43 Vendor Qualification Jobs

As a Battery Pack Design Engineer based in Bangalore, you will be an integral part of the battery pack engineering team, focusing on addressing complex structural, electrical, and thermal challenges. Your primary responsibility will involve designing and developing components and assemblies for production, testing, POC, and ensuring the safety of highly integrated batteries. Your work will have a significant impact on the product direction, pushing Pravaig to become a leader in battery technology. Your key responsibilities will include: - Demonstrating expertise in structural, electrical, thermal, and mechanical battery systems. - Utilizing strong analytical and problem-solving skills for mechanical engineering analysis. - Leading battery design and development projects, with a preference for 3-D CAD experience. - Familiarity with sensor instrumentation and data acquisition systems is advantageous. - Analyzing and managing test data from large data sets. - Applying knowledge of statistical analysis and design-of-experiment techniques. - Possessing excellent written, verbal, and presentation skills to effectively communicate with management, peers, and suppliers. - Adapting to a dynamic and fast-paced work environment. - Conducting vendor qualification for manufacturing processes. - Expertise in designing for various production processes such as injection molding, extrusion, metal stamping, die castings, sheet metal, and weldments. - Ensuring the preparation and release of all 3D data, drawings, and part specifications. Required Skills: - Strong problem-solving and analytical skills with knowledge in battery cell design and material characterizations. - Taking ownership of Battery Pack components, overseeing engineering development from concept to production. - Integrating mechanical designs with high voltage electrical systems within a multidisciplinary environment. - Proficiency in DFM, DFMEA, PFMEA, and DFA methodologies. - Ability to interpret engineering/manufacturing drawings and good knowledge of GD & T. - Familiarity with various materials used for Battery Packaging & Electric Vehicles. - Results-oriented with proven creative and critical thinking abilities. - Maintaining flexibility and composure in ambiguous and rapidly evolving situations. - Awareness of engineering standards and automotive regulations. - Comfortable with initiating and leading projects.,

Job Title : Assistant Manager Or Deputy Manager Job Location : Hyderabad Department : QA Reports to : HOD Job Objective : To perform the QA activities in view of system upgradation and improvement in the existing procedures. Job Role: 1. Execution & co-ordination for investigations, Identification of root cause along with assignment of adequate CAPAs for Returned material, Incidents, Deviation, OOS, OOT, complaints & other quality events. 2. Logging, Review & Closing of the change controls and CAPAs along with implementation of CAPA and its effectiveness verification as applicable. 3. Responsible as site representative during Regulatory Audits and customer inspections to co-ordinate with the Inspectors /Auditors. 4. Preparation & review of quality risk assessment reports of products & general systems 5. Conduct on the Job Training and cGMP trainings. 6. Implement documentation system to develop, maintain, distribute and control of all Quality Control, Quality Assurance, Production, Maintenance and Warehouse records. 7. Planning & execution of internal quality audits and perform vendor audits for the KSMs and packaging materials for vendor qualification. 8. Co-ordination with the customer for compliance and day to day issues. 9. Quality agreements review and preparation. Job Qualification: Masters in Chemistry (Any specialization) Job Experience: 10 to 12 years Desired attributes: Technical / Functional: Should have exhaustive knowledge on the drafting skills (E.g. Investigations, Responses & compliance). Should have sound command on the English with speaking and Writing. Sound knowledge of the production operations, QC analytical techniques & facility and maintenance functions. Behavioral: Team management, Leadership, Project management, Proactive, Time management and Critical thinker.

Regulatory Affairs associate with knowledge in Indian Market. Customer & Regulatory communication and responses, Vendor qualification, Tracking of changes, Preparation of DMF's, Regulatory Affairs with knowledge in Indian Market. Required Candidate profile Candidates from Pharma background only with experience in Regulatory Affairs on Indian Market.

