1749 Gmp Jobs - Page 3

Role & responsibilities -To perform the manufacturing process of products and to fill all the quality records in shift as per GMP. (BMR/BPR/ECR/Log Books/etc.) Following the SOP. -To give the requisition for Raw material/Packing material to Raw material store and verification of the same after receipt. -To give requisition for any consumable items to engineering store and verification of the same after receipt. -To give requisition for forms / formats and other quality related documents to QA and submission of the same to QA. -To make sure that all production deviations, non-conformance & accidents are reported along with investigation report. - To schedule training of plant personnel on SOPs, documentation and other cGMP compliances as per ICH Q7 and safety.

Long Description The person should have knowledge in Manufacturing equipments. He should have exposure in equipment’s such as FBE,Fette/KORSCH M/C & auto coater M/C. He should be able to handle equipment trouble shoot in Manufacturing department. He should have exposure in regulatory organization . He must have faced the USFDA ,MHRA & other regulatory audits. He should have the exposure in Caliber QAMS, elog, track wise ,SAP ,WIND ,CDAS & other software. He should have the exposure in process simplification/optimization ,SABA ,elog & SCADA. Competencies Education Graduation in Pharmacy Work Experience 3-6 years of experience in Fette compression machine

Job description Positition- Quality Manager Industry - FMCG Food Experience - 8+ years Location - Ghaziabad Work Summary - The job includes overall product quality, plant quality & packaging quality responsibilities. Ensuring RM, In-process and Finished goods product quality and safety. Including managing and training of QA/QC team to ensure ISO, 3P, FSSAI and other regulatory specifications. Key Role & Responsibilities: 1. Quality Management System (QMS): Oversee and maintain the QMS, ensuring compliance with all quality standards, including ISO, HACCP, GMP, and other industry-specific regulations. 2. Process Monitoring: Monitor all stages of the snacks production process to identify potential quality issues. Implement corrective actions promptly to mitigate any deviations from quality standards. 3. Product Testing and Analysis: Supervise laboratory staff in conducting tests on raw materials, in-process products, and finished product to ensure they meet nutritional, physical, and microbiological standards. 4. Supplier Quality Assurance: Collaborate with the procurement team to audit and evaluate suppliers, ensuring the quality of raw materials aligns with company standards. 5. Documentation and Reporting: Maintain accurate records of quality checks, audits, and corrective actions. Generate reports and present findings to management, providing insights into quality performance. 6. Continuous Improvement: Identify areas for improvement within the production and quality processes. Develop and implement strategies to optimize quality standards and reduce wastage. 7. Training and Development: Train and supervise quality assurance staff, ensuring they are skilled in the latest testing methods and quality control techniques. 8. Compliance and Audits: Prepare for and lead external and internal audits. Ensure all procedures are aligned with regulatory and industry requirements. 9. Customer Complaints and Feedback: Investigate quality-related customer complaints and implement corrective actions. Provide feedback to teams to prevent future issues. Desired Candidate (Professional/ Technical Competencies)- 1. Basic reading, writing 2. Knowledge of food manufacturing operations 3. Knowledge of food technology, food microbiology, safe food handling procedures and food sanitation practices. 4. Knowledge of Good Manufacturing Practices (GMP), HACCP Principles, ISO 9000, FSSC 22000 & other regulations 5. Ability to design and conduct Quality and Food Safety Audits. 6. Ability to apply sound technical principles to root cause analyses, problem- solving and project management. 7. Familiarity with product regulations, food safety, product labelling and nutrition science including FSSAI. 8. Must possess the ability to coordinate and plan strategically. 9. Success Framework Technical Competencies Food Safety, Food Safety & Quality Management System, Business Knowledge, People Management & Development, Problem Solving, Quality Delivery

Ensure current versions of all GMP documents are in use. Prepare, revise, and control SOPs . Implement and enforce (GDP). Conduct internal audits, maintain summaries and CAPA tracking Support in process validation, equipment qualification etc Required Candidate profile Ensure all QA activities comply with cGMP, regulatory requirements & internal quality standards for API & Specialty manufacturing. Contact Mr Deep at 9867038868, Email Id: ops@empowerrecruitments.com

Role & responsibilities Monitoring and data verification for all products and processes Monitor plant activity to ensure compliance to GMPs Maintains QC/QA documents (policies, procedures and records) as required; promote and enforce associate quality and food safety standards Maintain Food Safety and Quality Programs including SQF, allergens, SOPs and other prerequisite programs Conduct random internal inspections. interaction with regulatory and external auditors which can include accompanying the auditor and corrective action plan follow up interaction with plant management which includes assisting departments in researching quality-related issues act as QA department point of contact in the absence of the QA manager monitor and verify QA department responsibilities (inspecting incoming and finish products to ensure conformance to companys standards) Monitor pest control program. Conduct recalls\mock recall. Conduct daily water testing. effectively communicate food safety and quality programs using job instruction training techniques to QA as well as other department associates as needed being an on the work floor participant with production associates (when necessary) maintain Good Manufacturing Practices within the facility other duties as assigned Preferred candidate profile Experience in bakery industry. B.tech. With Food Technology.

