53 Qualification Jobs - Page 2

The Vice President of Business Development position at our rapidly growing SaaS organization requires a dynamic and results-driven individual to lead enterprise sales initiatives. In this high-impact role, you will engage with global enterprise clients in various verticals such as logistics, ERP, HRMS, fintech, real estate, media tech, and IT services. Your responsibilities will include owning and driving the end-to-end enterprise sales cycle, building relationships with C-level stakeholders, developing account-based strategies, leveraging CRM tools, collaborating with cross-functional teams, leading a business development team, and staying updated on industry trends. To excel in this role, you should have 12-22 years of experience in enterprise business development, preferably in a SaaS/tech-first organization. You must have a proven track record of selling to large global enterprises, exposure to domains like transportation, ERP, warehousing, HRMS, or enterprise software, and success in international markets, particularly in the US. Strong consultative selling skills, willingness to travel, excellent communication and negotiation abilities, and prior experience in team leadership are essential qualifications. We are looking for someone with a strategic, high-energy, and aggressive business development approach, who can thrive in a fast-paced, agile, and performance-driven environment. Your commercial acumen and ability to translate business problems into tech-led solutions will be key to driving success in this role. If you have a strong background in tech sales, particularly in SaaS, and are excited about leading enterprise sales initiatives, we would love to hear from you. Please note that this is a work from office role based in Mumbai or candidates must be willing to relocate to Mumbai.,

You will be responsible for performing commissioning and qualification of Pharmaceutical equipment, specifically systems for Oral Solid Dosage, Injectables, and Fill/Finish. This includes a variety of equipments such as RMG, CoMil, Tablet press, Coating Machine, blister packing machine, Vial Filling Line, PFS Line, Isolators (Negative & Positive), RABs (Open and Closed), GL Reactors, Dryer, Nutsche Filters, Centrifuges, Lyophilizers, etc. Your responsibilities will include developing CQMP, VMP, FRA, cGMP review sheet, interdependencies, System boundary, URS, SCA/SLIA, CLIA, DQR, SRA/QRA, SAT protocol, commissioning protocol, IQ protocol, OQ protocol, PQ protocol, process validation, and cleaning validation protocol. You will execute Commissioning, qualification, and validation activities for Pharma Process Equipments for API, Fill/Finish, and OSD. Additionally, you will review, analyze, and interpret system performance data, handle deviations/discrepancies, conduct investigations, CAPA, and ensure promotion of cGMP and regulatory compliance in assigned projects. Furthermore, you will exercise good judgment in selecting methods and techniques for obtaining solutions, maintain GDP, ALCOA practices, and have hands-on experience with Pharma Process Equipments. Drafting equipment operation SOPs will also be a part of your role. Qualifications & Other Requirements: - BS/MS in Engineering (Chemical, Pharma). - 4-10 years of experience in validation, quality systems, operations, engineering, or a combination thereof. - Experience in multiple GMP validation disciplines with advanced technical knowledge. - Knowledge of Validation Lifecycle approach, international regulatory requirements, and standards. - Experience with Documentum or Maximo is a plus. - Strong verbal and written communication skills, excellent organizational and time utilization skills. - Ability to work independently and within project teams. - Industry experience related to cGMP drug manufacturing, validation, and chemical process design. - Strong computer knowledge including Microsoft Office products.,

Imagine what you could do here. At Apple, new ideas have a way of becoming extraordinary products, services, and customer experiences very quickly. Bring passion and dedication to your job and there's no telling what you could accomplish. The people here at Apple don't just create products - they create the kind of wonder that's revolutionized entire industries. It's the diversity of those people and their ideas that inspire the innovation that runs through everything we do, from amazing technology to industry-leading environmental efforts. Join Apple and help us leave the world better than we found it. In this highly visible role, you will have the opportunity to make a significant impact on Apple products and leave a footprint for years to come. We have an opportunity for an accomplished quality engineer to lead development and ramp for a next-generation Apple product. Our quality engineering team enables the mass creation of impossible products as a partner in the development of batteries that power Apple's renowned designs. Partner with multi-functional teams to evaluate design and processes at the concept phase. Develop measurement technologies, control strategies, information systems, and manufacturing methods that achieve ambitious specifications at massive production scale. Develop and implement groundbreaking quality inspection tools to evaluate cosmetic and dimensional part characteristics. Compile and evaluate data to figure out appropriate limits and variables for process and part specifications. Lead activities to balance unparalleled quality with scalable yields. Collaborate with internal and external groups to ensure the proper definition of quality expectations and that appropriate assurance techniques are used for the product. Coordinate all Quality Engineering functions for a program, serving as a project manager to lead efforts at supplier locations. Establish audit procedures appropriate to the program and supplier to ensure alignment with Apple quality standards. Evaluate and communicate yields of new and existing processes. Drive corrective actions multi-functionally with internal and external team members. Minimum Qualifications: - Experience with battery development, design, and/or qualification in mass production settings. - Knowledgeable about current state-of-the-art production processes of lithium-ion battery electrodes and coatings. - Hands-on experience with battery performance characterization techniques and reliability testing strongly desired. - Experience developing processes quality plans, supplier quality audits, and driving corrective actions/failure analysis efforts. - Familiarity with GD&T practices, Metrology, DFMEA, and tolerance analysis. - Project management experience and a deep understanding of problem-solving tools including design of experiments, root cause analysis, and statistical tools. - Strong communication skills and passion to learn and adapt to a dynamic environment. Preferred Qualifications: - Experience building MES solutions based on ML - all the way from inception to production. - Experience in Failure analysis tools like SEM, TEM, FIB is an added bonus. - Experience developing process quality plans, supplier quality audits, and driving corrective actions and failure analysis efforts. - Working knowledge of mechanical quality and reliability concepts, supplier management, and general manufacturing operations. - Experience with the development and evaluation measurement systems. - Bachelor's degree in Chemical Engineering, Material Engineering, or Mechanical Engineering. ME/MS or PhD preferred. Submit CV.,