You will be responsible for preparing, reviewing, and implementing Standard Operating Procedures of Quality Assurance, ensuring that day-to-day QA Controls are in place, and empowering QA for the entire plant. Your role will involve establishing, implementing, and maintaining the necessary processes for the Quality management system. You will adopt a document control procedure to approve, review, and update all changes to documents within the scope of the Quality Management System. Issuance of Quality Management System related formats and maintaining the log accordingly will be under your purview. You will be required to follow up on deviations, change controls, incidents, material and product destructions, Internal Audits, re-packing activities, and corrective & preventive actions with the respective departments. As part of your responsibilities, you will prepare risk assessment documents and ensure that the performance of the Quality Management System is reviewed at planned intervals to ensure its continuing suitability, adequacy, and effectiveness. It will be your duty to maintain documents as per current Good Manufacturing Practices and to intervene and call meetings to resolve QMS and GMP related queries. You will provide documents for regulatory affairs and handle regulatory queries. Co-ordination with internal department personnel as well as external parties will be essential. Additionally, you will be responsible for audit preparation, execution, and compliance, as well as handling notifications to management regarding documents. Investigating and reviewing non-conforming events, including customer complaints and internal non-conforming events, and deciding on Corrective and Preventive Actions (CAPA) will be part of your role. You will prepare, review, and implement the Master list of Standard Operating Procedures and review qualification and validation documents. Reviewing and implementing the Annual Training Plan of GMP/Technical/SOP training, coordinating with the concerned departments for execution, and maintaining training records will be crucial. You will also be responsible for verifying and implementing the Batch Numbering system and allocating Equipment identification numbers, as well as reviewing and following up on the updating of equipment/instrument lists. Managing the update/review of the approved vendor list, vendor qualification planning, and documents will also fall within your responsibilities.,

Roles and Responsibilities Ensure compliance with GLP guidelines, including investigation of OOS/OOT events and vendor qualification. Maintain accurate records of GLP documents, instruments, and equipment through preventive maintenance schedules. Conduct calibrations on instruments according to CGMP requirements and perform spares management tasks. Implement LIMS system for effective inventory control and HPLC analysis. Perform CAPA activities as needed to resolve quality issues. Desired Candidate Profile MS/M.Sc(Science) degree in Chemistry or Organic Chemistry from a recognized university. Minimum 10-15 years of experience in pharmaceutical industry with expertise in GLP practices. Strong understanding of instrument calibration procedures under cGMP regulations. Proficiency in maintaining IQ, OQ, PQ documentation for laboratory equipment.

As the Procurement Manager in the pharmaceutical and nutraceutical industry, your primary responsibility will be to oversee the sourcing, purchasing, and management of raw materials, packaging materials, and third-party services in adherence to regulatory and quality standards. Your role will entail a comprehensive understanding of Good Manufacturing Practices (GMP), vendor qualification, and supply chain risk management to ensure a continuous supply of essential materials for formulation and production processes. Your key responsibilities will include strategic sourcing by identifying and qualifying suppliers globally for APIs, excipients, nutraceutical ingredients, and packaging materials while ensuring compliance with regulatory bodies such as USFDA, FSSAI, and WHO-GMP. You will be responsible for establishing and maintaining strong supplier relationships through periodic audits and performance evaluations. Additionally, you will negotiate contracts to secure favorable terms for cost, quality, lead time, and supply continuity. Compliance and documentation will be crucial aspects of your role, requiring you to ensure adherence to regulatory and quality guidelines for all procured materials. You will be responsible for maintaining documentation for audits and inspections, including Certificates of Analysis (COAs), Material Safety Data Sheets (MSDS), Drug Master Files (DMFs), among others. Collaborating with R&D, production, and planning teams, you will forecast material requirements and optimize inventory levels to prevent stock-outs or overstocking. Cost optimization will be a primary focus, where you will drive initiatives to reduce costs while upholding material quality and integrity. Identifying potential supply chain risks and developing mitigation strategies, such as alternate suppliers and dual sourcing, will also be part of your responsibilities. You will utilize ERP systems like SAP or Oracle to manage purchase orders, supplier records, and procurement analytics, generating reports on procurement Key Performance Indicators (KPIs). To qualify for this role, you should hold a Bachelor's degree in Pharmacy, Chemistry, Life Sciences, or Supply Chain, with an MBA or PGDM in Supply Chain Management being preferred. You must possess 5-10 years of procurement experience in the pharmaceutical, nutraceutical, or related industries, along with a deep understanding of cGMP, regulatory requirements, and sourcing challenges in the pharma/nutra sector. Strong negotiation, communication, and vendor management skills are essential, as well as familiarity with ERP systems and procurement software. Preferred skills for this position include knowledge of global sourcing, import/export regulations, and supplier qualification processes. Experience in raw material planning and coordination with R&D and formulation teams would be advantageous, as would certification in procurement or supply chain (e.g., CIPS, APICS, CPSM). This is a full-time position with a day shift schedule and opportunities for performance and yearly bonuses. The work location is in person.,