B.Sc./M.Sc. with 1–4 years in QC (API). Hands-on with HPLC, GC, UV, and wet analysis. Experienced in raw material, in-process, and finished product testing. Strong in GMP, documentation, and analytical techniques. Required Candidate profile B.Sc./M.Sc. with 1–4 years’ QC experience in API. Proficient in HPLC, GC, wet lab testing, and GMP documentation. Detail-oriented, accurate, and skilled in analytical methods. Perks and benefits GMP GLP plant| Growth| Safety| Compliance| Perks

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

Role & responsibilities Ensuring the cleanliness and housekeeping activities in the laboratory. Ensuring the laboratory safety. Calibration of analytical instruments like High Performance Liquid Chromatography (HPLC) and Gas Chromatography (GC). Analysis of raw material, in-process, finished product and stability samples using HPLC & GC. Analysis of vendor samples as part of vendor qualification. Analysis of cleaning samples using UV & HPLC. Analytical method validation, method transfer and verification analysis as per protocol. Analytical column performance and maintenance. Temperature and humidity daily check in HPLC room. Preferred candidate profile Analytical Chemistry Documentation skills GMP, cGMP/ GLP Skills Interpersonal skills 5S skills( Sort, Straighten, Shine, Standardize& Sustain)

As a valuable member of our team in the pharmaceutical industry, you will be responsible for various key tasks including CAPA, OOS, Deviation management, SOP's generation, and ensuring Validation, GDP, GMP compliance. Your role will play a crucial part in maintaining high quality standards and regulatory requirements. This is a full-time position with a day shift schedule. The ideal candidate should have a total work experience of 1 year, preferably within the pharmaceutical sector. The work location for this role will be in person, providing you with the opportunity to actively engage with the team and processes.,

Alkem Laboratories Limited is an Indian multinational pharmaceutical company based in Mumbai, specializing in the manufacturing and distribution of pharmaceutical generics, formulations, and nutraceuticals across India and over 50 countries globally. Renowned for its top-tier pharmaceutical brands like Clavam, Pan, Pan-D, and Taxim-O, Alkem has consistently secured a position among India's top five pharmaceutical companies. As the IT Business Partner for SCM & Logistics at Alkem, your primary role is to serve as a strategic technology advisor, ensuring that IT solutions are aligned with the company's business objectives for the Supply Chain and Logistics functions. Your responsibilities include optimizing supply chain operations, enhancing logistics processes, and ensuring compliance with pharmaceutical industry regulations. Key responsibilities of the role involve: - Acting as the main IT liaison for Supply Chain, Procurement, and Logistics teams, translating business requirements into strategic IT roadmaps. - Developing and implementing a digital transformation strategy for supply chain operations, focusing on visibility, cost optimization, and automation. - Ensuring IT systems adhere to Indian pharmaceutical regulations, global GxP standards, and data integrity policies to support compliance and operational efficiency. You will be instrumental in: - Leading the enhancement of SAP S/4HANA SCM and IBP solutions to streamline supply chain operations. - Driving warehouse automation through technologies like IoT, RPA, RFID, and AI/ML-based demand forecasting. - Enabling real-time tracking of raw materials, inventory, and finished goods using supply chain analytics and predictive modeling. Your role also includes: - Optimizing inventory management, demand planning, and supplier collaboration through IT-driven insights and analytics. - Supporting serialization, Track & Trace, and regulatory compliance using blockchain or digital ledger technologies. - Improving order fulfillment rates and reducing logistics costs through the implementation of digital tools and automation. Moreover, you will: - Collaborate with SAP partners, IT vendors, and third-party logistics providers to ensure seamless integrations and high system availability. - Work closely with cross-functional teams including manufacturing, procurement, quality, and finance to drive supply chain enhancements. - Establish and maintain robust governance for IT projects, budgets, and vendor SLAs related to supply chain operations. The ideal candidate will possess: - A Bachelor's degree in Computer Science and a Master's degree in Supply Chain Management. - Over 10 years of experience in SCM & Logistics IT leadership roles within the pharmaceutical manufacturing sector. - Proficiency in SAP S/4HANA SCM and any Supply Chain Forecasting tool. - Hands-on experience with automation technologies such as RPA, AI/ML, IoT, and logistics analytics. - Strong knowledge of compliance standards including GMP, GxP, US FDA, EU GMP, CDSCO, and serialization. - Exceptional stakeholder management, project management, and vendor negotiation skills.,

