842 Capa Jobs - Page 13

Role Purpose The purpose of this role is to conduct audits to ensure quality compliance within the account. Do Conduct process quality audits as per plan Conduct various process audits (1 audit/ agent/ week) as per procedure and guidelines For agents identified in the bottom quartile of performance, conduct 3 audits/ agent/ week Prepare findings from the report and share it with the client and the account leadership on daily/ weekly/ monthly, as required Conduct weekly analysis to identify the error trends and for top 2 errors, conduct root cause analysis (RCA) Conduct calibration communication to communicate any changes from the client and conduct refresher trainings to bridge any skill gap due to these changes. Deliver No.Performance ParameterMeasure1.AuditAdherence to the calendar; audit targets Compliance % as per audit reports zero misses2.Process ComplianceCase targets 2 hours/ week logged to be updated with the process Mandatory Skills: L&P Policy Acquisition & Servicing. Experience1-3 Years.

To conduct preventive maintenance as per defined checklist. To carry out RCA for repetitive breakdowns. To carry out breakdown maintenance of the plant equipment. To undertake spares management.

Walk-in at Matoda Were currently recruiting for multiple positions at our SANAND manufacturing facility. If any role aligns with your experience, please bring your updated resume and walk in during the scheduled drive. Please find our current job requirements and venue details mentioned. Requirement : Injectable Manufacturing & Visual Inspection Aseptic operations/ QMS / SKID / Multi-vessel / SVP / Visual Inspector (Senior Officer / Officer / Associate) Experience - 01 to 05 Years Qualification - B. Pharmacy/ M Pharmacy / Msc /Bsc / Diploma / ITI Time and Venue : 12th June 2025, 09:30 Hrs to 14:00 Hrs SATURDAY ______________________________________________________ INTAS, Matoda facility Plot No. 457, 458 Sarkhej Bavla Highway, Matoda Village, Sanand, Taluka, Ahmedabad, Gujarat 382210 ______________________________________________________ We would be pleased if you forward or refer any of your colleagues matching the desired job roles. *Having relevant qualification only can attend the scheduled walk-in.

Walk-in at Matoda Were currently recruiting for multiple positions at our SANAND manufacturing facility. If any role aligns with your experience, please bring your updated resume and walk in during the scheduled drive. Please find our current job requirements and venue details mentioned. Requirement : Injectable Manufacturing & Visual Inspection Aseptic operations/ QMS / SKID / Multi-vessel / SVP / Visual Inspector (Senior Officer / Officer / Associate) Experience - 01 to 05 Years Qualification - B. Pharmacy/ M Pharmacy / Msc /Bsc / Diploma / ITI Time and Venue : 12th JULY 2025, 09:30 Hrs to 14:00 Hrs SATURDAY ______________________________________________________ INTAS, Matoda facility Plot No. 457, 458 Sarkhej Bavla Highway, Matoda Village, Sanand, Taluka, Ahmedabad, Gujarat 382210 ______________________________________________________ We would be pleased if you forward or refer any of your colleagues matching the desired job roles. *Having relevant qualification only can attend the scheduled walk-in.

Role & responsibilities Knowledge of ISO standards 13485, 9001, 14001 & 45001. Preparing documents, policies & procedures related to safety Conducting internal audits as per the IMS standards and ISO 13485. Knowledge of Hazard Identification & Risk Assessment and Environmental Aspects & Impacts. Investigation of Accidents / Incidents and prepare the root cause analysis reports with required CAPA. To provide regular trainings as per the training calendar. To conduct regular inspection of tools & equipment. To conduct plant visit on daily basis and communicate the hazards to the concerned departments. To conduct HSE initiatives and involve all the staffs and workers To ensure the safety practices are in line with the Factories Act 1948 To prepare JSA and carry out risk assessment To ensure the Emergency Response Plan is as per the standard requirements and is in place. Inspection of Fire Hydrant system and ensure it is in working. Knowledge of system audits, statutory and customer audits and experience of handling the audits. Responsible for HO and all plants. Minimum Qualifications: BE Mechanical / Electrical ADIS Course from MSBTE / PDIS / DIS NEBOSH IGC Preferred.