Validation Master Plan (VMP, PVMP, CVMP, QMP) Qualification and Validation Documents and execution BMR, BPR, log book, Protocol, Report and SOP Required Candidate profile Preparation and review of PPQ and cleaning validation protocol monitoring of PPQ and cleaning validation activities To prepare and review (SOP's) and procedures related to validation

Job Description: As a Business Development Manager at Exela, your primary responsibility will be to build up a database for campaigns and generate qualified leads and opportunities. You will play a crucial role in coaching the team members and taking the initial discussions to the qualification level. The focus will be on database buildup, lead/opportunity generation, and developing first-level interest. It is essential to possess a strong understanding of the domain to excel in this role. Exela is a business process automation leader with a global footprint and proprietary technology that enhances quality, productivity, and end-user experience. With decades of expertise in operating mission-critical processes, Exela serves a diverse customer base across various industries worldwide. As a Business Development Manager, you will contribute to Exela's growth by driving lead generation and new business development initiatives. Join Exela's team of over 17,500 employees operating in 23 countries and be a part of our end-to-end digital journey as a strategic partner. Your role will be instrumental in expanding Exela's reach and impact in the market, working with a growing roster of customers in more than 50 countries. If you are looking for a challenging yet rewarding opportunity in business development and lead generation, this role at Exela might be the perfect fit for you.,

The opportunity available is for the position of Secretary at EY in Kolkata within the CHS-Assurance-CBS - AWS - ASU Exec Assistants team. The CHS sector encompasses Consumer Products and Healthcare sectors. Consumer products within this sector involve Retail and Agri business, catering to the needs of consumers globally by offering agricultural crops, food, clothes, durables, and retail experiences. The focus is on assisting clients in achieving new avenues of profitable growth by redefining value propositions for consumers both in the present and future. The Health Sciences & Wellness segment aims to leverage a global network of professionals to develop data-centric strategies for customer engagement and enhanced outcomes. Participants in this sector are encouraged to revamp their business strategies to align with the digital and data-driven landscape, emphasizing capital strategy, partnerships, and patient-centric operational models. Assurance, a core function, aims to instill confidence and trust in the business environment by safeguarding the public interest, enhancing transparency, boosting investor confidence, and nurturing talent for future business leaders. The key responsibilities include ensuring audit compliance, offering a clear perspective to audit committees, and delivering crucial information to stakeholders. Service offerings encompass External Audit, Financial Accounting Advisory Services (FAAS), IFRS & US GAAP conversion, IPO support, Corporate Treasury services, and IFRS 9 accounting & implementation support. The ideal candidate for the Secretary role should possess the necessary qualifications and experience in this field. EY values individuals who can collaborate effectively across various client departments, adhere to commercial and legal standards, and approach problem-solving with a practical mindset. Candidates are expected to be agile, curious, mindful, and capable of maintaining positive energy while showcasing adaptability and creativity in their work approach. EY, with a vast client base and a strong workforce globally including 33,000 professionals in India, is recognized as a premier employer in the industry. The organization offers a dynamic work environment where employees collaborate with leading entrepreneurs, disruptors, and visionaries. EY prioritizes investments in skills development and learning opportunities for its workforce, providing a personalized Career Journey and access to career frameworks for role clarity and growth prospects. EY is committed to fostering an inclusive work culture that enables employees to deliver exceptional client service while focusing on personal career advancement and well-being. Interested candidates who meet the specified criteria are encouraged to apply promptly and contribute to building a better working world with EY. Apply now to be part of a globally renowned organization dedicated to driving positive change and growth.,

Role & responsibilities Incharge for QMS activities, Preferred candidate profile Should have good knoledge about QMS, Validation, calibration , qualification, re-qualification, change control. CAPA, OOS, OOT & Investigation. Mainly for all Process equipments and Utility ( HVAC System, Purified System, Refrigerator System, Air Compressor System & Boiler ) Exposure with Regulatory Aduits.

