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2 - 7 years

9 - 13 Lacs

Ahmedabad

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LOCATION: Ahmedabad REPORTS TO: Sr Quality Manager, APAC DIRECT REPORTS: 3 WORKPLACE TYPE: On-site The Quality Manager , India will take the responsibility for leading the India quality functions and personnel safely, responsibly, consistently, and cost-effectively to achieve world-class Quality as a competitive differentiation to support India Business Growth. Provide leadership and guidance to the Internal plant quality Tollers Quality teams to ensure the good implementation of Core GMP practices which relevant to current regulatory standards must to be followed to maintain industry global quality standards and also implement the key components of IPS Pillar in the Quality functions. Develop, coach, and support the site and country Quality team to inspire potential, deliver strong performance, and build great talents. Identify and lead the Quality improvement projects supporting the Quality and Operations groups and be responsible for India Quality MIS reports to India Business Leadership and Regional Quality Core Responsibilities: Optimize the Ingredion India Quality Management Strategy and Roadmap continuously and drive solid implementation in each site, including the Tollers. Coordinate with Regional Quality leadership, Global Pharma Regulatory QMS leadership, Global Regional Quality documentations team to provide guidelines for India quality system to all Ingredion sites to satisfy certification, regulation, corporate, and increasingly complex and diverse customer requirements continuously while improving the agility of the process to meet the business requirements on the premise of current regulations compliance and industry standards. Provide leadership and guidance to the plant operations, manufacturing and quality teams on the execution of the IPS Quality Pillar Ingredion Global Quality Standard including Pharma QMS to deliver continuous quality improvements such as First Pass Compliance (FPC) metrics, customer complaints, and internal/external audit results etc. Be the main contact for Plant Quality managers to escalate Quality issues, assimilate complex information, data, and processes, give insights into the issues, and guide the plant team to move precisely and efficiently. Provide quality improvement suggestions to India Manufacturing leadership and share the quality strategic improvements with India business leadership team on regular/need basis. Meet with the Plant Managers on a regular basis to discuss current issues, and support required, and align priorities as well as employee development strategies. Collaborate with regional/global supplier quality to manage raw material compliance and ensure supplier conformance and prevent quality issues caused by raw materials or goods manufactured by Tollers. Drive and support the investigation of customer complaints timely and reduce the customer complaint rate year by year. Maintain contacting both internal and external networks to identify, introduce, and drive for the implementation of best practices from other locations/businesses related to Pharma excipients Quality and Food Safety management. Lead Quality team to seek CI opportunities and drive innovation culture to improve quality performance, work efficiency, and reduce manufacturing cost continuously. Oversee the EHSS management of Quality function to achieve all EHSS targets and ensure zero recordable incidents continuously. Build great Talents in the Quality team. Flexible to meet the increased demands of the role. Qualified candidates will have: Bachelor s or Master s Degree in Science preferably Pharmacy/Analytical science/Organic Chemistry/Food Science Engineering/Technology or similar Minimum of 10 years of experience in quality assurance management in the Excipient/API/Bulk drugs industry Min 5 years of team management and development experience Working in a global MNC with Pharma GMP and FSSC exposure will be an advantage. Maintain solid knowledge of governmental regulations related to excipients. Deep understanding of CGMP standards of Pharma excipients as per IPEC-PQG GMP training/exposure and or ICH/ USFDA/MHRA/ PICs /EXCiPACT. Good customer interaction experience. Good strategy thinking and strategy development skills on quality. Strong leadership skills and excellent communication and presentation skills. Literate in MS Office software. Good command of English in both written and spoken. High commanding work efficiency with people management, commitment, perseverance under pressure, and ability to deal with challenging situations. Desirable requirements: Working experience in the food industry with an understanding of food regulations, and certification standards such as ISO9001, FSSC22000, BRC, HACCP, etc. will be preferred. Be good at the RCA tools application and could act as an RCA facilitator. B2B business with international customer group working experience. Required behaviors and skills: Interpersonal effectiveness - Establish a constructive and cooperative relationship with colleagues and a climate of openness and trust. Taking ownership - Demonstrate a high level of honesty, integrity, and commitment to one s profession and accept responsibility for the consequences of one s and their team s decisions and actions. Business acumen - Open mind, understanding the critical points of the business, well-balanced Commercial and Operation team s requirements. Timely response, strong problem-solving skills, and good at communication. Growth mindset - Willing to learn and grow through taking more/extra challenges. Relocation Available: Yes, Within Country