Responsible for all quality check and assurance of income row wood, in process and final. Take care of all documentations for ISO Audit, Customer and vendor Audit, Mis , Daily reports. Good knowledge of modular wood door and accessories, Fitting etc Required Candidate profile Experience: 2+ Years in Modular wood door/window/ furniture Qualification: B. Tech or Any technical degree Knowledge on ISO 9001, 14001 & 45001 Management Systems Internal Auditing

Handle quality control activities on the assembly line of electrical items Perform testing of various electrical items as per required standards Apply knowledge of CAPA and PAPA for quality improvement (added advantage) Communicate effectively with team members and stakeholders

Role & responsibilities: Inspection schedule as per client call. Inspection of products as per AQL 1.0 & IS 2500-2000. Inspection check sheet & Tech specs will be provided by client. Checking the products as per drawing (Aesthetics & Dimensional) Making separate reports for different supplier. Bi-Annually audit of respected supplierss Taking CAPA reports of rejections found during inspections from supplierss Making good behaviour between suppliers & clients. Process knowledge like plating, lacquering & powder coating. Auditing exposure like vendor audit, 5s audit, product audit, process audit. Knowledge about quality control plan. Awareness about raw material standards. Knowledge about 8D, CAPA report. 7QC tools. Quality, QA & QC knowledge. Calibration activity and its documentation. Instruments knowledge & their LC.

Skill required: Membership - Life Sciences Regulatory Operations Designation: Health Operations New Associate Qualifications: Any Graduation Years of Experience: 0 to 1 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do Embedding digital transformation in healthcare operations end-to-end, driving superior outcomes and value realization today, and enabling streamlined operations to serve the emerging health care market of tomorrowYou will be a part of the Healthcare Management team which is responsible for the administration of hospitals, outpatient clinics, hospices, and other healthcare facilities. This includes day to day operations, department activities, medical and health services, budgeting and rating, research and education, policies and procedures, quality assurance, patient services, and public relationsCoordinate the essential documentation and resources required for the filing of global applications. Understand, manage & process electronic submissions that include original application filings, Life Cycle Management submissions such as CMC, Ad-promos, amendments, annual reports, SPL submissions, etc. What are we looking for Adaptable and flexibleResults orientationWritten and verbal communicationCommitment to qualityProcess-orientation Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your primary interaction is within your own team and your direct supervisor In this role you will be given detailed instructions on all tasks The decisions that you make impact your own work and are closely supervised You will be an individual contributor as a part of a team with a predetermined, narrow scope of work Please note that this role may require you to work in rotational shifts Qualification Any Graduation

Skill required: Regulatory Services - Life Sciences Regulatory Affairs Designation: LifeScience Regulatory Svs Sr Analyst Qualifications: Bachelor of Pharmacy/Master of Pharmacy Years of Experience: 5 to 8 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The incumbent will perform the regulatory operations tasks of bookmarking and hyper linking for granular components (documents) of submission in accordance with ICH guidelines and other Health Authorities, review and transform Source Documents. Perform Quality Control (Document QC) checks for all submission components.Collect, collate and evaluate the scientific data gathered as part of R & D. Advise on legal and scientific restraints and requirements. Ensure the organization`s products comply with current regulations. Example; Build regulatory submission strategy, author CMC documents, and health authority packages etc. What are we looking for Adaptable and flexibleCommitment to qualityHands-on experience with trouble-shootingAgility for quick learningAbility to work well in a team Roles and Responsibilities: In this role you are required to do analysis and solving of increasingly complex problems Your day to day interactions are with peers within Accenture You are likely to have some interaction with clients and/or Accenture management You will be given minimal instruction on daily work/tasks and a moderate level of instruction on new assignments Decisions that are made by you impact your own work and may impact the work of others In this role you would be an individual contributor and/or oversee a small work effort and/or team Please note that this role may require you to work in rotational shifts Qualification Bachelor of Pharmacy,Master of Pharmacy