As a Quality Assurance Specialist in the chemical or pharmaceutical industry, you will be responsible for conducting chemical and physical testing on raw materials, in-process samples, and finished products. Your role will involve analyzing and interpreting test results to ensure compliance with quality standards and regulatory requirements. It is essential to document and report testing procedures and results accurately to maintain quality control. In this position, you will be expected to identify and troubleshoot any quality issues efficiently. It is crucial to maintain and calibrate laboratory instruments and equipment, as well as develop and implement quality control processes and procedures. Collaboration with production, warehouse, procurement, sales, and planning teams is necessary to enhance product quality. As part of your responsibilities, staying updated with industry standards and advancements in quality assurance practices is vital. Your experience in a quality assurance role within the chemical or pharmaceutical industry will be beneficial, along with a strong knowledge of analytical chemistry techniques and instrumentation. Familiarity with regulatory requirements and quality standards such as GLP, GMP, etc., is required. You should possess excellent attention to detail and problem-solving skills, along with the ability to work both independently and as part of a team. Strong written and verbal communication skills are essential for effectively documenting procedures and communicating with various stakeholders. A proactive attitude towards delegation and taking on new challenges independently is expected, coupled with a hunger for knowledge and a collaborative approach to teamwork. This is a full-time role that requires a Master's degree and a minimum of 3 years of experience in quality assurance. The position offers benefits such as Provident Fund, and the ideal candidate will be a team player with leadership qualities, committed to making a positive impact in quality assurance practices.,

As the Director of Regulatory Research & Intelligence at Kamet Consulting Group, you will be responsible for leading and developing a team of research consultants in the life sciences and healthcare technology industry. Your role will involve overseeing regulatory intelligence, compliance support, and advisory services for clients in the pharmaceutical and medical device sectors. You will be the key authority for regulatory research activities in India, ensuring delivery excellence, quality control, and strategic insights. Your core responsibilities will include building and mentoring a team of research consultants, setting performance targets, and fostering their professional development. You will also be responsible for ensuring that all research, analysis, and regulatory intelligence meets global quality and compliance standards. Additionally, you will define and evolve the research agenda in alignment with regulatory trends and client priorities, oversee project delivery, and communicate complex regulatory insights to executive audiences. To qualify for this role, you should have an advanced degree in Pharmacy, Life Sciences, Regulatory Affairs, or a related field, with a preference for a PhD or MBA. You should have at least 10 years of experience in regulatory affairs, regulatory intelligence, or compliance within the pharma/medical devices industry, including 5 years in consulting and team management roles. Strong leadership skills, expert knowledge of global and Indian regulatory frameworks, exceptional communication abilities, project management experience, and an entrepreneurial mindset are essential for this position. Desired traits for the role include being well-read on regulatory and scientific literature, culturally adept in global teams, and having high ethical standards and a passion for quality in research and client service. Kamet Consulting Group offers a collaborative and innovative work environment, competitive compensation and benefits package, flexible working arrangements, and growth opportunities for all qualified applicants. Join us to contribute to meaningful technology in the life sciences domain and be part of a team committed to innovation.,

You should be able to stay at Morbe (Panvel) where food & accommodation will be provided. Key Responsibilities: Prepare and dispense Ayurvedic medicines as per doctor's prescriptions. Maintain proper records of stock, formulations, expiry dates, and inventory control. Assist in the preparation of traditional formulations (asavas, arishtas, churnas, kwathas, etc.). Ensure compliance with Ayurvedic pharmacopoeia and GMP (Good Manufacturing Practices). Monitor storage conditions of medicines and raw materials. Guide patients on dosage, timing, and method of taking medicines. Maintain cleanliness and hygiene of the pharmacy area. Collaborate with Ayurvedic doctors and therapists for treatment protocols. Manage procurement and vendor relationships for Ayurvedic raw materials and medicines. 13 years of experience in an Ayurvedic pharmacy or clinic preferred. Job Types: Full-time, Permanent Benefits: Food provided.,

Role & responsibilities Briefing, Assigned the works to all HK staff on cleaning and maintenance tasks on a daily basis. Good knowledge required on Disinfection preparation, Glassware cleaning, Fumigation activities GMP area Labs cleanings as per schedule to monitor on day to day basis Regular Trainings to all the staff Waste Management Monitor proper collection and storage at designated place with proper segration and records SOP preperation / Modification knowledge Monitor and replenish of housekeeping consumables and PPES. Preferred candidate profile GMP/Pharma Experience Mandatory