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3 - 10 years

6 - 7 Lacs

Baddi

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Having adequate knowledge of Sampling, Testing of Raw material, Packing Material, Finish Product, Validation and Stability samples. Having adequate knowledge of Laboratory Instruments and equipment s Calibration, Maintenance/External calibration. Having adequate knowledge of Preparation of laboratory chemicals, Reagents, test solution, and Volumetric solution. Having adequate knowledge of Reference, Chemical and Working standard management i.e., Working Standard qualification and support in working standard management. Having adequate knowledge of Data entry in SAP. Having adequate knowledge of operation and trouble shoot of HPLC/UV/IR and other QC analytical instruments and its software. Having adequate knowledge of data entry management in inventory/Information management software of QC like LIMS software. Having adequate knowledge of preparation of the QC documents like SOPs, Protocols and general documentation. Having adequate knowledge of Pharma Industry Guidelines and Pharmacopoeias. Having exposure of regulatory audit and GDP/DI compliance. Having adequate knowledge of GLP / GMP requirements.

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7 - 11 years

9 - 13 Lacs

Bengaluru

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Skill required: IX Intelligent Asset Management Operations - Asset Data Management Designation: Asset Performance Mgmt Specialist Qualifications: Any Graduation Years of Experience: 7 to 11 years What would you do? Role:Occupational HygienistThe Occupational Hygienist serves as a technical expert on industrial hygiene, providing guidance on regulatory requirements, safety compliance, and best practices while analysing complex data to inform occupational exposure limits and support litigation and industry studies. This role will support occupational hygiene programs across Client assets, coordinating health resources for projects and turnarounds, and offering direct occupational health support to business units. The role is part of the Health, Safety and Environmental team at the Client. What are we looking for? Bachelor s degree in industrial hygiene, occupational health, safety, or a related field from a recognized (AICTE) university Minimum of 5 years of experience in occupational hygiene, preferably in the oil and gas industry. Proficient in using various OH software and analysis of health and safety data. Roles and Responsibilities: Act as a technical resource and expert consultant for Client by being knowledgeable in regulatory industrial hygiene requirements, including interpretation, applicability, best practices, and guidance. Provide counsel and support for safety and health compliance concerns, including appropriate management and workforce engagement. Analyze complex data sets for detailed studies, including support for litigation, industry studies, and to inform internal occupational exposure limits (OEL) development. Provide guidance, implement and manage Client occupational hygiene and occupational health programs across international operations and corporate organizations to recognize, eliminate, and control occupational health hazards and diseases. Provide occupational health support to business units and plan, communicate, and remotely monitor field activities including turnaround, project, and/or routine operations. Provide input into Hazard Identification (HAZIDs), design of exposure assessments, occupational health equipment calibration and repairs, noise surveys, legionella testing, radiation checks, and hazard communications as needed. Audit performance against requirements and recommend practical corrective actions or solutions. Qualifications Any Graduation

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2 - 7 years

3 - 4 Lacs

Amroha, Gajraula

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experience into executing CALIBRATION, also be familiar with computerized systems, plant equipment, laboratory equipment, facilities, utilities, process control systems, for our clients in support of GMP/FDA requirements. Prior calibration services experience is a plus.

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5 - 7 years

10 - 15 Lacs

Pune, Mumbai, Hyderabad

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This Role is responsible for implementing CMC regulatory strategies for assigned pharmaceutical products in accordance with global regulations, guidance s and defined regulatory strategies. He would even be responsible for the preparation and review of information required for development of regulatory CMC dossiers for commercial products. Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance across regulatory agencies. We are an international network on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world. Your role at our organization is integral to helping the world meet new breakthroughs that affect generations to come, and we re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. Primary responsibilities include, but are not limited to: Regulatory Responsibilities: Provide input to global product and project regulatory strategies by performing assessments of CMC changes, identifying global regulatory requirements and critically evaluating supporting documentation to assess acceptability and identify potential risks. Execute regulatory strategies by leading the development, authoring and review of CMC submission components and documentation to support post-approval supplements/variations, annual reports, registration renewals and responses to health authority questions per established business processes and systems. Liaise with global CMC, Our Manufacturing Division and external partners to support compliant execution of change management and conduct all activities with an unwavering focus on regulatory conformance. Assess and communicate potential regulatory risks and propose mitigation strategies. Deliver all regulatory milestones for assigned products across the product lifecycle Identify and communicate potential regulatory issues to GRACS CMC management, as needed Technical Skills: Experience in reviewing scientific information to assess technical merits and suitability of scientific rationale to ensure information is presented clearly and conclusions are adequately supported by data. Demonstrated oral and written communication skills and the ability to communicate issues in a succinct and logical manner. Strong listening skills. Demonstrated understanding of related fields (eg, pharmaceutical manufacturing, analytical testing, and quality assurance). Proficient computer skills and previously demonstrated ability to operate in electronic document based GMP systems Leadership Skills: Demonstrated ability to generate innovative solutions to problems and effectively work with and communicate to key stakeholders. Demonstrated flexibility in responding to changing priorities or dealing with unexpected events. Capability to handle multiple priorities and balance work to achieve business goals. Demonstrated effective leadership, communication, and interpersonal skills Qualifications & Skills Bachelor s in Science, Engineering, or a related field (advanced degree preferred). Fields of study include Pharmacy, Chemical Engineering, Biology, Microbiology, Virology, Molecular Biology, or Biochemistry Minimum 5 - 7 yrs of Industry Pharmaceutical industry experience out of 4 years experience in managing CMC Regulatory submissions for small molecules/vaccines/biologics The candidate may be required to travel to other CMO sites on a need basis.

