31 Batch Release Jobs - Page 2

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.

Vibonum Technologies Private Limited conducting a Walk-in interview in Quality Assurance department for its OSD Plant at Nanjangud, Mysore. Kindly carry your, latest 3 Months salary slip, appointment letter with CTC breakup and previous company relieving letters. ----------------------------------------------------------------------------------------------------------- Open vacancies in Quality Assurance for: IPQA Manufacturing : Exe > 08-10 Yrs IPQA Packing & Warehouse : Exp > 8 - 16 Yrs QMS: Exe / Sr. Exe : Exp > 08-10 Yrs CSV / ITQA/ Electronic DI compliance : Exp > 10-12 Yrs Process Validation : Exp > 08-10 Yrs AQA / Lab QA : Exp > 08-10 Yrs Documentation Cell : Exp > 04-08 Yrs AM/DM/Manager - Batch Release : Exp > 10-16 Yrs Vendor Audits (AM/DM) : Exp > 10-14 Yrs APQR Preparation : Exp > 04-08 Yrs Engineering QA : Exp > 08-10 Yrs Audit & Compliance/ DI Cell : Exp > 08-10 Yrs Freshers (M. Pharm/ M.Sc.) : Exp > 00-02 Yrs --------------------------------------------------------------------------------------------------------- Work Location: Nanjangud Mysore Walk-in interview address: Sai Vishram Business Hotel, Hebbagodi, 144-C/1, Kirloskar Road, opp. MTR, Bommasandra Industrial Area, Bommasandra, Bengaluru, Karnataka 560099 -------------------------------------------------------------------------------------------------------- Sai Vishram, Google location: https://maps.app.goo.gl/39MRn9XBuUQBH1yz7

Documentation Management Creation, revision, upgradation, and review of SOPs, protocols, and reports. ERP Management – Updating, modifying, and approving ERP entries for QA processes. Validation & Qualification – Execution and review of validation and qualification activities. Calibration & Mapping – Ensuring timely calibration and mapping of instruments and equipment. Quality Management System (QMS) – Handling deviations, investigations, CAPA, and change control. In-Process Quality Assurance (IPQA) – Performing line clearance, sampling, and dispensing checks. Audit Management – Planning, execution, and ensuring compliance for internal and external audits. Sample Management – Stability and retention sample handling and documentation. Training – Conducting and recording GMP and SOP training for team members. Manpower Handling – Supervising, guiding, and managing QA team activities. Annual Product Quality Review (APQR) – Preparation, review, and timely submission. Batch Release – Review of batch manufacturing and packing records for product release. Coordination – Liaising with QA Head Office and cross-functional teams for quality-related matters.

Role & responsibilities Review of the executed manufacturing documentation at contractual partners and ensure its compliance with internal Quality Management System and applicable Regulatory Guidelines in cooperation with Quality Management at Krka. Reviewing the manufacturing documentation of pharmaceutical products and identifying potential errors or irregularities. Participates in investigation of deviations, complaints, unfavorable trends, and OOS results with contractual manufacturers. Participate in harmonization of applicable change controls. Takes part in organizing audits of our contractual partners in line with the audit plan and monitors its realization. Monitors the manufacturing/control processes at suppliers/contractors. Cooperates in reviewing annual Product Quality Review reports for products manufactured for Krka as per contract. Follows Indian legislation related to production of intermediates, active ingredients and finished products, and makes a comparison with the legislation of target markets. Acts in accordance with guidelines and instructions from Quality Management at Krka. Implements legislation requirements specific for the area of work. Manages documentation from their area of work. Follows trends, implements measures and prepares periodical reports for the area of work. Other tasks delegated by Krka Quality Management in accordance with employee's qualifications and the needs of the working process. Responsibilities for correct, professional and timely performance of tasks; for complying with legislation that applies for the manufacture of pharmaceuticals and active ingredients; for quality and timely preparation of reports; Knowledge required: - General knowledge of regulatory requirements and standards in the pharmaceutical industry for EU - Good knowledge of pharmaceutical manufacturing procedures and good manufacturing practice. - Knowledge regarding handling of deviation, complaints and changes - Good communication skills for effective collaboration with other team members and contract manufacturers - Reliability and accuracy when reviewing documentation. - Proficiency in English language - ISO 9001 standard;