Standard Operating Procedure (SOP) for Field Quality Executive Objectives To define the standard procedures and responsibilities of a Field Quality Executive in ensuring product and process quality compliance at field locations, including customer sites, distribution points, and service areas. Scope The scope of the Quality Executive includes overseeing & inspections or assessments are required the management of cold rooms and deep freezers, maintaining push carts, and collaborating with other departments to optimize operational efficiency and quality compliance. Covers tasks from product verification, defect analysis, customer feedback resolution, and reporting. Responsibilities Field Quality Executive, Procedure Daily Planning Review inspection schedules and customer visit plans. Coordinate with field service teams. Ensure availability of required the test equipment, and documentation (e.g. Scissors, Tape roll, Temperature thermometer & Log Sheets. On-Site Inspection Verify conditions of the vehicles, handling, and usage practices. Inspect product quality and packaging integrity. Check compliance against SOPs, product specifications, and customer expectations. Record findings with photographic evidence and data logs from process improvement point of view. Customer Complaint Handling Visit the site within defined response time. Gather complaint details and inspect the product in question. Conduct root cause analysis (RCA). Provide immediate resolution where applicable, otherwise, escalate to concerned with senior management. Non-Conformity Reporting Fill out Non-Conformance Report (NCR) with complete details. Submit report to Head of the Quality Assurance & Head of the Sales department. Documentation and Reporting Maintain daily reports of site visits, issues observed, and actions taken. Submit daily summaries report to the Head of the Quality Assurance & Head of the Sales department. Document feedback and improvement suggestions from the field. Training & Communication Train field teams or vendors / Distributors on basic quality requirements of product checks and handling. Share recurring issue trends and giving solutions with internal teams. Participate in regular review & updation. Field operation Concerns- Cold Room Standards Ensure, when a vehicle arrives at any depot, unloading must take place in a designated ante room, not in open areas. Material must be transferred to the cold room immediately after unloading, without any delay. Ensure the Product Temperature maintains a temperature of -18C or below. The cold room must be free from unhygienic conditions. All crates should be positioned at least 1.5 feet away from the walls. Stacking crates should not exceed the height of the cooling unit to ensure proper air circulation around all products. Limit the number of times the cold room door is opened and ensure it closes promptly to maintain temperature. Install air curtains at the entrance to reduce temperature loss when doors are opened. Deep Freezer Standards The area around deep freezers must be clean, with no dirt or debris. Avoid overloading deep freezers, as this can prevent them from maintaining the correct temperature, leading to product melting, sogginess, deformation, or other defects. There should be no ice formation within the deep freezer. Deep freezers should be cleaned and defrosted regularly as per the maintenance schedule. Train staff to load and unload materials quickly to minimize exposure time. Ensure there is no ice formation on the push carts. Records: Inspection Checklist for Field by Quality Executive

Greetings! We are looking for a highly motivated and detail-oriented Sr. Quality Engineer professional to join our QAD team. In this role, you will play a critical part in ensuring the quality and compliance of manufacturing processes, components, and final products across various projects. As an experienced Sr. quality engineer, you will be responsible for overseeing inspection activities, analyzing quality data, driving root cause analysis, and implementing corrective and preventive actions. You will also support the development and maintenance of quality documentation, procedures, and control plans to ensure adherence to industry standards, especially in the automotive and aerospace sectors. Youll have the opportunity to work closely with cross-functional teams including design, production, and supplier quality, contributing to continuous improvement initiatives and quality assurance strategies. Main/ Essential Task : Review and close rejection/rework cases daily; ensure documentation and approvals. Analyze major defects; coordinate action plans with cross-functional teams. Review setup approvals and inspection reports to ensure product compliance. Handle customer complaints with 8D reports and ensure timely resolution. Coordinate with SQA on supplier-related issues and complaint closures. Track and validate corrective actions for effectiveness (internal & supplier). Maintain housekeeping and ensure proper flow of materials and documentation. Present rejection/rework summaries in MMR/MRM reviews. Ensure availability of gauges, instruments, SOPs, WIs, and drawings at all workstations. Monitor adherence to process SOPs and quality standards. Plan daily/weekly shift allocations and manage manpower effectively. Conduct inspector skill assessments; plan and execute training needs. Skills Required : APQP, PPAP, FMEA, SPC & MSA. Internal Auditor for IATF16949/AS9100/ISO9001 VSM, 5S & Kaizen. 8D, CAPA Process Optimization & Improvement Data Analysis & Waste Reduction Supplier Development Audit Management - Process, Customer, Certification & Vendor Working location : Dobaspete, Bangalore Interested candidate can WhatsApp their resume to 9742708222.