You will be joining Yanolja Cloud Solution Pvt. Ltd. (YCS) - a global hospitality technology provider with more than 450 team members and 17 years of experience. YCS serves over 33,000 customers across 170 countries, offering solutions in 50 languages and providing 24/7 support. With local teams in 15 countries, including India, Thailand, and the USA, YCS is dedicated to catering to small and medium-sized accommodation businesses worldwide. As a Driven Sales Professional, your role will involve exceeding sales targets by generating and qualifying leads and effectively closing deals. Building relationships with decision-makers and understanding their needs will be crucial. Your strong communication and negotiation skills will enable you to engage with customers, address objections, and secure successful deals. Your customer-focused approach will emphasize exceptional service and the development of long-term relationships based on tailored solutions. Your responsibilities will include exploring the target market, identifying leads, and approaching them through calls. Utilizing sales scripts, you will drive sales and handle customer rejections effectively. Understanding hotel operations and the technology they use will be essential, as well as addressing customer queries and issues promptly. Building and maintaining relationships with existing customers, understanding their technological priorities, and converting hot leads into closures will be key tasks. You will be expected to meet daily and monthly targets for call volume and sales, ensuring you meet quarterly and annual sales targets. Informing clients about new product developments, developing quotes and proposals, negotiating deals, and providing round-the-clock customer support will be part of your routine. Identifying campaign opportunities, forming alliances with partners and consultants, and winning sales in enterprise accounts will also be critical to your role. Key competencies required for this position include proficiency in lead generation, exceptional communication and presentation skills, a solid understanding of IT products in the hotel operations domain, sales acumen, relationship-building skills, negotiation abilities, commitment to customer service, effective time management, resilience, target orientation, and a proven track record in telesales. To qualify for this role, you should have at least 1 year of telesales experience, fluency in English, Hindi, and Gujarati, willingness to work in the US shift, excellent communication skills, the ability to learn IT products, patience, the capability to manage clients calmly, follow scripts, strong negotiation skills, exceptional customer service skills, and a proven sales track record in telesales.,

Dear All, We are conducting Walk-in Interview at Indore for our OSD manufacturing Facility based out of our Ahmedabad (SEZ-II), please find the below details. Date : 13th May 2025 (Sunday) Interview Location: Indore Timings: 9:00 am 5:00 pm Interview Venue: Enrise By Sayaji Rau, Survey No. 27/1 27/2, Village Pigdambar Rau Tehsil Mhow Ab Road Job Location: Ahmedabad Education Qualification: ITI/Diploma/BSC/ B.E/B.Tech/B.Pharma Departments are as follows : Production- OSD : Plant Operator/ Technical Assistant : ITI / Diploma having 3 - 8 years of experience in operating machines like Granulation (ACG, Glatt, Tapasya, GEA), Fitzpatrick Roll Compactor, Compression machines (Fette), Wurster Coater (ACG, Glatt, Anish), imprinting, Visual Inspection. Perform line clearance, operation and cleaning of equipment / instrument / auxiliary items Executive/ Sr Executive: B. Pharma with 3 - 8 years of experience in Tablet/ Capsule department with experience in Granulation, Compression, Coating, Inspection . Responsible to plan for the manufacturing of batches in coordination with PPMC. To monitor line clearance, cleaning of equipment, instrument, auxiliary items. To carry out qualification activities. To initiate QMS activities (Change control, deviation, CAPA, investigation) and E-BMR. To handle manpower and allocate daily activities.. Engineering: Technician : Diploma / ITI with 3- 8 years of experience in plant maintenance & Process Equipment (Electrical/ Instrumentation) and Instrumentation . Candidates should have experience in Plant maintenance, preventive maintenance and breakdown maintenance of OSD plant equipment. Troubleshooting of mechanical and electrical equipment . Instrument and calibration of OSD plant equipment. They should have knowledge and experience in instruments sensors, PLC, HML, SCADA, and experience in calibration activities. Sr. Executive/ Assistant Manager: B.E/ B.Tech with 5-10 Years Process Equipment( Electrical / Instrumentation), Instrumentation, Water System and Utility . Candidates should have experience in Plant maintenance, preventive maintenance and breakdown maintenance of OSD plant equipment. Troubleshooting of mechanical and electrical equipment . Instrument and calibration of OSD plant equipment and Utility. They should have knowledge and experience in instruments sensors, PLC, HML, SCADA, and experience in calibration . QMS documentation exposure is required. Quality Assurance (Qualification) Assistant Manager / Deputy Manager / Associate Manager: B.Pharm with 10-20 years QA & MFG Qualification. Candidates should have experience in Qualification, Validation. They would have to prepare, execute and review of equipment/ instrument/ system /utility /area qualification program. Review of data backup activity, data restoration and its compliance. QMS documentation exposure is required. completion of CAPAs and to perform change control/CAPA effectiveness. Associate Manager: CSV B.Pharm with 15-20 years with experience in Issuance and retrieval of documents. Candidate should have experience in Review of various Qualification and CSV Documents. Review of system audit trail, system security user privileges and ensure the compliance. Review of data backup activity, data restoration and its compliance. To ensure timely completion of CAPAs and to perform change control/CAPA effectiveness. Quality Control: Assistant Manager & Deputy Manager: Planning & review of reports in Raw Material & Packing material section Executive / Sr. Executive : Analyst - Expertise in analysis of In-process, process validation, FP and method transfer of solid dosage forms (Tablets / capsules) and Raw material with hands on experience in HPLC, UV, Dissolution, GC, IR, Polarimeter, Malvern 3000 etc For all the positions, candidate should have exposure in pharmaceutical company and exposure to regulatory requirements of documentation and cGMP will be added advantage. Interested candidates Please Walk-in for an interview along-with their Aadhar Card, Passport size Photograph, updated CVs, Salary Structure, Salary Slip and relevant documents(original as well as Photocopies) as per the schedule.