Responsible for overall Quality control laboratory Implementation of cGMP and good laboratory practices. Handling of laboratory incident, Out of calibration and deviation investigation. Conducted investigations on product/material test results failures and out of trends Review & approval of standard test procedure, specification Handling of laboratory incident, Out of calibration and deviation investigation. Making sure that all deviation, OOS,OOT, incident are investigated and closed before the release of the batch/material

As an Assistant Manager EQA, you will be responsible for overseeing the vendor qualification program and ensuring compliance with regulatory standards. Your primary duties will include conducting vendor qualification and requalification activities to maintain ongoing compliance. This will involve conducting license and documentation checks to uphold the Global Supplier Bona Fide program and Distributor Chain of Custody programs. You will be tasked with preparing and executing new and existing Quality Agreements as part of the periodic review program. Your role will also involve managing the Global GMP Vendor Master/Qualification Data in SAP, including monitoring expiration dates and ensuring timely escalation and remediation of supplier compliance risks and failures within your scope. You will collaborate closely with cross-functional stakeholders for remediation purposes and work in alignment with direct line management. To excel in this role, you must demonstrate Endo Values and uphold the Endo Code of Conduct through your actions. You will engage with functional employees to ensure their compliance with GMP, Values, and Code of Conduct training. Additionally, you will actively participate in Good Catch and Continuous Improvement programs to drive excellence within the organization. The ideal candidate for this position should hold a Master's degree in Chemistry, with hands-on experience in the API industry. You should have a strong background in API Synthetic Chemistry review, as well as experience in Quality and Manufacturing processes. A minimum of 10 to 14 years of relevant experience is required to be considered for this role. Commitment to Diversity, Equity, and Inclusion is a core value that we uphold at our organization, and we expect all employees to champion these principles in their daily practices.,

Should have the experience in activities like QMS Activity, BMR Review, Change Control, Document Issuance, Vendor Qualification, Process Validation etc. Process validation / equipment Qualification protocol preparation and review Required Candidate profile Vendor qualification and validation

Role & responsibilities Vendor Qualification & Management: Evaluate, qualify, and maintain vendor/supplier compliance with applicable standards and regulatory requirements. Audit Planning & Execution: Plan, prepare, and execute various types of audits including internal, external, regulatory, and third-party audits. Ensure timely closure of audit observations. Quality Management Systems (QMS): Implement, maintain, and improve QMS practices in alignment with cGMP and global standards. Oversee documentation, deviation management, CAPA, and training programs. Regulatory Compliance: Ensure site-wide compliance with global regulatory standards such as cGMP, ICH guidelines, and ISO 9001:2015. Participate in inspections and ensure readiness. Validation Activities: Lead and support Process Validation and Cleaning Validation activities. Ensure protocol and report preparation, execution, and review are as per regulatory expectations. Equipment & Instrument Qualification: Oversee and review qualification of equipment, instruments, and systems in coordination with cross-functional teams. Risk Assessments & Change Control: Conduct risk assessments and manage change control activities with appropriate impact analysis and documentation. Desired Skills: Strong knowledge of API manufacturing QA systems Exposure to global regulatory audits (e.g., USFDA, EU, WHO) Proficient in documentation, investigation writing, and root cause analysis Excellent communication and leadership skills

Role & responsibilities To review that all relevant quality management systems of Hosur manufacturing site are implemented and well maintained. To review, monitor and improve Quality performance of Hosur manufacturing site. To promote quality attitude, awareness, and mindset of the site by all proper means including training to the cross functional team members. Implement, audit, and develop quality management system, in line with Global quality policy/ manual and procedures relevant to area. Ensure the required process controls are in place wherever they are necessary. To review that testing and inspection of all raw materials, packaging materials and finished goods are carried out as per documented testing procedures and specifications. To review that the release of all raw materials, packaging materials, bulk as per approved SOP before they are used for further production activities. To review the release process of all finished goods as per approved SOP and global requirements including GFS before they are released for distribution. To review all RM and PM used in manufacturing process are from approved suppliers and with the required quality before it reaches Hosur manufacturing site including COA verifications against the documented specifications. To review all the internal lab/ External labs are conducting the testing processes as per the documented procedures and specifications. Ensure appropriate investigation are carried out throughout the manufacturing site in case of any quality related issue and ensure the corrective and preventive actions are implemented to mitigate the identified root causes for the quality issue. Ensure the preparation of training calendar and adherence to the same. To support and conduct self-inspection quality audits across all the QMS areas and continuously improve the QMS implemented at site. To ensure that all audit points/recommendations highlighted in the audit reports are followed up and closed effectively as per the agreed timelines. Review the performance of suppliers on a regular basis. To support all key initiative at the site as key member of the site. To support the site in conducting management review meetings as per the schedule. To accept and execute other responsibilities assigned by the management time to time.