Role & responsibilities Strategic Responsibilities: Define and govern the corporate CSV strategy across all units/sites for GxP systems, including SAP HANA. Lead enterprise-wide validation projects ensuring alignment with GAMP 5 , 21 CFR Part 11 , EU Annex 11 , and global data integrity expectations. Establish and monitor corporate SOPs, templates, and risk-based approaches for computer system validation. SAP HANA Specific Responsibilities: Lead validation of SAP S/4HANA (MM, QM, PP, and Z-reports, workflows, GRN process) across GxP operations. Prepare and maintain validation documentation including URS, Functional Specs, Test Scripts (IQ/OQ/PQ), RTM, and final reports for SAP HANA modules. Coordinate with IT, SAP consultants, and business users to ensure change management, role-based access control(RBAC), audit trail configuration, and secure workflows. Evaluate SAP-integrated systems (e.g.,LIMS, QMS, DMS) and their GxP compliance status. Cross-System & Governance Responsibilities: Ensure centralized control and compliance of all validated GxP systems across manufacturing, QC, QA, warehouse, and R&D operations. Conduct CSV risk assessments, gap analyses , and ensure mitigation plans are implemented across systems. Support system onboarding, upgrades, and infrastructure changes from a validation standpoint. Lead or support regulatory inspections and customer audits as CSV SME. Develop and lead training programs on computer system validation, data integrity, and regulatory compliance. Manage a team or act as a corporate mentor for site-level CSV resources. Preferred candidate profile: Technical Competencies: Strong knowledge of: SAP HANA MM, QM, PP, GRN workflows, custom Z-reports GAMP 5 / V-model SDLC / Agile methodologies 21 CFR Part 11 / EU Annex 11 / WHO / PIC/S data integrity guidance Soft Skills & Corporate Traits: Strong leadership and coordination skills for multi-site operations Excellent documentation, audit readiness, and training capabilities Capability to represent the organization in global audits and customer discussions Strong cross-functional communication with IT, QA, QC, Regulatory, and external vendors

Awareness & participate in QMS External (e.g. IATF 16949) Paint Shop & Process Audits Engagement & Handling of Shifts as per process requirements. Awareness of Paint Shop process .Awareness of 5 core tools CAPA & other basic analysis tools awareness.

Handling Quality Inspection, inward Quality, incoming / sampling inspection, SMT process,knowledge about CAPA, 8D reports, 7QC tool, supplier quality, SAP knowledge, , component knowledge, sampling plan, report analysis, supplier rating/evaluation Required Candidate profile Knowledge of electronic components,electrical network, Wave soldering process, ISO/Supplier audit handling, component packing, technical documents, internal calibration, sampling insection process

Role & responsibilities: 1. Ensure compliance with Food Safety, Quality, Hygiene, and Regulatory/Statutory standards. 2. Foster a Quality and Food Safety culture through training and awareness initiatives. 3. Conduct Internal and Cross-Functional Audits on Food Safety, Quality, Health & Safety, and Environment. 4. Implement and monitor Good Manufacturing Practices (GMPs) and Good Hygiene Practices (GHPs). 5. Lead Food Safety Team and oversee training programs for employees and contractual staff. 6. Investigate customer complaints, perform root cause analysis, and implement corrective actions. 7. Ensure compliance with regulatory and importing country requirements. 8. Maintain documentation for Quality, Food Safety, HSE, and Social Audits. 9. Coordinate with external audit agencies and support customer audits with CAPA implementation. 10. Compile and report Quality and Food Safety incidents to management. 11. Validate Critical Control Points (CCPs) and execute management-assigned tasks effectively. Preferred candidate profile 1. Postgraduate degree in Veterinary Science, Microbiology, Food Science & Technology, or Biotechnology. 2. 10 to 15 years of experience in Quality Assurance, preferably in meat and meat product exports, poultry, fisheries, RTC/RTE, F&B, FMCG, etc. 3. Age: 30 to 40 years. 4. Expertise in Hygiene, Quality Control, Food Safety, Environmental, and OHSAS management (ISO 9001, FSSC 22000, ISO 14000, ISO 18000). 5. Desirable: Experience in Halal certification and ISO 17025:2005 (NABL) accredited labs. 6. Strong leadership in QA department operations and inter-departmental coordination. Interested candidate can send their CV on nibhosale@allana.com or mikhan@allana.com