We are looking for a technically proficient and customer-oriented Field Application Engineer (Automotive/Industrial) to join our teams in Pune & Delhi. As a Field Application Engineer, you will be responsible for handling market segments such as Automotive/Industrial (Metering & IOT) and product segments including Passive Electronic components. The role requires 3-5 years of experience in the Semiconductor Industry and a Bachelor's degree in Electronics/Electronics & Communications/Instrumentation. Your responsibilities will include contributing to business growth through prospecting, qualification, and product design-in, as well as providing technical support in identifying new applications and making product recommendations. You will also be responsible for managing regional demand creation accounts, participating in training & sales meets with OEMs, and supporting clients for DWIN activities. Additionally, you will interact with Design (R&D) and Product Engineering teams to troubleshoot technical and operational issues. To excel in this role, you must possess strong networking and presentation skills, excellent English communication skills, and be consumer-oriented with problem-solving and analytical abilities. You should also be result-oriented, a team player, and a go-getter. We offer a competitive compensation package, incentives, growth opportunities, technical skills development, and various benefits including health insurance, accident insurance, term plan, gratuity, EPFO, maternity and paternity leaves. If you meet the qualifications and skills outlined above, we encourage you to apply by sending your updated CV to careers01@unified.co.in. You can also refer a friend who would be a good fit for this role by sharing their CV with us. Join us in our journey of abundant growth and collaborative teamwork by exploring this exciting career opportunity with Unified GlobalTech (I) Pvt Ltd. For more information about our company, please visit our official website at https://unified.co.in/. United We Grow!,

Ally Wiredsoft is a global management consulting, technology services, and outsourcing company dedicated to delivering exceptional value to medium and large global customers. Our approach revolves around leveraging technology and a flexible delivery model to enhance performance and drive business value across the customer's enterprise. We pride ourselves on offering a comprehensive service approach that goes beyond mere delivery by integrating enterprise solutions and services, proprietary best practices, strategic application and maintenance outsourcing, as well as consulting and integration services. Our team at Ally Wiredsoft is committed to providing the best value to our clients by combining a highly experienced workforce, well-defined processes, state-of-the-art technologies, and client management solutions. This commitment to excellence keeps us ahead of market competition. By utilizing established techniques, tools, processes, and methods, our IT consultants deliver industry-leading solutions and services, while significantly reducing project cycle times. As a trusted partner to clients globally, we focus on understanding growth plans and identifying opportunities where clients can leverage best practices. Key Offerings: - Software solutions - Application Development Management - Business Intelligence - Data Science Position Overview: Ally Wiredsoft is seeking a Software Advanced Quality Engineer (SW AQE) to play a crucial role in verifying internal and external customer needs, as well as ensuring the implementation and tracking of those requirements by the engineering team. The SW AQE will be responsible for challenging and supporting the software organization in establishing and maintaining ASPICE. Additionally, the SW AQE will support internal and external software assessments and external audits related to ASPICE and IATF. Key Responsibilities: - Define quality needs on projects - Quality planning throughout the product lifecycle - Ensure quality of requirements and their management - Maintain quality goals in software development - Ensure alignment of quality targets with project planning - Communicate/report to customers and other quality stakeholders - Propose and implement process improvements - Participate in ASPICE development within the organization - Responsible for software quality deliverables Expected Competencies: - Proven ability to execute engineering deliverables - Strong organizational skills and autonomy - Expertise in automotive SPICE and IATF environments - Knowledge in requirement engineering, static analysis, unit test, integration test, and qualification - Problem-solving skills (e.g., 8D methodology) - Excellent motivational skills and ability to achieve goals in a fast-paced environment - Collaboration with internal customers in different time zones - Attention to detail and on-time delivery - Clear, strategic thinking to identify and solve complex problems Preferred Qualifications: - Bachelor's or Master's Degree in Computer Science, Electrical, or equivalent - Experience in automotive software development - Project management experience - Functional safety environment experience - Team spirit and collaborative mindset Why Join Us: - Opportunity to work with a dynamic and collaborative team - Gain valuable experience in a challenging environment - Competitive salary and benefits package - Professional growth and training opportunities - Contribute to the success of our organization by optimizing your skills Education: - Bachelor's degree preferred Experience: - .NET: 5 years required - Total work experience: 5 years required - Java: 5 years required Job Type: Full-time Schedule: - Day shift, Monday to Friday Work Location: In person,

