6 Batch Release Jobs

Retrival& Issuance of documentation GDP CGMP Control Documents Dispatch verification Batch Manufacturing

Vibonum Technologies, Bangalore is hring: Executive - AQA/QMS/DOC Cell Executive - IPQA/QMS Role & responsibilities Review and release the Finished products/Raw materials/ stability samples after the analysis in line with defined procedures. Review and approval of Qualification, validation documents, protocol, and reports. Initiation and / or Review and approval of QMS elements like Change controls, deviations, Out of Specifications, Out of Trends CAPA, etc. Management of Document cell (Issuance, retrieval archival and destruction of documents) to avoid any unauthorized access and usage of documents. Conduct training for newly joined Employee and existing employee and evaluate the effectiveness of the procedure. Review of batch documentation (BMRs, BPRs, COAs etc) manufactured and compilation of a complete set of batch documents required for batch release Perform the other activities assigned by the department Head. Preferred candidate profile Well-versed with OSD Manufacturing and Packing activities Sharp in Documentation and Review of shopfloor data Good communication and interpersonal skills EU/ TGA/ ANVISA regulatory audit exposure is an advantage Good knowledge of European agency guidelines Sound knowledge of ALCOA+ concepts and able to identify gaps w.r.t. ALCOA+ principles if any at shopfloor operations. Knowledge of the local language (Kannada) is an added advantage Perks and benefits: Best in the industry. Early joiining will first prference.

Seeking a IPQA Executive to ensure skincare products meet regulatory, safety & quality standards. Work closely with manufacturing, R&D, and QC teams. Requirement: 2+ years of QA experience, preferably in cosmetics or pharma manufacturing. Required Candidate profile Skincare manufacturing & QC expertise Knowledge of FDA, GMP, ISO regulations Attention to detail & procedural compliance Strong analytical, problem-solving & com skills Ability to work with GMP proces

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.

"Hiring Event Announcement" We are organizing a Hiring Event in Hyderabad on April 6th, 2025, for our Quality, Production and operation team of Baxter Injectable Manufacturing, Ahmedabad site. Register now for open positions mentioned below. The registration window opens until 4th April 2025. Engineering, Utility (BE/B.Tech or Diploma Electrical): 4 to 8 years experience in Injectable manufacturing plant with Utility maintenance-electrical site plant maintenance activity Engineering, Technical (BE/B.Tech or Diploma Mechanical): 4 to 8 years experience in an Injectable manufacturing plant with plant machine maintenance, preventive maintenance and breakdown maintenance activity Engineering, Instrumentation/Lab maintenance (BE/B.Tech or Diploma Instrumentation): 4 to 8 years experience in Injectable manufacturing plant with Lab maintenance, calibration, validation, Instrumentation, etc,. activity QA Batch Release (M.Pharm/M.Sc/B.Pharm /B.Sc) : 4 to 8 years experience in QA batch release, Batch record review, release document preparation, release-related compliance and cross-functional team coordination for release activity QA QMS (M.Pharm/M.Sc/B.Pharm /B.Sc) : 3 to 8 years experience in QA QMS team with handling of QMS element, CAPA, deviation, investigation, audit compliance, risk assessment, etc., activity QA Doc Cell (M.Pharm/M.Sc/B.Pharm /B.Sc) : 3 to 7 years experience in QA doc control, Batch record review, document-SOP-log book issuance and retrieval, IRA & annual product review report update, etc,. QA Validation (M.Pharm/M.Sc/B.Pharm /B.Sc) : 3 to 7 years experience in QA validation, thermal validation, Plant machine qualification, utility, process validation, cleaning validation, and facility qualification, QMS, etc,. QA IPQA (M.Pharm/M.Sc/B.Pharm /B.Sc) : 3 to 7 years experience in QA IPQA, line clearance, sampling, Batch record review, in-process quality check, QMS, batch release, etc,. QA IPQAshiftingn chargee (M.Pharm/M.Sc/B.Pharm /B.Sc) : 8 to12 years experience in QA IPQA, shift management, manpower management, QMS, line clearance, sampling, Batch record review, in-process quality check, QMS, batch release, etc,. Micro lab QMS (M.Sc/B.Sc – Microbiology/Biotechnology) : 7 to 12 years experience of micro LAB investigation – OOS, OOT, handling Deviation and CAPA, support in Audit response, SOP preparation, Etc., Micro lab reviewer (M.Sc/B.Sc – Microbiology/Biotechnology) : 7 to 12 Experience in analysis and review of Microbial analysis (BET, MLT, Sterility., etc), Validation of Microbiological analysis (Method validation), good knowledge of LIMS or similar software, prefer the experience of writing lab Investigation MFG QMS (Investigation)(M.Pharm/M.Sc/B.Pharm /B.Sc): 6 to 12 Experience in QA QMS team with expertise in handling of investigation, shop floor compliance, QMS elements, CAPA, deviation, investigation, audit compliance, risk assessment, etc., activity MFG Production (M.Pharm/M.Sc/B.Pharm /B.Sc): 3 to 8 Experience in Injectable production, mixing(batch manufacturing), filling, dispensing, sterilization, autoclave, batch record review etc., activity MFG Packing (M.Pharm/M.Sc/B.Pharm /B.Sc): 3 to 8 Experience in Injectable packing activity. automatic visual inspection machine operation, kit preparation, VIT operator training & qualification, batch record review, etc., activity Date & Time : 6th April 2025 || 09 AM to 2 PM IST Venue : Radisson Hyderabad Hitec City, Hyderabad Registration Link copy : https://talentcommunity.baxter.com/flows/india-ptqmwtvye EEO (Equal Employment Opportunity) This is where Baxter International Inc. is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status, or any other legally protected characteristic.

Role & responsibilities Job Purpose (State in one sentence the overall objective of the job) To ensure quality standards are followed for batch releases of imported products as per the local FDA, Schedule-M and Sandoz policies. To ensure timely batch releases. To ensure warehouses operations are effectively maintained for Quality Oversight. To ensure the adherence of TP to GMP requirement as per Sandoz policy & local FDA guidelines. Major Accountabilities (Describe the main results of the job to be achieved ) Release the batch in SHAPE & communicate to CWH inline with SOP. To prepare Audit Plan and Management of Self Inspection. To support Quality Escalation Management To Support Transport Assessment and Validations Warehouse QA Oversight and Quality Management To Support Complaint Management, Deviation and Action management. QM/GOP/SOP Implementation and Maintenance To Support Quality agreement preparation and review. To Keep warehouse in regulatory compliance Document and Data Management. To Support Quality Risk Assessment for Country organization To Support management Reporting To Support Product recalls. To support change control Evaluation and approvals Key Performance Indicators (Indicate how performance will be measured: indicators, activities) Overdue records and Actions NMT 5. Quality Risk Assessment Performance for Site. No. of Batch releases within target timelines No. of Recalls. QM/GOP/SOP Implementation Score NLT 95 % COMPANY : SANDOZ Exact Work Location : Sandoz Private Limited, 6th Floor, ithink Lodha business Park, Behind Viviana Mall, Chirak Nagar, Thane, Mumbai Shift timings : General 9.00 am to 5.00 pm Contract Tenure : 9 months Will Contract Extends : Extendable up to 3-6 Month Is any Transport provided from Sandoz : Candidate can avail Company transportation from Thane Railway station to office ( Predefined timings as per company) SHARE RESUMES TO NEDUNURI.SAIKUMAR@MANPOWER.CO.IN