Job Summary As a qualified candidate, you will be leading the Quality Assurance, QC Chemistry and Microbiology Laboratories for the site. Your role will involve developing Standard Operating Procedures (SOPs), ensuring compliance with current Good Manufacturing Practices (cGMP) and regulatory guidelines, and monitoring day-to-day department activities. Responsibilities include reviewing and approving documents, executing in-process controls, participating in investigations, vendor qualification, stability management, and ensuring safety practices. Roles & Responsibilities You will be responsible for organizing the recruitment and training of QA (Quality Assurance) and laboratory personnel for chemistry and microbiology laboratories. You will ensure adherence to systems and procedures by all QA and laboratory personnel. You will be responsible for organizing contract laboratory audits and certification. You will formulate systems and procedures for the effective implementation of cGMP, GLP (Good Laboratory Practices), and other industry practices and regulations for the manufacture, storage, and distribution of drug products. You will plan and monitor the daily activities of different sections of the department, ensuring the availability of required facilities and materials for daily functions. You will ensure timely review and approval of all Master documents, such as SOPs, guidelines, production records, specifications, validation protocols, and other necessary reports/documents. You will be responsible for proper sampling of in-process and finished products, management of reserve and stability samples, and collection of finished products. You will oversee the execution of in-process controls and checks during manufacturing and packing. Your role includes reviewing and releasing/rejecting finished drug product batches, evaluating product recalls, monitoring quantity and disposition of recalled/returned material. You will participate in investigations, providing suitable Corrective and Preventive Actions (CAPA) to prevent recurrence. You will review, approve, and implement CAPA for incidents, change controls, Out of Specifications (OOS) and Out of Trends (OOT) observations. You will manage vendor qualification, material management, vendor audits, stability management, and field alerts as required. As a qualified trainer, you will implement training programs, ensure compliance, and provide training on cGMP and SOPs. You will ensure compliance with CAPA for deficiencies noted in self-inspections, internal audits, and external audits. Your responsibilities include preparing and approving Annual Product Quality Reviews, reporting Adverse Drug Reactions, and ensuring departmental adherence to safety practices. You will also be responsible for ensuring the safety, strength, purity, and efficacy of the product, along with any other assignments from higher management. Qualifications Educational qualification: An M. Pharm/M.Sc. with experience in Sterile products. Minimum work experience: 15 to 20 years. Skills & Attributes Technical Skills Experience in recruitment and training of QA and laboratory personnel in Chemistry and Microbiology laboratories. Experience in establishing systems and procedures for cGMP, GLP, and other industry practices. Experience in handling investigations, audits, and implementing resulting CAPAs. Skills in vendor qualification, audits, and material management. Behavioural Skills Effective leadership and organizational skills for managing laboratory personnel and operations. Detail-oriented mindset for thorough review and approval processes. Strong communication and collaboration skills for audits, investigations, and compliance activities. Commitment to safety practices and reporting Adverse Drug Reactions. Additional Information About the Department Global Manufacturing Organisation (GMO) Dr. Reddy's Laboratories is dedicated to making an impact on global healthcare through precision manufacturing and innovation. With 19 state-of-the-art manufacturing plants across multiple locations, we are a leading force in the pharmaceutical industry. Our capability to deliver quality medicines to patients in 66 countries is driven by benchmarking manufacturing processes and operational excellence. Benefits Offered At Dr. Reddy's, we prioritize your career growth and professional development through personalized learning programs. Our benefits are designed to meet industry standards, including joining & relocation support, family benefits, learning opportunities, medical coverage, and life coverage. Our Work Culture At Dr. Reddy's, our employees are guided by the principle of "Good Health Can't Wait." We see healthcare solutions as a means to help patients lead healthier lives. Our work culture fosters empathy, dynamism, and teamwork, empowering individuals to make a meaningful impact on global healthcare. Visit our career website at [Dr. Reddy's Careers](https://careers.drreddys.com/#!/) for more details.,