Career Category Information Systems Job Description Join Amgen s Mission of Serving Patients At Amgen, if you feel like you re part of something bigger, it s because you are. Our shared mission to serve patients living with serious illnesses drives all that we do. Since 1980, we ve helped pioneer the world of biotech in our fight against the world s toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. As a member of the Amgen team, you ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. What you will do Let s do this. Let s change the world. In this vital role you will play a key role in Identity Management to assist in design, implement, and maintain our identity and access management systems. They are responsible for ensuring secure and efficient management of user identities, access controls, and compliance with industry standards. The Sr. Associate IS Engineer will work closely with multi-functional teams to gather requirements and develop solutions that enhance user experience while minimizing security risks. Roles & Responsibilities: The Sr. Associate IS Engineer at Amgen India will participate in requirement gathering sessions, document business processes, and create SDLC work for review. Key responsibilities include: Knowledge of Identity and Access and Role Management applications (IBM ISIM, IBM IGI, Sailpoint IdentityIQ, Sailpoint IdentityNow, Microsoft Identity Manager) will be preferred. Implementing monitoring systems to track user access and changes, ensuring compliance with regulations and company policies. Analyzing business needs for identity and access management (IAM) solutions, including user authentication and authorization requirements. Provide appropriate functional support throughout the life of the projects/products Overseeing the deployment of IAM solutions, including configuration, installation, and customization of identity management tools. Solve problems, respond to issues, and perform repairs as needed. Regularly reviewing and updating IAM systems to enhance security measures and improve user experience. Create and maintain technical documentation such as SOPs, design documents, operational drawings, manuals, etc. This role on occasion might have responsibilities outside of business hours. Travel: International and/or domestic travel up to 10% may be essential. This role requires you to work in shifts. What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Master s / Bachelors degree with 5 - 9 years of Information Systems experience or related field. Functional Skills: Must-Have Skills Familiarity with IAM tools and technologies (e. g. , Okta, Microsoft Azure Active Directory, LDAP). Understanding of security principles, including authentication, authorization, encryption, and compliance standards (e. g. , GMP, SOX). Ability to analyze and interpret complex data to identify issues or validate outcomes. Skills in managing projects, including planning, execution, and collaborator communication. Sharp learning agility, problem-solving and analytical thinking . Good-to-Have Skills Familiarity with cloud platforms (e. g. , AWS, Azure, Google Cloud) and their IAM services. Knowledge of IGA principles, including role-based access control (RBAC) and access certifications. Understanding of data privacy laws and regulations to ensure compliance in identity management practices. Knowledge of incident response procedures and the ability to manage security incidents related to identity management. Professional Certifications Certified Information Security professional (CISSP)(Preferred). SailPoint Identity Now Certification (Preferred). Soft Skills: Excellent analytical and troubleshooting skills. Strong verbal and written communication skills. Ability to work effectively with global, virtual teams . High degree of initiative and self-motivation. Ability to manage multiple priorities successfully. Good social and collaboration skills, with the ability to communicate effectively with business users, technical IT groups, project managers. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now and make a lasting impact with the Amgen team. careers. amgen. com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. .

Career Category Quality Job Description Join Amgen s Mission of Serving Patients At Amgen, if you feel like you re part of something bigger, it s because you are. Our shared mission to serve patients living with serious illnesses drives all that we do. Since 1980, we ve helped pioneer the world of biotech in our fight against the world s toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. As a member of the Amgen team, you ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Position Summary: The AIN Specialist QA plays a critical role in supporting product disposition related tasks across the Amgen Quality Operations Network. The Specialist QA will leverage industry, technical, and quality systems knowledge to provide support of product expiry management processes, product complaints processes, disposition manager training, and fulfillment of disposition related data requests across the network. The position will be responsible for tasks including the key responsibilities documented below and other disposition related job functions. This candidate will primarily work during regular working hours (9 am 6 PM local time) to enable the business in delivering Amgen s mission to serve patients and may lead a shift-based team that provides coverage in support of the Amgen network across multiple time zones. The candidate may need to work outside of his/her routine workday to support business needs and will be responsible for determining the same for their staff. The individual will be required to work from our office located in Hyderabad India (Amgen India-AIN). The candidate will also lead the remote support from AIN to Amgen sites across multiple time zones globally. Key Responsibilities DSI/DS/DP material shelf-life extension - Executing the GMP process to extend expiration dates for clinical and commercial products produced at Amgen. - Updating batch product expiration dates in the Amgen SAP inventory management system. - Evaluating (approve or reject) expiry-SAF forms (expiry stability assessment forms). Disposition Support of Partner Requests - Support requests made by Amgen partners for data and information related to their partnered product batches manufactured at Amgen sites. - Data recovery from systems including, but not limited to, manufacturing execution system electronic batch records, the quality control laboratory information system, the regulatory information management system, and the Amgen enterprise resource management system (SAP). - Uploading and communication of collected data to Amgen partners. COA Generation, special requests after disposition - Generation and provision of Certificate of Analysis (CofA) records for Amgen drug substance, drug product, or final drug product batches. - Uploading and communication of collected documentation to requestor (i. e. Amgen partners, regulatory compliance to support RTQs, process development). Disposition Manager Training - Execution and delivery of quality systems training to new disposition managers across the Amgen network via virtual meetings. - Training subject matter to include use of quality systems applied to execute the disposition process (i. e. ERP/SAP, MES/EBR, ARRS, LIMS, TW, CDOCS, DQMS, Kneat, etc. ) - Maintenance and revision of training document materials in the controlled documents management system (CDOCs). Product Complaints - Execution of the drug substance, drug product, and final drug product complaint full batch record review process. - Assessing electronic batch record (EBRs) documentation in the manufacturing execution system (MES) to identify any potential issues relevant to the complaint. - Recording the results of the complaints batch record assessment in the Bioconnect quality system. Preferred Qualifications - Experience in project management and related systems - Proficiency in technical writing and data visualization tools; experience with Smartsheet, Tableau, or equivalent platforms preferred. - Excellent verbal and written communication skills - Proven ability to lead and collaborate within cross-functional teams in a dynamic, fast-paced setting. - Experience in manufacturing environments Core Competencies - Experience working in a regulated environment with knowledge of Good Manufacturing Practice (GMP) and Good Documentation Practice (GDP) requirements. - Experience working with Quality Systems that may include enterprise resource planning (ERP/SAP), regulatory information management (RIM), controlled document management (CDOCS), change control (QMTS), deviation (DQMS), and quality control laboratory information management systems (LIMS). -Experienced in staff training and development. - Technical Document Drafting and Workflow Ownership Basic Qualifications and Experience : Master s degree with 8-12 years of Pharma and Biotech commercial or clinical manufacturing Quality experience. .

