of retain sample storage , inspection and life cycle management. MINIMUM EDUCATION/EXPERIENCE REQUIREMENTS M.sc / M. Pharm/ B. Pharm 15 years with work experience preferred. REQUIRED SUCCESS ATTRIBUTE Knowledge of GxPs, cGMP and other regulatory requirements. Planning and Prioritization Collaboration Accountability Compliance Customer Service orientation Secondary Success Attributes People Connect Attention to detail Emotional control Effective Communication & Problem solving WORKING ENVIRONMENT/PHYSICAL REQUIREMENTS Incumbent performs work assignments in both normal office and non-aseptic manufacturing/packaging environments. Moderate to loud noise level is common in production rooms. The incumbent must be able to comply with the gowning requirements for entry into controlled non-aseptic manufacturing areas, and wear personal protective equipment as required. This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job. This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.