As a Parts Operation Quality Manager at Siemens Energy, you will leverage your proven experience in handling quality control functions for Spare Parts Operations at the manufacturing facility in Naroda. Your responsibilities will include managing both manufactured and outsourced components, demonstrating knowledge of compression products, suppliers, and customers, and ensuring adherence to quality aspects and manufacturing processes. You will independently optimize the quality control function related to spare parts operations, oversee supplier quality and parts inspection, align customer quality requirements with SE standards, and work collaboratively to achieve and enhance key performance indicators (KPIs) like on-time delivery (OTD), customer satisfaction, non-conformance costs (NCCs), first-time right product supply, shipping accuracy, etc. Additionally, you will be involved in vendor qualification/audits, quality requirement alignment with vendors, parts quality inspection processes, customer complaint coordination, technical support provision, and driving Quality Management System (QMS) certification processes. Your role will also entail coordinating with the main equipment group for quality-related requirements, inspecting parts shipped from the Parts operation warehouse, organizing third-party inspections, staying updated on industry trends, overseeing customer product repairs, addressing field quality issues, reviewing and processing nonconformances, managing quality requirements for modifications and upgrades, and aligning Client Quality Action Plans (QAP) with supplier QAP. To excel in this role, you are expected to hold a bachelor's degree in engineering, business administration, Quality Assurance/Control, or a related field, along with 5 to 7 years of relevant experience in Quality Assurance/Quality Control or a related area. Proficiency in computer skills, especially with Microsoft Office Suite, ERP software (like Oracle, SAP), and CRM systems (such as Salesforce), is beneficial. Furthermore, you should possess expertise in quality control functions, inspection of various components, knowledge of compression products, suppliers, and customers, and a structured, data-driven, and analytical approach to problem-solving. Strong communication, networking, relationship-building skills, and fluency in English are essential for effective collaboration with teams and stakeholders. Your role will contribute to the Transformation of Industry division at Siemens Energy, supporting the decarbonization of the industrial sector and sustainable energy processes. Siemens Energy values diversity and inclusion, encouraging individuals from various backgrounds to contribute to the company's success. By joining Siemens Energy, you become part of a global team dedicated to developing energy systems for a sustainable future and driving innovation in the energy sector. For more information on how you can make a difference at Siemens Energy, visit: https://www.siemens-energy.com/employeevideo Siemens Energy is committed to diversity and inclusion, creating a workplace that thrives on the unique contributions of individuals from over 130 nationalities. Employees are entitled to benefits such as medical insurance coverage and meal card options as part of the company's comprehensive rewards package.,

1. Preparation of Annual/Periodic Product Quality Review (APQR/PQR) 2. Preparation of finished product specification (Tablet, External preparations & Injection) 3. Preparation of Protocol and Reports of PROCESS VALIDATION Batches. Required Candidate profile 4. Handling of Incidents, Deviation, CCP, OOS, OOT and Material Rejections 5. Issuing BARCODES for new Registered products in coordination with regulatory 6. MARKET COMPLAINTS and CAPA.

Role & responsibilities Responsible for defining QA strategy, approach and execution in the field of document control, IPQA, qualification/validation, GLP, training activities etc. and responsible for leading and directing QA team To approve SMF, VMP, quality manual and validation protocol. To conduct internal audit / self-inspection to ensure compliance to GMP and another regulatory requirement. To arrange management review meeting and escalate the outcome of quarterly report to management. To handle the Market Complaints and to participate in Product Recall. To approve quality system documents likes Change controls proposals, Deviations, Incident reports, CAPA reports, OOS and OOT, NCR, Market Complaints, product recalls and Returned goods. Responsible for review and approval of new as well as revised related Specification, Standard Test Procedure and Analytical Work Record. Responsible to design validation/ qualification strategies Responsible for validation /qualification of processing equipments, cleaning equipments and testing equipments on time. Responsible for day-to-day validation planning and execution activity. Responsible to approve specifications, standard test procedures and analytical work records. To approve quality management system documents i.e. change controls, deviations, incident reports, out of specifications, out of trends, non-conformance reports, market complaints, product recalls, returned goods, corrective and preventive action reports. Responsible for regulatory & customer audits preparation, execution and its compliance. To approve and authorize technical agreements from customer and outside party. Responsible to coordinate with regulatory department for submission of dossiers and documents to regulatory department. Responsible to make the management aware of any deviation/non-compliance or any other quality related issues during validation/ qualification & processing. To ensure the implementation of quality risk management procedures. Responsible to finalize training topics as per requirement and organize annual training plan with Training coordinator on cGMP and technical aspects. To ensure that processes needed for the Quality Management System are established, implemented and maintained. Responsible for investigation & review of non-conforming events including customer complaints and internal non-conforming events. Responsible for report, review, evaluation and tracking of change control, deviation, incident, market complaint, non-conformance report, product recall, corrective and preventive action. Responsible to ensure that a document control procedure is adopted to approve, review and update all changes to critical documents within the scope of Quality Management System. Responsible to perform vendor audits and internal audits. To check audit trial and back-up verification documents. Participation in study raised through Quality Management System.