Career Category Quality Job Description QA Technical Specialist The AIN QA Technical Specialist plays a critical role in advancing Quality Assurance initiatives across the Quality Operations Network, with a particular focus on Management Review, Inspections and Compliance, and Technical Writing & Data Analytics. This role provides operational support, technical leadership, and cross-functional collaboration to ensure compliance, continuous improvement, and data-driven decision making in support of the Quality Management System (QMS). The position will be responsible for tasks including the key responsibilities documented below and other technical quality-related job functions. This candidate will primarily work during regular working hours (9 AM 6 PM local time) to enable the business in delivering Amgen s mission to serve patients and may lead a shift-based team that provides coverage in support of the Amgen network across multiple time zones. The candidate may need to work outside of his/her routine workday to support business needs and will be responsible for determining the same for their staff. The individual will be required to work from our office located in Hyderabad India (Amgen India-AIN). The candidate will also lead the remote support from AIN to Amgen sites globally. Key Responsibilities - Management Review Coordinate and manage all logistics related to Site Management Review, including compiling metrics, maintaining and updating Smartsheet trackers, and preparing content. Perform site-level and cross-site trend analysis (as applicable) using key quality metrics; identify trends and collaborate with site stakeholders to implement corrective and preventive actions (CAPA). Lead preparation of Management Review meetings, ensuring comprehensive data presentation creation, documentation of meeting minutes, and follow-up on action items. Inspections and Compliance Support readiness and response for internal and external inspections, including generation of pre-inspection documents such as deviation lists, change controls, and supporting evidence. Actively contribute during inspections by managing information requests, facilitating document electronic retrieval, and preparing responses in collaboration with subject matter experts. Lead Site Master File updates by coordinating content input from cross-functional stakeholders, drafting revisions, and managing review and approval workflows. Technical Writing and Data Analytics Lead authoring and workflow coordination for periodic quality trend reports and related documentation. Generate deviation summary reports to support product and process monitoring efforts, ensuring accuracy and consistency with cGMP standards. Drive quality risk assessments, providing technical leadership in risk identification, analysis, and mitigation planning in alignment with standards. Preferred Qualifications Demonstrated experience in a GMP-compliant environment with working knowledge of inspection protocols, site audits, and quality risk management principles. Proficiency in technical writing and data visualization tools; experience with Smartsheet, Tableau, or equivalent platforms preferred. Strong analytical skills with the ability to interpret data trends and drive improvements based on quality insights. Familiarity with electronic quality systems (e. g. , Veeva, TrackWise, SAP-QM, LIMS) and documentation practices. Excellent verbal and written communication skills, including experience presenting to senior leaders. Proven ability to lead and collaborate within cross-functional teams in a dynamic, fast-paced setting. Core Competencies Leadership in Quality Governance (e. g. , Management Review) Inspection Readiness and Compliance Assurance Quality Data Visualization, Interpretation and Analytics Technical Document Drafting and Workflow Ownership Cross-Functional Stakeholder Engagement Continuous Improvement Mindset Basic Qualifications and Experience: Master s degree with 8-13 years of Pharma and Biotech commercial or clinical manufacturing Quality experience. .

Approve first piece, line clearance, stagewise checks, inproces testing, documentation, report verification, collaborate, GMP Inspection/testing, OCOA, report, complaint/CAPA, traceability, root cause, packaging/shade cards, training, SOP/GMP, audit.