The ideal candidate for this role will be responsible for the following key functions: Prospecting and Lead Generation: You will be tasked with identifying and targeting potential clients by utilizing various methods such as cold calling, email campaigns, and social media to build a strong lead pipeline. Engagement with Senior Stakeholders: Your role will involve conducting effective outreach to senior stakeholders within large enterprises, with a focus on nurturing relationships and showcasing CashFlo's solution. Product Knowledge and Presentation: You will need to acquire a comprehensive understanding of CashFlo's SaaS-based AP automation platform and effectively present its value proposition to potential clients. Qualification and Handover: It will be your responsibility to qualify leads based on specific criteria and collaborate closely with the sales team to ensure a seamless transition of qualified leads. Market Intelligence: Staying informed about industry trends, competitor activities, and market dynamics will be essential in providing valuable insights for continuous improvement. Reporting and Metrics: You will be expected to maintain accurate CRM records and regularly report on key performance indicators (KPIs) such as conversion rates and the effectiveness of outreach efforts. To excel in this role, you should possess the following qualities: Communication Skills: Demonstrating exceptional verbal and written communication skills, with the ability to adapt communication styles to effectively engage with senior stakeholders. Sales Acumen: Showcasing a proven track record in sales or business development, along with familiarity in various sales methodologies and techniques. Product Knowledge: Previous experience in a SaaS product company is desirable, coupled with the ability to clearly articulate technical concepts. Strategic Thinking: Exhibiting strategic thinking in identifying opportunities for business growth and demonstrating proactive problem-solving skills. Team Collaboration: Collaborating effectively with cross-functional teams, particularly with the sales team, to ensure alignment and success in achieving objectives.,

Role: Consultant - Inside Sales Reports to: Sr Director New Business Development Profession: Inside Sales Office Location: Bangalore Job Description The Executive of Inside Sales will play a fundamental role in achieving our ambitious customer acquisition and revenue growth objectives. You must be comfortable making dozens of outreaches per day, working with several stakeholders, qualifying prospects, building strong pipeline. Responsibilities Responsible for bringing New Logos through Inside Sales. This includes strong market research, qualifying prospects and building strong pipelines. This will be accomplished by sourcing new sales opportunities through inbound lead follow-up and outbound emails. Understanding how customer needs and requirements align to internal capabilities. Routing qualified opportunities to the appropriate executive team member for further development and closure Research accounts within Pharma & Biotech, Medical Device and identify key players and generate interest. Maintain and expand database of prospects, finding new contacts and targets for New Logos Qualifications Must have experience of 4+ years in inside sales, business development. MBA/PGDM candidates with background in Inside Sales Experience in Lead generation, Qualification, Prospecting, Negotiation, Market Research, and end-to-end sales. Excellent communication, negotiation & interpersonal skills Extensive knowledge about Market Research, Database Development, handling tools like CRM (salesforce/HubSpot) is mandatory. Able to forecast quarterly/monthly pipeline to build GTM strategy for new Logo acquisition. Experience in Retail/CPG, Pharma/Biotech vertical and SaaS selling is an added advantage. Must be goal driven and self-motivated to achieve annual targets. Must be comfortable working with prospects located in US & Europe,