Role & responsibilities Position: QC Engineer Injection Moulding Location: Arasur, Coimbatore Department: QA/QC Reporting To: AGM – QA/QC Manager Job Summary: The QC Engineer for Injection Moulding will be responsible for overseeing quality control processes, ensuring compliance with product specifications, and maintaining documentation and quality standards for injection moulding and assembly operations. The ideal candidate will possess a strong understanding of quality systems, injection moulding processes, and assembly operations. Key Responsibilities: 1. First Part Approval: o Conduct first part approval for injection moulding and assembly processes. o Perform root cause analysis (RCA) for defects and initiate corrective and preventive actions (CAPA). 2. Part Validation and Documentation: o Validate parts against specifications and ensure adherence to quality standards. o Maintain accurate documentation of quality processes, inspection results, and validation procedures. 3. Standard Operating Procedures (SOPs): o Develop and update SOPs for inspection criteria focusing on critical QC parameters in assembly and injection moulding. o Ensure SOPs are aligned with industry standards and company quality goals. 4. Operator Training: o Train injection moulding and assembly operators on accepted quality levels and inspection procedures. o Conduct regular quality awareness programs to foster a culture of quality excellence. 5. Quality Monitoring and Continuous Improvement: o Monitor and evaluate the performance of injection moulded and assembled parts. o Identify areas for process improvement and implement solutions to enhance product quality and efficiency. Requirements Key Skills and Qualifications: • Diploma / BE Mechanical / Plastics Engineering / CIPET • Minimum of 4 years of experience in quality control within the injection moulding and assembly industry. • Proficiency in RCA and CAPA methodologies. • Familiarity with quality management systems (ISO 9001, etc.). • Strong documentation and organizational skills. • Excellent communication and training skills. • Knowledge of critical QC parameters and inspection techniques. Personal Attributes: • Detail-oriented with a strong focus on quality. • Problem-solving mindset with the ability to work independently. • Strong interpersonal skills to collaborate effectively with cross-functional teams. Benefits Industrial standards

Executive-CQA Long Description 1. To perform and track the Vendor Qualification Compliance and review for all vendors & AVDs. 2. To review, approve, and extend the Q info for new alternate vendors. 3.To execute vendor Audits, CAPA tracking, and qualification documentation 4.To schedule and monitor the Vendor Audits 5.To work on VQ special projects in coordination with Project IT team 6.To track the project till its implementation and Go Live across all sites Competencies 1. Strategic Agility 2. Innovation & Creativity 3. Customer Centricity 4. Developing Talent 5. Result Orientation Work Experience 5 - 8 years

Executive-CQA-VQG 1. To perform and track the Vendor Qualification Compliance and review for all vendors & AVDs. 2. To review, approve, and extend the Q info for new alternate vendors. 3.To execute vendor Audits, CAPA tracking, and qualification documentation 4.To schedule and monitor the Vendor Audits 5.To work on VQ special projects in coordination with Project IT team 6.To track the project till its implementation and Go Live across all sites Competencies 1. Strategic Agility 2. Innovation & Creativity 4. Developing Talent 3. Customer Centricity 5. Result Orientation Education Masters in Chemistry Post Graduation in Pharmacy 5-8 YearsWork Experience

Work Experience 12 to 15 years of experience in Pharma Vendor Audit Management 1. To perform and track the Vendor Qualification Compliance and review for all vendors & AVDs. 2. To review, approve, and extend the Q info for new alternate vendors. 3. To execute vendor Audits, CAPA tracking, and qualification documentation 4. To schedule and monitor the Vendor Audits 5. To work on VQ special projects in coordination with Project IT team 6. To track the project till its implementation and Go Live across all sites Technical , behavioral & managerial 1. Strategic Agility 2. Innovation & Creativity 4. Developing Talent 5. Result Orientation 3. Customer Centricity Education Masters in Pharmacy Post Graduation in Science or Chemistry

Job Description Responsible for Toxicological assessment of genotoxic and nitrosamine impurities. Responsible to support the development of nitrosamine and other genotoxic impurity risk assessment and carryover limits. To support the site management team in reviewing cleaning, nitrosamine and genotoxic impurity and keep sites up to date according to current regulatory requirement /expectation. Reviewing Permissible Daily Intake, Occupational Exposure Limits, Toxicological Justification, Quality Risk Assessment document. Responsible for preparation and revision of corporate procedures like SOP related to the assessment of potential carryover or cross-contamination of genotoxic/carcinogenic impurities. Harmonization of Cleaning and validation procedures across all sites of Lupin. Work Experience 10-12 years Education Masters in Science Competencies Collaboration Customer Centricity Developing Talent Innovation & Creativity Process Excellence Result Orientation Stakeholder Management Strategic Agility

Preparation of Qualification documents: URS, DQ, FDS, Risk Assessment, IQ, OQ, PQ and Operation SOP of different equipment / instrument / utility. Initiation of change controls and CAPA related to Equipment / instrument / utility. Person should have hands on experience in qualification of autoclave, vial washer, depyrogenation tunnel, Filling Machine, capping machine, lyophilizer etc. Person should have exposure / understanding of qualification of packing equipment

Knowledge of visual inspection standards, 5 Why, & basic QC tools, Good in Excel reports. Teamwork & attention to detail. Prepared PQC summary reports. Ensured all inspection records are documented & comply with ISO quality requirements. Required Candidate profile Candidate should have at least 1 years of quality experience in the electronics sector. Coordinated with line QC & input teams to implement CAPA.