Role & responsibilities Quality Assurance / Quality Controller (FSSAI, FSSC 22000, HACCP compliance required), GMP ETC Preferred candidate profile

At McCormick, we bring our passion for flavor to work each day. We encourage growth, respect everyones contributions and do whats right for our business, our people, our communities and our planet. Join us on our quest to make every meal and moment better. Founded in Baltimore, MD in 1889 in a room and a cellar by 25-year-old Willoughby McCormick with three employees, McCormick is a global leader in flavour. With over 14,000 employees around the world and more than $6 Billion in annual sales, the Company manufactures, markets, and distributes spices, seasoning mixes, condiments and other flavourful products to the entire food industry, retail outlets, food manufactures, food service businesses and consumers. While our global headquarters are in the Baltimore, Maryland, USA area, McCormick operates and serves customers from nearly 60 locations in 25 countries and 170 markets in Asia-Pacific, China, Europe, Middle East and Africa, and the Americas, including North, South and Central America with recognized brands. At McCormick, we have over a 100-year legacy based on our Power of People principle. This principle fosters an unusually dedicated workforce requiring a culture of respect, recognition, inclusion and collaboration based on the highest ethical values. Position Overview Managing, assessing and processing Suppliers approval information. Reviewing/assessing the Approval form and consulting others as required including external parties. Ensuring Vendor Assurance reviews are completed on plan and in accordance with McCormick review standards and external certification requirements. Assessing compliance and safety of raw material/ packaging and working with Category Specialists to determine whether supplier specifications are compliant with McCormick standards; ensuring suppliers close gaps where non-compliance exists. Coordinating Non-Conformance process and Corrective and Preventive Actions with the Supplier and liaising with internal stakeholders as appropriate. Responsible for maintaining audit trail and communications during Non-Conformance processes. Regular communication with Category Specialists and Supplier Quality Managers to ensure team focus is aligned to business requirement. Providing data to category specialists to enable them to produce regular reports of key KPI. Individual contributor reporting to Manager QA and Supplier Quality Rotating Shift Key Responsibilities Supplier Management Supplier qualification, Arranging Raw Material documents and approval, Vendor performance Vendor risk assessments, raw material risk assessments, management of RM/PM specification after approval Interact with suppliers at any and all levels required to establish and maintain effective business relationships Management of supplier issues and CAPA Participate or lead the development of new or revised QA procedures as assigned by the Global Quality and Regulatory. Uploading of procedure , GMP audit report on Intelex Maintain and distribute updated specifications for products as needed. Assist the Quality Team in determining the annual Quality Program training needs. Required Qualifications & Experience Bachelors Degree in Food Science or related field. Min 2 -year experience in Food Industry or similar area, preferably Vendor assurance. GFSI/ISO 22000 internal auditor HACCP internal auditor WHY WORK AT MCCORMICK United by flavor. Driven by results. As a McCormick employee you ll be empowered to focus on more than your individual responsibilities. You ll have the opportunity to be part of something bigger than yourself to have a say in where the company is going and how it s growing. Between our passion for flavor, our 130-year history of leadership and integrity, the competitive and comprehensive benefits we offer, and our culture, which is built on respect and opportunities for growth, there are many reasons to join us at McCormick.

To handle the proposed changes as per the change control procedure. To assess the risk / impact associated with proposed change and to verify the implementation of action plan as per approved change control form. To determine the investigation plan and carry out investigations using appropriate root cause analysis tools, assessing the risk associated with them, to perform the additional studies and to derive the appropriate CAPA. To handle the recommended CAPA and to verify the implementation of recommended actions as per CAPA system and to evaluate effectiveness checks of implemented CAPA. To perform the trend analysis of deviation, change control, complaints etc.. to identify any repetitive event for further evaluation and CAPA. To conduct or be part of team conducting risk assessment of various activities, equipment, systems, etc.. and responsible for assigning the QRM no. To review all labelling related artwork components for products. To prepare artwork information details for new / revised labelling components and submit to QA doc cell for issuance of artwork as per procedure. To review and verify the destruction of old printed packaging materials (vendor and Amneal site) in case of revision of artworks of labelling components. Tracking the actions, review of extensions, verification of documents and closure of actions. Responsible for document handling, issuance, distribution, and retrieval of document. Scanning of documents for regulatory submission To maintain master documents like Site Master File, Validation Master Plan, Quality Manual, SOPs, protocols, reports, Batch Records, specification, method of analysis, drawings, artworks, planners, etc.. Responsible for issuance, archival and retrieval of documents like SOPs, Validation / qualification protocols / reports, Batch records, Specifications, Drawings, Artworks, planners, etc.. To provide BMR/BPR numbering to exhibit, intended and media fill BMR. To provide Batch number to exhibit, commercial, feasibility and medial fill batches. To receive and distribute the product development documents like Master Formula Records, Master Packaging records, protocols (sampling, study, and stability protocols). Issuance of uncontrolled copy / reference copies of master document to user as and when requested by user. To provide requested documents to regulatory affairs department for regulatory submissions (AR or other submissions), whenever required. Artwork management that includes effective the Artwork information details, distribution, retrieval and archival of artwork and all labelling components. To retire the documents as per change control assessment / proposal. Activities other than defined in the Job responsibility are to be done as per the requirement of HOD, by following HODs instruction and guidance. Skills: Monitors production processes in real-time to ensure compliance with specifications and GMP, Batch record review, process monitoring, sampling, quality checks, real-time deviation management.