As a Sales Executive at our company, you will be responsible for various key tasks. You will focus on Lead Generation and Qualification by proactively researching and identifying potential B2B clients in the corporate and HoReCa sectors. Utilizing a variety of lead generation techniques such as industry research, networking events, and cold calling, you will qualify leads based on their needs, budget, and decision-making authority. Your role will also involve Relationship Building and Client Management, where you will develop and nurture relationships with key decision-makers at potential client companies. Understanding client pain points and effectively presenting Boon's solutions will be crucial. Managing client relationships throughout the sales cycle, building trust, and fostering long-term partnerships will also be a part of your responsibilities. In terms of Sales Process and Execution, you will be expected to prepare compelling sales presentations tailored to client needs and objectives. Negotiating and closing deals while ensuring compliance with company pricing and sales policies will also fall under your purview. Managing and tracking sales opportunities through the CRM system will be essential for effective sales management. Your responsibilities will also include Market Research and Competitive Analysis. Staying updated on industry trends and competitor activities, conducting market research to identify new business opportunities, and preparing reports on sales activities, market trends, and competitor analysis will be crucial for developing tailored sales strategies. To qualify for this role, we are looking for candidates with a Bachelor's degree in Business Administration, Marketing, or a related field (preferred). Ideally, you should have 1-2 years of experience in B2B sales, with a proven track record of exceeding sales targets and achieving revenue goals. Excellent communication, presentation, and interpersonal skills are essential, along with strong analytical and problem-solving abilities. The ideal candidate should be able to work independently, manage multiple priorities effectively, and be self-motivated with a strong desire to succeed in a fast-paced environment. Experience in the HoReCa industry would be considered a plus. In return, we offer a competitive salary and benefits package, along with the opportunity to work for a growing and innovative company. You will be part of a dynamic work environment that focuses on professional development, providing you with the chance to make a real impact on Boon's success.,

Opening for an Pharma Compay. Location : Bhiwadi. Job Description: Hands-on experience in QA documentation Qualification and validation activities QMS (Quality Management System) activities Interested candidates shared resume on snehal@topgear@gmail.com

Role & responsibilities Develop, execute, and document qualification protocols (DQ/IQ/OQ/PQ) for equipment, utilities, and facilities. Collaborate with Engineering, Production, QA, Or other Cross functional teams to coordinate qualification activities. Maintain qualification documentation, including risk/impact assessments and change-control records. Ensure compliance with USFDA, MHRA, WHOGMP, and ICH Q9/Q10 standards. Support internal and external audits and inspections focused on qualification. Diagnose deviations in qualification processes and initiate CAPAs. Manage and update the Qualification Master Plan and requalification schedules. Specialize in injectable product qualification (media fill, aseptic simulation, smoke studies). Oversee qualification of systems such as water, steam, HVAC, filling/sealing machines, autoclaves, isolators, washing tunnels/DHS units, and more Preferred candidate profile Deep knowledge of qualification and validation best practices (equipment, utilities, facilities) and Hands-on experience with media fill/aseptic simulation, smoke studies, and utilities (water, steam, HVAC). Proficient in URS/DQ/IQ/OQ/PQ processes for various equipment (vial/ampoule washers, filling/sealing units, autoclaves, isolators). Strong understanding of equipment qualification, utility validation, and cleanroom classification. Familiarity with cGMP, data integrity (ALCOA+), and GxP documentation standards. Competent in creating/reviewing technical documentation and qualification protocols in line with regulatory requirements. Excellent analytical and problem-solving skills, with a methodical attention to detail. Proven ability to collaborate cross-functionally and interface confidently during audits and inspections.

Job Title: QA Assistant / Executive - API Industry Location: Kakinada, AP Company: Lyfius Pharma About Lyfius Pharma is 100% subsidiary of Aurobindo Pharma. Its largest API Unit of Aurobindo. Lyfius spread across 236 acres in Kakinada SEZ and it is second largest API manufacturing facility in ASIA. Qualification: M Sc / B Sc/ B Pharm Experience: 2 to 10 Years Job responsibilities: Quality Management System QMS Handling & Responsible for: Change Control, Deviation, Out of Specification, Market Complaint, Corrective and Preventive Action (CAPA) Annual Product Quality Review. Audit Compliance Report Preparation. Document Controller All document Issue, Review & Retrieval COA preparation BMR & BPR Preparation & Review Specification, Method of Analysis & Protocol & Report preparation for Finished product, Intermediate product, In-process, Raw material, Packing material. Standard Operating Procedure (SOP) Preparation Site Master Plan & Validation Master Plan Preparation Technical Data Package (Tech Pack), Formula Master Preparation. All Declaration Preparation for regulatory submission, Customer Free Sample, Vendor Sample and Customer Query Related work. Policies & system procedures preparation. External Manufacturing & Toller documentation Control & Follow-up. Training Calendar preparation and control. Qualification / Calibration / Validation Responsible for all Calibration activity Internal & External and maintained the record. Responsible for Equipment Qualification & Documentation control Vendor Qualification and regular follow up for updated documentation by the supplier, Process Validation Protocol & Report Preparation Cleaning Validation Protocol & Report Preparation Analytical Method Validation Protocol & Report Preparation IPQA Issue and control of SOPs, BMRs, BPRs, BCRs and also finished product label/product container seals /sealing of the containers as the part of IPQA activities. Review BMRs, BCRs and analysis records before release of API. Perform sampling of APIs, maintain its records and ensure the cleaning of sampling tools. Provide line clearance at the time of product changes over. Perform the documentation control activity at site. Monitor/Maintain/Review of Records and Handling of controlled/Retained samples of Intermediates/Finished API.