Manager - Processing (Production) Role: We are seeking a dynamic and seasoned individual responsible for overseeing day-to-day processing operations in sterile manufacturing, ensuring alignment with production schedules and regulatory standards. The role focuses on identifying process inefficiencies, leading improvement and automation projects, and collaborating with cross-functional teams to drive productivity, reduce waste, and enhance product quality. This position demands strong technical knowledge of sterile processing equipment and a proactive approach to maintaining seamless production workflows and continuous operational improvements. Location: Umarsadi (Vapi, Gujarat) Main Tasks: Manage and oversee work orders for our product lines, ensuring efficient execution of production plans to maximize machine performance. Plan and implement batch production on a product-specific basis, optimizing throughput and minimizing downtime. Collaborate with cross-functional departments to ensure uninterrupted operations and timely execution of preventive maintenance schedules. Lead initiatives to reduce market complaints, aiming to maintain a production ratio of over 20 million units per justified complaint. Review BMR for new products to be processed on syringe lines. Review and approve BMRs for new products prior to processing and verify completed BMRs for submission to Quality Assurance. Develop, review, and implement SOPs for syringe processing operations, ensuring thorough training and compliance among line operators. Monitor and enhance line yield while working to minimize rejection rates through process improvements and quality control measures. Ensure timely preparation of customer samples as per specifications, with accurate documentation in BMRs and logbooks. Oversee SAP activities related to batch processing, including data entry, reconciliation, and return of unused materials to inventory.. Ensure optimal shift-wise performance of SPRC machines, maintaining complete and accurate documentation in SAP, BMRs, and logbooks. Prioritize and coordinate the ETO process of completed batches, ensuring all related entries are updated in both BMRs and SAP. Maintain audit readiness by ensuring no critical observations in the production area through strict compliance and monitoring. Ensure NVPC records are correctly attached to the respective BMRs and submitted to QA within the designated timeline. Lead training programs for staff and operators on cleanroom protocols and enforce adherence to cGMP standards. Ensure full compliance with the most recent EHS guidelines across all production activities. Drive continuous improvement of the EHS management system through effective implementation, monitoring, and periodic review. Requirement: M.Pharm /B.Pharm /B.Sc /M.sc / BE (Chemical, Electrical, Instrumentation, Mechanical) from an accredited institution. Experience: Proven record of 12+ years in Junior Management in any Pharmaceutical industry with relevant experience in the area of Process Engineering. Competencies: Strong organizational skills and attention to detail. In-depth knowledge of sterile processing equipment: Washing Systems, Depyrogenation Tunnels, Sterilizers, Siliconization Systems. Sound understanding of cGMP, GEP, FDA/ regulatory requirements, and cleanroom operations. Strong command over lean manufacturing, root cause analysis, CAPA, and risk assessment tools. Strong leadership with proven ability to motivate and guide cross-functional teams. Skills: Proficiency in local languages and English, both written and spoken, to facilitate effective communication with employees and stakeholders. Knowledge of SAP, MS Excel, PowerPoint, etc. Strong learning agility and continuous improvement mindset. Contact: careers.hr@schott-poonawalla.com

Job Description Batch Manufacturing and Filling activity. Batch manufacturing experience of Solution, Emulsion, suspension and gel eye drop products. Preparation and review of Deviation investigation, Risk Assessment, Impact Assessment, Equivalency reports, URS and various other production related documents and monthly intervention reports. Responsible for audit preparation (Internal and regulatory) and compliance. Reconciliation of product at various stages of batch manufacturing and filling. Preparation and reviewing of SOP and compliance after implementation. QAMS related activity. Approved GMP trainer for provide training to team members. Preparation of Media fill BMR. Planning for production activities by coordinating with PPIC, PDL, Engineering, validation and QA. Work Experience 8 to 10 Years Education Graduation in Pharmacy Competencies Developing Talent Innovation & Creativity Result Orientation Strategic Agility Process Excellence Customer Centricity Collaboration Stakeholder Management