16 Batch Release Jobs

B.Sc/M.Sc. with 1–4 years in QA (API preferred). Strong in GMP, documentation, audits, and QMS. Detail-oriented, compliant, and reliable. Ready to ensure quality excellence in a world-class pharma environment. Required Candidate profile B.Sc/M.Sc. with 1–4 years’ QA experience in API. Skilled in GMP, documentation, audits, and QMS. Detail-oriented, disciplined, and committed to quality compliance. Perks and benefits GMP GLP plant |Growth |Safety |Compliance |Perks

The Quality Assurance (QA) Executive API (Bulk Drugs) role based in Savli, Gujarat requires a candidate with 2-5 years of experience and a qualification of B.Sc / M.Sc. As a QA Executive, your responsibilities will involve ensuring compliance with cGMP, ICH, and regulatory guidelines in API (bulk drug) manufacturing. You will be responsible for preparing, reviewing, and controlling SOPs, BMRs, BPRs, change controls, deviations, and CAPAs. In addition, conducting in-process checks for manufacturing and packaging activities, handling investigations for deviations, OOS/OOT results, and supporting root cause analysis are key components of this role. You will also be involved in participating in internal audits, regulatory audits (USFDA, EU, WHO, etc.), and vendor audits. Maintaining documentation for batch release, validation protocols, and quality systems, ensuring adherence to data integrity and good documentation practices (GDP), and supporting qualification and validation activities are crucial aspects of this position. Collaboration with cross-functional teams such as Production, QC, and R&D is essential for ensuring smooth operations. This is a full-time, permanent position with benefits including health insurance and Provident Fund. The work schedule is day shift with additional perks such as performance bonus and yearly bonus. The work location is in person.,

Implement & maintain quality systems in compliance with cGMP & regulatory norms.batch review, product release,change control,QA documentation,audits, manage deviations, CAPA,OOS investigations.quality metrics & APQR & regulatory inspection readiness.

You will be responsible for performing chemical and instrumentation analysis on various materials including in-process, raw materials, packing materials, intermediates, and finished products. Your primary goal will be to ensure compliance with dispatch timelines as per the monthly schedule provided by PPL. Your duties will include conducting instrumentation analysis using ICP-MS and LC-MS for the mentioned materials to meet dispatch timelines. Additionally, you will be involved in analytical method developments, validations, transfers, and verifications using ICP-MS and LC-MS/MS. You will be required to prepare and review protocols, worksheets, and reports for method developments, validations, verifications, and transfers. Allotting work to chemists within the section, calibrating instruments, maintaining documentation online, and ensuring minimum stock levels for various materials and standards will also be part of your responsibilities. Monitoring and reviewing analytical data, calibration data, and qualification data, as well as ensuring instruments are calibrated and maintained in working condition, will be crucial tasks. You will also play a key role in reducing lab incidences, implementing CAPA, and maintaining safe working conditions. Collaboration with QA, Production, PPIC, Warehouse, and TSD for smooth dispatches, as well as training employees on GLP/GMP and coordinating with external laboratories, will be essential aspects of your role. Your commitment to data integrity, timely analysis and release of batches, cost control, and adherence to safety practices will contribute to the overall success of the team. This position requires a Bachelor's degree and offers an opportunity to work with Piramal Pharma Solutions (PPS), a Contract Development and Manufacturing Organization (CDMO) known for its end-to-end development and manufacturing solutions across the drug life cycle. PPAs serves customers globally and provides a wide range of services, making it a preferred partner for innovators and generic companies.,

To perform IPQA activities at shop floor in every stage of OSD manufacturing and packing. Review of BMR & BPR. Review of all documents relating to the manufacturing, Packaging & analysis report prior to batch release. Review of documents of respective areas and logbooks for adequacy and completeness. QA overview for receipt of material from warehouse to production. IPQA of Dispensing, Manufacturing, Packaging and Dispatch activities. Review and Control of SOP’s, Specification, BPR issuance, Master Formulae and Records. Preparation & Review of process validation protocols and reports. Any job activity assigned by HOD

Responsibilities: * Ensure compliance with GMP, GLP & BPR review. * Conduct process validation, cleaning verification & change control. * Collaborate on batch manufacturing & release processes. * Prepare SOPs, BMRs & BPRs.

Quality Assurance Batch Release Organization Context Position Title: QA Batch Release Employee Name: Grade : Department: Location: Aurangabad Reports to: Quality Assurance Head Reported by: Plant Associates Job Objective To assure Quality of products Ontime BMR review and release with 100 % compliance. Primary responsibilities Strategic and planning To ensure the Plant complies to the QMS system as per the laid down guidelines. Functional Core Review of production schedule and their compliance to the specific requirements in the manufacturing of products. Ensure correct and timely issuance of batch documents. Review the completed batch documents and ensure compliance to the manufacturing process before the batch is released. Ensure timely review and release of batch manufacturing record as per GDP. Ensure traceability and reconciliation of All documents and review the same for non-compliance. Ensure proper storage of all the Batch manufacturing record in a systematic manner for easy and quick retrieval. Maintenance and Destruction of documents after its expiry period with proper record as per SOP. Support to QA Manager during the internal and external audits. To perform Usage Decision of batch in absence of QA head. Internal process Adherence to Regulatory Compliance, Compliance to GMP Audit/Process Audit, BMR review and Batch Release to meet regulatory requirements, Ensure c-GMP compliance during the entire manufacturing process. People development Training on compliance to Data Integrity. Training on the requirement of Online documentation. Key Result Areas Strengthening the review mechanism of batch records Effective review of batch records. Timely release batches as per the daily plan Compliance during Internal, external & Regulatory audits Key Interfaces Internal InterfacesExternal Interfaces All plant level functions Sales & CSR Marketing Regulatory dept Central Quality Assurance Vendors, regulatory bodies, customer auditors Competency Technical Competency T CompassLeadership Competency L CompassCompetencyLevelCompetency Level