Are you ready for a new beginning We need your talent, knowledge and dedication to better our world with biology. Our purpose points the way In Novonesis, we know that solutions rooted in biology can help solve humanity s biggest challenges. Since we began more than a century ago, this has been our guide. It s how weve gotten so far. And it s how well impact the future. Now, more than ever, the world needs change. And with biosolutions, the possibilities for transformation are endless. We re here to better our world with biology. NOVONESIS GLOBAL JOB DESCRIPTION Job Title Process Engineer with food Safety speciality Job Description The objective of this role is to review and support in designing the Process Quality and Food safety aspects for the new green field Finish Goods manufacturing plant. Key responsibility areas include: Define and review the requirements for Compliance with QMS, Food safety, GMP standards & FSSAI requirements in line with Novozymes India and global standard. Ensure high health and Safety standards in all the operations including equipmets and operations facilities. Tasks and responsibilities Review Formulation/Standerdisation Process flow PFD against Food safety compliances and support Engineering consultant on the matter. Responsible for Co-ordination with all relevant stake holders from the project Team, Engineering/consultanting company and SCM Operation Teams for the project delivery. Support on best sutaible Plant Layout preparation support to Engineering company for Supply chain Operation Plant. Material and Man Movement plan preparation for new SCM plant in co-ordination with Project Engineering and Management Team. Review the Equipment selction based on GMP stnadards. Compliance to all Food safety/Regulatory/EHS requirements during early design phase. Review of DQ, IQ, HQ & OQ for new equipment s and delivery of the same for the process. Closely work with SCM- India Operations head on complex decisions considering Plant Scalability and Flexibility in Operation of the Plant prior to Design confirmation/Approvals. Ensure the design and layout for sustainable Food excellence and GMP practices in running plant on long term basis. Coordinate and implement relevant trainings, including GMP, Quality, Food Safety and formulation and Supply Chain Operations specific Trainings for new plant operations. Support in process development and include Quality aspect while SOP preparation. Basic Qualifications B Tech Chemical / Bio Tech with 5 to 8 years of Experience in Food Industry. Additional qualification in FSMS, FSSC 22000, QMS and with Auditing experience is added advantage. Supervisor responsibilities No Reporting lines Head of Supply Chain Operations India Physical requirements ( For North America positions ONLY) NA Candidate profile Candidate should have Experience in working with Global teams and stakeholders Knowledge FSMS, QMS and Auditing Experience is added advantage. Challenges in position You can create an impact by Ensuring the plant design for high level of Safety standards and 100% Compliance to Food Safety and Quality Unlocking your passion by implementing new Digital technologies and processes to ehnace the food excelenece. Language of job advertisement (English default) English Could our purpose be yours Then apply today! At Novonesis we commit to an inclusive recruitment process and equality of opportunity for all our job applicants. We recommend you not to attach a cover letter to your application. Instead, please include a few sentences in your resume/CV about why you are applying. To ensure a fair recruitment process, please refrain from adding a photo in your resume/CV. Novonesis is dedicated to fostering a unique community by embracing and respecting differences. We make all employment decisions based on business needs, ensuring that every individual can thrive, regardless of identity or background such as ethnicity, religion, gender, sexual orientation, age, disability, or veteran status. Want to learn more Learn more about Novonesis, our purpose, and your career opportunities at novonesis.com Not the right fit for you Even if this job isnt the right fit for you, perhaps you know someone who might find it interesting. If so, please feel free to share the job link and encourage them to apply. Thank you for your referral! Please check out our other open positions. The right fit for you could just be a few clicks away. Stay alert: Avoid recruitment scams At Novonesis, we are committed to maintaining a safe and transparent recruitment process. Please be aware of potential scams targeting job seekers and take note of the following: Novonesis will never ask for sensitive personal information, such as bank account details, Social Security numbers, or passwords, at any stage of the hiring process. Novonesis does not make employment offers without conducting interviews with candidates. If you receive suspicious communication claiming to be from Novonesis, please do not share any personal or financial information. We encourage you to verify the legitimacy of the message by contacting us directly through our official channels.