The Procurement Engineer is responsible for conducting procurement activities with both local and foreign vendors in adherence to the company's procedures, code of ethics, local content regulations, and QHSE policy. This includes managing procurement processes for mechanical equipment and package items such as Raw gas Compressors, Dehydration units, Gas Sweetening systems, Chiller units, Air Coolers, Pumps, Heat Exchangers, Vessels, Tanks, OH cranes, Chemical Injection Skids, and more. You will be required to request commercial offers, align material requests with supplier proposals, coordinate with the technical department to resolve any discrepancies, evaluate commercial offers, negotiate agreements with vendors, and ensure the quality of materials aligns with technical specifications and relevant certifications. Additionally, you will prepare procurement status reports, resolve delivery bottlenecks, and obtain necessary approvals before issuing Purchase Orders (POs). The Procurement Engineer must maintain detailed documentation, including Commercial Bid Evaluations (CBE), Technical Bid Evaluations (TBE), Frame contracts, and purchase agreements with vendors. You will need strong contract management skills, the ability to coordinate with project teams across different locations, and ensure timely delivery of materials as per agreements. Furthermore, you will be responsible for archiving purchase orders, contracts, cost status, supplier qualification records, and other relevant documents in the procurement database. You should actively participate in inspection activities for high-value materials and inform the warehouse in advance for proper arrangement of unloading and storage. The Procurement Engineer must adhere to internal working schedules, close Non-Conformance Reports (NCR) within the specified deadlines, update the Local Content database for each purchase order, monitor and support expediting activities, and participate in vendor qualification and assessment. To qualify for this role, you should hold a Bachelor's degree in Mechanical Engineering, Chemical Engineering, Petrochemical Engineering, or a related field, with a minimum of 8+ years of experience in procurement management within the oil and gas industry. Strong organizational, communication, and analytical skills are essential, along with proficiency in English, and knowledge of Kazakh or Russian would be beneficial. Proficiency in Microsoft Office tools is required, and the ability to interpret contracts, build strong relationships, and work effectively both independently and as part of a team is crucial. In summary, the Procurement Engineer plays a vital role in managing procurement activities, ensuring compliance with regulations, and maintaining efficient supply chain operations within the oil and gas industry.,

SBM Offshore is seeking a detail-oriented individual to join our Project Management team in Bangalore, IN. As part of our team, you will play a crucial role in supporting the Category Manager in managing strategically important suppliers and sourcing key external workers globally. Your responsibilities will include analyzing spend related to the category, leading vendor qualification activities, negotiating and contractualizing agreements with suppliers, and developing long-term relationships with strategic suppliers. Key Responsibilities: - **Strategy:** Assist the Category Manager in managing suppliers and sourcing external workers efficiently. Collect and analyze spend related to the category. - **Supplier Qualification:** Lead vendor qualification activities for strategic vendors in your category. Negotiate and contractualize Frame Agreements with T2 and T1 suppliers. - **Supplier Management:** Develop long-term relationships with strategic suppliers. Provide input to Category Manager for market analysis and support Project & Operations teams in vendor relationships. - **Supplier Performance:** Monitor Category Agreement performance and ensure best practices are implemented for continuous improvement. Job Requirements: - **Academic:** Any Graduate with 4 to 7 years of work experience. - **Experience:** Familiar with procurement administration, purchasing systems, and purchasing regulations. Proficiency in IFS (AMOS & NADIA) and MS applications. Fluent in English and willing to travel internationally including offshore. - **Behaviours & Interpersonal Skills:** Knowledge of external workforce, service contracts, labor laws, and regulations. Soft skills and ability to work collaboratively with stakeholders. If you are a motivated professional with a background in procurement and a passion for sustainable energy solutions, we invite you to join our team at SBM Offshore. Learn more about our company and the opportunities we offer at www.sbmoffshore.com.,