As the Section Head - Batch Release QA at Sun Pharmaceutical Industries Ltd, located in Halol (OSD), you will be responsible for overseeing IPQA activities and developing strategies in alignment with Sun Pharma Compliance, Product Quality Management objectives, and Regulatory requirements. Your role will involve planning and coordinating internal and external departmental support for quality assurance activities as per approved protocols and quality systems. You will be tasked with identifying and implementing solutions to enhance existing site quality assurance systems and processes, as well as managing batch release functions at the site. Your key responsibilities will include ensuring compliance with regulatory requirements related to products, processes, equipment, and release procedures, managing batch release activities for commercial dispatch, reviewing and approving investigations and CAPA, executing change control and risk assessment processes, and maintaining quality metrics reports as per specified timelines. You will also be responsible for coordinating with Quality Persons (QPs) and customers from different regions for batch release, managing technical agreements, overseeing warehouse and BSR operations, and handling retain sample storage, inspection, and life cycle management. To excel in this role, you are required to possess a minimum educational qualification of M.Sc/M.Pharm/B.Pharm along with at least 15 years of work experience. It is essential to have a strong knowledge of GxPs, cGMP, and other regulatory requirements, as well as demonstrate skills in planning, prioritization, collaboration, accountability, compliance, and customer service orientation. Additional attributes such as people connect, attention to detail, emotional control, effective communication, and problem-solving capabilities will be beneficial for your success in this position. In terms of the working environment, you will be working in both normal office settings and non-aseptic manufacturing/packaging environments. You should be prepared to work in areas with moderate to loud noise levels, comply with gowning requirements for controlled non-aseptic manufacturing areas, and wear personal protective equipment as necessary to ensure safety and compliance with GMP requirements.,

We are currently seeking a Qualified Person (QP) to join a prominent pharmaceutical company situated in the Hertfordshire region. As the Qualified Person, you will play a crucial role in the organization by performing various responsibilities. Your primary duties will include conducting QP batch release activities, supporting the day-to-day functioning of the Quality Management System, and ensuring compliance with the QP Code of Practice and Eudralex Volume 4 GMP guidelines for QPs (Annex 16). Additionally, you will be responsible for undertaking routine product certification as a Qualified Person in alignment with relevant regulations and standards. Moreover, as a Qualified Person, you will contribute to the maintenance of GMP & GDP standards across all site operations. To excel in this role, you should possess a relevant degree in a scientific discipline, demonstrate proven industry experience in pharmaceutical quality assurance, and exhibit a solid understanding of GMP and GDP standards. Your expertise in these areas will be crucial in ensuring regulatory compliance and upholding quality standards within the organization. In conclusion, this position offers an exciting opportunity for a Qualified Person to make a significant impact within a leading pharmaceutical company. If you meet the specified requirements and are keen to advance your career in the STEM sectors, we encourage you to apply for this role at the earliest opportunity.,

We are looking for an experienced and detail-oriented Quality Assurance (QA) professional to oversee and maintain the quality management system and ensure compliance with statutory and customer standards. Responsibilities: Prepare and maintain all quality manuals, process documents, and standard operating procedures (SOPs). Review and approve process, quality control, maintenance manuals, and batch/lot releases. Investigate deviations, failures, non-conformances, out-of-specification results, and customer complaints; implement corrective and preventive actions (CAPA). Ensure calibration and maintenance of all instruments and test equipment used for inspection and testing. Ensure compliance with statutory and regulatory standards such as ISO and other applicable guidelines. Oversee validation of processes, analytical methods, and equipment, and review validation reports. Approve analytical reports for finished products, ensuring conformity to standards and customer specifications. Maintain proper control over the use of product labels in line with statutory requirements. Ensure proper inspection and test status of all materials in accordance with laid-down procedures. Conduct internal audits for quality systems, monitor corrective actions, and ensure closure. Conduct training programs to enhance quality awareness among staff. Desired Candidate Profile: Proven experience in quality assurance/quality control in [insert industry, e.g., pharma, FMCG, etc.]. Strong knowledge of quality management systems, ISO standards, GMP/GLP compliance. Excellent problem-solving, analytical, and communication skills. Ability to lead internal audits and drive a culture of quality compliance.

Responsibilities: * Lead QMS implementation & compliance * Ensure product quality through data review & annual product quality reviews * Conduct BMRRs, batch releases & equipment qualifications Office cab/shuttle Provident fund

Responsible for maintaining and improving the Quality Management System (QMS) in compliance with ISO 13485:2016 and Local regulatory requirements (Indian Medical Device Rule). Responsible for internal audits, CAPA, change control, document control, risk management, and management review processes. Support external audits/inspections (Notified Body, regulatory, customer). Ensure compliance with applicable regulatory requirements and support quality system documentation updates. Collaborate with cross-functional teams to ensure quality and compliance across product lifecycle stages.

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.