Responsible for review and execution of SOP, Master BMR and BPR,Qualification document and Validation Document.IPQA activities on Injectable,CAPA,QA SOP's,ensure the cGMP compliance,To review the audit trail report.Calibration Preventive maintenance

Responsible for review and execution of SOP, Master BMR and BPR,Qualification document and Validation Document.IPQA activities on Injectable,CAPA,QA SOP's,ensure the cGMP compliance,To review the audit trail report.Calibration Preventive maintenance

Job Role : Manager Validation Location : Mohali Responsibilities : Build a cohesive Team to support Validation activity in A- 41 Mohali Location Collaborate for creating a robust CAPA program Equipment and facility Validation of A- 41 Mohali Location, along with site Specific teams, which includes preparation, review and execution of protocols, and Master Validation documents. Preparation, Review and execute protocols & reports in facility involving utilities, engineering, manufacturing operation & cleaning which shall include but not limited to HVAC, water, compressed air, process/packing equipment w.r.t. qualification & validation To ensure that all qualification and validation protocols include critical steps / components which are to be checked and validated To prepare, review & ensure compliance & written procedure w.r.t. validation function To co-ordinate, review and manage the training needs and records as a department training coordinator (DTC). To prepare validation planner for all utilities and equipments To ensure the implementation of current good manufacturing practices To look after the maintenance & improvement of product quality as per specification To provide the training to personnel involved in validation activities as & when required Participate in Quality Improvement projects To ensure that all systems and equipments are validated as per the procedure/ requirements and calendar Responsible for Quality Management System compliance i.e., Handling of Deviation, Investigation, CAPA and CCR Responsible to perform the internal and external audit as per the site specific procedure. Any other responsibility that may be assigned from time to time Education Qualification : B.Pharm / M.Pharm Experience : 12 to 15 Yrs (in Validation / Qualification)

HIRING FOR FORMULATION UNIT - INJECTABLE/ OSD JOB DESCRIPTION AND EXPERIENCE: WORK LOCATION: Hetero Labs Limited, UNIT V & VI, Polleypally, Jadcherla, Mahabubnagar PRODUCTION(OSD) Experience: (02-07Years) Compression, Granulation, Coating, Capsule filling, Inspection PRODUCTION (INJECTABLE) Experience: (02-07Years) Autoclave, Compounding, filling, QMS, Vial Washing, Lyophilizer, Visual Inspection PACKING (INJECTABLE/OSD) Experience: (01-05Years) Blister Packing, Bottle Packing. QC & QC- Micro Experience: (02-07Years) HPLC, GC, RM,PM, Stability, IP/FP,MLT, Environmental monitoring, QA-INJECTABLE Experience: (02-07Years) IPQA, Validation, Qualification, CSV, AQA (QC & Microbiology) WAREHOUSE Experience: (01-07Years) Raw Material, Packing Material, Finished Goods QUALIFICATION : I.T.I, Diploma, B.Com, B.Sc, B.Tech, B. Pharm, M.Sc with relevant experience DESIGNATIONS: Operator, Sr.Operator, Jr.Officer, Officer, Jr.Executive, Executive & Sr. Executive INTERVIEW VENUE: Hotel: UJWALA GRAND Gandimaisamma, gandimaisamma- Medak Road, Hyderabad, Telanagana- 500043 DATE &TIME: 28th & 29th June'2025 (Saturday & Sunday); From 09.00 A.M. to 03.00 P.M NEED TO CARRY: Resume, 3 Month Pay slips, Increment letter, Previous company relieving letters, Education Documents and ID Proofs Help Us Spread the Word (Refer): Circulate it in your Social Networking sites and groups for better reach and Refer your friends and colleagues, it could be a great opportunity for someone in need! CONTACT INFO: E-mail: Harishwar.m@hetero.com & Cont: 8121036004 for further info

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. 4. Handling of Incidents, Deviation, CCP, OOS, OOT and Material Rejections 5. Issuing BARCODES for new Registered products in coordination with regulatory department. 6. Working Hands on MARKET COMPLAINTS and CAPA. 7. Preparation of Master Formula Record (MFR) and Preparation Of (SOPs). 8. Preparation of EQUIPMENT QUALIFICATION documents i.e. IQ, OQ, PQ protocol and Reports during Installation of New Instruments/ Equipments. 9. Identification of Hazard and Calculation of Risk associated with product or daily activity. 10 Participation and Handling of SELF INSPECTION Reports (INTERNAL AUDIT). 11. Preparation of Audit & Maintenance of Post Audit Documents (compliance reports). Desired Candidate Profile Bachelor's degree in Science (B.Sc) or Pharmacy (B.Pharma). Male candidate will be preferred.