We have an opening for one of our prestigious product based company Experience: 3 to 6 Years Budget: upto 15 LPA (As per exp range) Location: Pune, Maharastra Notice: Immediate to 15 days Work Mode: Work from office Must Have: Should be proper documents Skills: Siemens opcenter, Quality management, Defect Tracking, Inspection, Vendor Qualification, QM Process, SAP Interfaces Job Description IT Consultant CAQ Systems (Opcenter Quality) Together we make the difference Siemens Mobility is an independent managed company of Siemens AG. Its core business includes rail vehicles, rail automation and electrification solutions, turnkey systems, intelligent road traffic technology and related services. The Information Technology (IT) department has the global responsibility for the internal IT of Siemens Mobility. Its goal is to provide a robust and efficient IT landscape derived from business and market demands. Your personality and individuality make the difference. In our team, we increase business performance and point the way into the digital age. Is that exactly your thing? Then live your passion in a cross-location team in which you can actively shape the future of our company. You open up new possibilities for our customers with your competence. Connected with this is an exciting career path that leads you to ever new projects and solutions in the field of IT for Siemens Mobility. Here's where you make the difference As part of our Development Team, you have the technical responsibility for design, development and optimization of software core components for a web-based project management solution in the business area of Siemens Mobility. In your new role, you will design, develop and optimize core components of project management solution at Siemens Mobility. Understand business requirements and configure Opcenter Quality to meet requirements. Supports business processes as they relate to the Opcenter Quality. Works with other Business Analysts to develop best practices around the integration and deployment of Opcenter Quality Tools within existing architectures in a multi-site environment. Prepare test- cases and test for Opcenter Responsible for Opcenter support including analysis/requirements and project scope documents. What do I bring with me? Bachelors degree or equivalent in Electrical/Electronic/Computer Science or related discipline Working experience in the Siemens Opcenter and international environment (Minimum 3+) Experience in Opcenter Quality and Quality processes Experience with SAP Interfaces Knowledge of business workflow about QM Creation of requirements specification Design of enhancements through user exits or business add-ins, Experience in QM processes like Vendor qualification Incoming goods inspection Certificate processing Defect recording Inspection planning Integr. inspection processing Academic degree in Information Technology, Business Administration or comparable Qualification Fluent English language skills Knowledge of ORACLE Knowledge in Citrix terminal servers Highly self-motivated Customer-oriented Weve got quite a lot to offer. How about you? Competitive compensation An opportunity to craft the future of autonomous systems Extraordinary researchers and engineers as team members We are an equal opportunity employer and embrace diversity This role is based in Pune. Youll also get to visit other locations in India and beyond, so you’ll need to go where this journey takes you. In return, you’ll get the chance to work with teams impacting entire cities, countries – and the shape of things to come. If anyone interested above mentioned position. Kindly share your resume through my mail nareshkumar@gsr-inc.com Thanks & Regards, Naresh Kumar S HR IT Recruitment

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

Role & responsibilities 1. Primarily Responsible for Vendor Qualification and Vendor Approval accordingly and compilation of documents. 2. Handling of Issuance and Retrieval of batch number, batch manufacturing record, batch packing record, Register, Logbooks, SOPs, Formats, worksheets protocols, Analytical protocols of all departments. 3. Preparation, Review and compilation of the Annual Product Quality Review. 4. To prepare and review of quality and other departments SOPs. 5. Responsible for preparation and up-dation of quality assurance SOPs. 6. Responsible for preparation and up-dation of SOP’s Index of all the departments. 7. To handle and maintain specimen signature, job description etc. 8. To support the practice of documentation and data control. 9. To review the Analytical records, Batch manufacturing records and Batch packing records. 10. To identify and reporting of any non-conformance or any discrepancy related to manufacturing, packing and warehouse. 11. Preparation, planning, coordination and execution of Annual Training Program, assessment and handling of training records of all departments and to monitor/ Supervision and control over the workman in their designated premises at the site. 12. To ensure maintenance of environmental conditions (Relative Humidity, Temperature and Differential pressure) in respective areas. 13. Ensure to implementation of cGMP, GDP and Data Integrity in Plant Premises. 14. To handle the artworks approval, shade cards and other packing material. 15. To handle the preparation of material code in SAP & up-dation of BOM in SAP. Preferred candidate profile Qualification: B. Pharma/ M. Pharma Experience: 3 to 7 Years