Sl. No Responsibilities To follow-up the instructions of Assistant Manager/Dy. Manager/Sr. Manager - Production and carry out shift production activities as per the plan. Maintains the Logbook as per shift activities. Ensures all the raw materials are available on time for the batches planned and all the required batch sheets are made available. Shall be responsible for making entries in all batch records and other Production related documents and ensure that the recordings are done as and when the operations are completed. Coordinates with Engineering department for the completion of maintenance jobs on time and coordinates with QC on in-process and finished product analysis. Shall follow the GMP and Safety norms in the plant. Shall follow the relevant Standard Operating Procedure at various stage of operation. Attending EHS training Programme. Shall co-ordinate Production Assistant in maintaining stipulated parameters (like temperature, pH, pressure etc.) during the batch processing. Shall record any abnormality or deviations observed during the processing. Shall maintain Good House Keeping in plant and cleanliness of the equipment. Preparing the instructions (BPCR, BCLR, SOP Check lists etc.) for production of intermediates or APIs according to written procedures. Producing APIs new and, when appropriate, intermediates according to pre-approved instructions. To ensure that production facilities are clean and when appropriate disinfected. To ensure that the necessary calibrations are performed and records kept. To ensure that the premises and equipment are maintained and records kept. To verify the environmental conditions of the controlled area. To have performance control over the contract workmen. To verify the contract worker s health, hygiene conditions for working in controlled areas. To allocate the task to the casuals and have performance control. Responsible to handle tasks other than above assigned by reporting persons time to time.

Job Summary: We are seeking a meticulous and detail-oriented Quality Checker to join our packaging artwork team. The role requires thorough experience in reviewing packaging artworks for compliance, consistency, and accuracy. The ideal candidate should be familiar with Adobe Creative Suite tools and artwork validation workflows in regulated industries like pharmaceutical or CPG/FMCG domains. Role & responsibilities Verify packaging artwork files against technical briefs, regulatory standards, and brand guidelines. Check alignment, font consistency, spelling, and layout accuracy in Illustrator and InDesign files. Compare artwork revisions using visual comparison tools or side-by-side manual methods. Validate correct Pantone, CMYK, and black/white color usages as per print specifications. Ensure images and logos are high-resolution, color corrected, and placed correctly. Track version history and ensure all changes are properly implemented and approved. Collaborate with designers, regulatory, and project managers to resolve discrepancies or errors. Support final quality checks before prepress or print delivery. Document QA feedback, maintain checklists, and prepare reports on defects or non-conformities. Support towards RCA/CAPA Preferred candidate profile 3+ years of experience in packaging artwork QA or Quality control with process improvement suggested based on the errors identified against Designers/Artworkers Strong knowledge of Adobe Illustrator, InDesign, and Acrobat for visual checks (Mandatory) Familiarity with color formats (Pantone, CMYK, RGB) and prepress compliance Ability to detect layout errors, font mismatches, bleed/trims, and inconsistencies Good communication skills for documenting and escalating issues Understanding of regulatory packaging standards (especially in Pharma or CPG/FMCG) Proficiency in using markup tools, comparison software

Your role will include, but is not limited to: Preparation of plant equipment layouts, process flow diagrams, equipment sizing P IDs. Preparation of Specifications, for Process Equipment, Utility Equipment Warehouse Equipment etc. Mass Energy balances to calculate Utility Load requirement. Knowledge of instrumentation Control requirement Preparation of plant process control Philosophies. Provide required process input to Instrumentation team for instrument process data sheets. Input to project schedules and monitoring tasks to meet milestones during each phase. Develop documentation, diagrams, and specifications to meet project requirements and regulatory standards. Prepare scope of work documentation for use in project planning. Participate in project reviews to enable ongoing status tracking and reporting. Prepare review project documents i.e. DQ, IQ, OQ PQ Qualifications, FAT/SAT protocol reports etc. Ensure adherence to industry standards and best practices in Process designing. Adhering to cGMP guidelines and work as per Arcadis SOP/Work instructions. Compliance to SHE Sustainability Performs the tasks within the agreed-upon budget and schedule. Qualifications Mandatory: Bachelor s degree in engineering (chemical, mechanical, industrial or similar). 5-8 years of experience as a process engineer in a design consultancy or GMP manufacturing environment. Knowledge of process analysis process modelling. Working knowledge of process safety, risk assessment and compliance with regulatory standards. Good project management skills with the ability to prioritize tasks and meet deadlines. Effective communication and interpersonal skills to collaborate with cross-functional teams and stakeholders. Ability to manage multiple projects simultaneously and meet deadlines in a fast-paced environment. Nice to have: Master s degree in process engineering or a related field. Professional certification in process engineering or related areas. Experience with process automation and control systems. Knowledge of process simulation software and computer-aided design (CAD) tools. Solid understanding of quality management systems, such as ISO standards. Experience of sterile processing Knowledge of Hazardous Area Classification Experience of high potency pharmaceuticals Experience of both small molecule and large molecule process design