Role & responsibilities protocol Preparation, review and execution for plant qualification preparation of process validation protocol, preparation and compilation of validation report co-ordinate for 3rd party calibration risk assessment preparation annual product review QMS, Change control, DEviation Preferred candidate profile B.Pharma/M.Sc with minimum 6-8 yrs experience in QA. candidate must have exposure of working in regulatory pharma plant.

We are hiring for a Green Field Projects at Amneal , Ahmedabad. Following is the JD : Key Responsibilities : Lead QA operations related to Qualification & Validation, including Cleaning Validation, Process Performance Qualification (PPQ), and Computer System Validation (CSV). Develop and implement Validation Master Plans (VMP), Contamination Control Strategies, and Quality Risk Management (QRM) frameworks. Ensure qualification and validation of manufacturing equipment, utilities, and computerized systems to meet regulatory requirements. Drive regulatory inspection readiness, acting as SME for audits including USFDA, EMA, ANVISA, and WHO. Implement and optimize QMS using a risk-based approach, ensuring continuous monitoring and integration of compliance standards. Oversee execution of large-scale validation projects, such as Green Field Injectable facilities, and ensure regulatory approval readiness. Collaborate cross-functionally with Quality, Engineering, Production, and Regulatory Affairs teams for the successful and timely delivery of validation-related initiatives. Promote lean validation practices and continuous improvement strategies to enhance operational efficiency and regulatory compliance. Mentor, develop, and manage a high-performing QA validation team in a cross-cultural, fast-paced environment. Key Requirements : Education : Bachelors or Masters degree in Pharmacy, Chemistry, or related life sciences field. Experience : Minimum 15 years of experience in QA with strong specialization in Qualification & Validation within pharmaceutical manufacturing. Proven experience in injectable/sterile manufacturing environments is highly desirable. Hands-on experience in handling international regulatory audits and validations across FDA, EMA, and ANVISA-regulated markets. Technical Skills : Expertise in Cleaning Validation, PPQ, CSV, QRM, and VMP development. Strong command of GxP and global regulatory guidelines. Proficient in developing and managing QMS with focus on compliance and risk management. Leadership Skills : Demonstrated ability to lead cross-functional teams, influence stakeholders, and manage complex projects under tight timelines. Strong communication, decision-making, and coaching capabilities. Preferred Attributes : Green Field project experience, especially in injectables. Recognized as an SME in QA Validation. Familiarity with modern digital QA tools or systems is an added advantage. Interested candidate can share CV at bhuvneshwari.rathore@amneal.com

External Job Description Job title: Qualification & Validation Expert, Report Issuance Location: Hyderabad About the job Sanofi is a global life sciences company committed to improving access to healthcare and supporting the people we serve throughout the continuum of care. From prevention to treatment, Sanofi transforms scientific innovation into healthcare solutions, in human vaccines, rare diseases, multiple sclerosis, oncology, immunology, infectious diseases, diabetes and cardiovascular solutions. As a company with a global vision of drug development and a highly regarded corporate culture, Sanofi is recognized as one of the best pharmaceutical companies in the world and is pioneering the application of Artificial Intelligence (AI) with strong commitment to develop advanced data standards to increase reusability & interoperability and thus accelerate impact on global health. The Global M&S Services acts as a cornerstone to this effort. Our team is responsible for delivering and supporting Global M&S teams by acting as a crucial link between our R&D and Manufacturing facilities, playing a vital role in securing the present portfolio and delivering future launches of high-quality and innovative drugs and vaccines. Main responsibilities: Apply and align documentation standards with global quality team. Ensure that qualification reports and activities adhere to all applicable quality regulations and pharmaceutical practices. Validate that qualification activities meet health-related requirements, including safety and environmental standards. Review qualification protocols, reports, and documentation for accuracy, completeness, and compliance. Collaborate with cross-functional teams, including Quality Assurance, and Engineering, to ensure alignment and consistency in qualification practices. Provide training and support to team members on compliance-related topics and best practices. About you: Experience: >5 years professional experience in qualification Soft skills: Proficient in problem-solving, attention to detail, and good organizational skills. Ability to work collaboratively with cross-functional teams in a flexible and proactive manner. Strong analytical skills. Agile thinker and learner, adaptable to complex & dynamic environments Technical skills: Quality systems (e.g., Veeva, Kneat), Word, Excel, Power Point Education: Bachelors degree in engineering, Pharmacy, Chemistry, or a related field. Advanced degree (e.g., MSc, PhD) preferred Languages: Excellent English communication and writing, French or other Languages in addition preferred.