Co-ordination for all the site (KOPL) with respect to dispatch activity from outsourcing site. Approving all procedures impacting the quality of intermediates or APIs e.g. SOPs, specification, standard test procedures, protocols etc. Coordination for Handling market complaints / Returns/Deviations / OOS. Handling change controls, deviations, market complaints, returned goods, product recall, OOS/ OOT, self inspection and corrective & preventive actions with respect to outsourcing site. Releasing or rejecting all APIs/ intermediates as per QMS systems for all the products which are manufactured at outsourcing site Organization of regulatory and customer Audits Organization of Meeting / Seminar / Presentation / trainings/ Management Review Meeting (MRM) etc. internally to achieve QMS Coordination for Technology Transfer Document (TTD) review and new product initiation. Reviewing and approving validation protocols and reports Approving intermediate and API contract manufacturers Ensuring that all Quality related complaints are responded as per SOP Review and Coordination for Batch Processing and packing record. Review of Quality Manual / VMP / SMF. Preparation and review of external audit responses then proposed CAPA monitoring. Maintaining Updated documents as per standard of ISO 9001:14001. Maintaining documents as per USFDA, CGMP, and other regulatory guidelines requirements. Ensure all the activities comply with EHS regulations and policies. Ensure Zero accident / Incident at work place Ensure all the activities / documentation as per the cGMP guideline Any other activities assigned by reporting manager.

Co-ordination for all the site (KOPL) with respect to dispatch activity from outsourcing site. Approving all procedures impacting the quality of intermediates or APIs e.g. SOPs, specification, standard test procedures, protocols etc. Coordination for Handling market complaints / Returns/Deviations / OOS. Handling change controls, deviations, market complaints, returned goods, product recall, OOS/ OOT, self inspection and corrective & preventive actions with respect to outsourcing site. Releasing or rejecting all APIs/ intermediates as per QMS systems for all the products which are manufactured at outsourcing site Organization of regulatory and customer Audits Organization of Meeting / Seminar / Presentation / trainings/ Management Review Meeting (MRM) etc. internally to achieve QMS Coordination for Technology Transfer Document (TTD) review and new product initiation. Reviewing and approving validation protocols and reports Approving intermediate and API contract manufacturers Ensuring that all Quality related complaints are responded as per SOP Review and Coordination for Batch Processing and packing record. Review of Quality Manual / VMP / SMF. Preparation and review of external audit responses then proposed CAPA monitoring. Maintaining Updated documents as per standard of ISO 9001:14001. Maintaining documents as per USFDA, CGMP, and other regulatory guidelines requirements. Ensure all the activities comply with EHS regulations and policies. Ensure Zero accident / Incident at work place Ensure all the activities / documentation as per the cGMP guideline Any other activities assigned by reporting manager.

Job Responsibilities: 1. Monitoring and Assessment of QMS related activities for all API sites (Nerul, Chiplun and Ambernath) and Govandi (CPRL, PAN, BRL etc.). 2. Change Controls: Review and closure of change controls, approval and closure of actions childs, CQA Assessment etc., 3. Review of Customer Complaints, Risk Assessments, Deviations, CAPAs, Investigations, Recalls etc., 4. Handling of Customer Quality agreement and co-ordination with cross functional team till execution of the agreement. 5. Tracking of CQA SOPs as per the review date, by maintaining the SOP Periodic review tracker and master SOP list. 6. Preparation/Revision of CQA SOPs and making master, effective after completion of training. 7. Review of Master formula and technology transfer documents for API sites. 8. Master product label information update in Traces application as per the site requirement. 9. To provide training of SOPs, cGMP, or other modules as per the requirement. 10. Review of SOPs related to various departments of corporate functions (e.g. CPRL, PAN Lab, HR etc). 11. Scheduling and participation in self-audits (Sites and corporate functions). 12. Regulatory and customer audit support to sites. 13. Review of Specifications for raw material, intermediate, finished API, working standard, GTPs of API Sites in DocuSign. Master and making effective through DocuSign and distribution of controlled copies to site and CFTs. 14. Handling Customer Questionnaires, Regulatory Agencies Questionnaires and Customer queries as per the requirement. 15. Participation in Quality related meetings. 16. Shall perform any other related work/projects assigned by CQA HOD/Section head.

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