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10 - 12 years

20 - 25 Lacs

Pune, Mumbai, Hyderabad

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This Role is responsible for implementing CMC regulatory strategies for assigned pharmaceutical products in accordance with global regulations, guidance s and defined regulatory strategies. He would even be responsible for the preparation and review of information required for development of regulatory CMC dossiers for commercial products. Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance across regulatory agencies. We are an international network on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world. Primary responsibilities include, but are not limited to: Regulatory Responsibilities: Provide input to global product and project regulatory strategies by performing assessments of CMC changes, identifying global regulatory requirements and critically evaluating supporting documentation to assess acceptability and identify potential risks. Execute regulatory strategies by leading the development, authoring and review of CMC submission components and documentation to support post-approval supplements/variations, annual reports, registration renewals and responses to health authority questions per established business processes and systems. Liaise with global CMC, Our Manufacturing Division and external partners to support compliant execution of change management and conduct all activities with an unwavering focus on regulatory conformance. Assess and communicate potential regulatory risks and propose mitigation strategies. Deliver all regulatory milestones for assigned products across the product lifecycle Identify and communicate potential regulatory issues to GRACS CMC management, as needed Technical Skills: Experience in reviewing scientific information to assess technical merits and suitability of scientific rationale to ensure information is presented clearly and conclusions are adequately supported by data. Demonstrated oral and written communication skills and the ability to communicate issues in a succinct and logical manner. Strong listening skills. Demonstrated understanding of related fields (eg, pharmaceutical manufacturing, analytical testing, and quality assurance). Proficient computer skills and previously demonstrated ability to operate in electronic documentam based GMP systems Leadership Skills: Demonstrated ability to generate innovative solutions to problems and effectively work with and communicate to key stakeholders. Demonstrated flexibility in responding to changing priorities or dealing with unexpected events. Capability to handle multiple priorities and balance work to achieve business goals. Demonstrated effective leadership, communication, and interpersonal skills Qualifications & Skills Bachelor s in Science, Engineering, or a related field (advanced degree preferred). Fields of study include Pharmacy, Chemical Engineering, Biology, Microbiology, Virology, Molecular Biology, or Biochemistry Minimum 10 - 12 yrs of Industry Pharmaceutical industry experience out of 6 years experience in managing CMC Regulatory submissions for small molecules/vaccines/biologics. The candidate may be required to travel to other CMO sites on a need basis.

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2 - 5 years

3 - 7 Lacs

Ahmedabad

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ql-editor "> We are seeking a meticulous and motivated QA Analyst to join our team. The QA Analyst will be responsible for ensuring the quality and reliability of our systems and processes through comprehensive audits, testing, and compliance with regulatory standards. The ideal candidate will have a strong attention to detail, excellent communication skills, and the ability to work collaboratively in a dynamic environment. Key Duties and Responsibilities: Perform Quality Assurance Audits: Conduct system process audits to identify inconsistencies and areas for improvement. Quality Standards Development: Develop, review, and update quality standards to align with industry best practices. Testing Processes: Create, update, and evaluate test cases; contribute to both manual and automated testing efforts to ensure optimal system performance. Documentation: Develop, update, and maintain software documentation, standard operating procedures (SOPs), validation documentation, and other technical materials. Regulatory Compliance: Ensure adherence to relevant regulatory requirements, including but not limited to CSV, 21 CFR Part 11, EU regulations, GxP, and GMP standards. Skills and Qualifications: Quick learner with the ability to adapt to new tools and processes. Strong verbal communication and coaching skills. Excellent written communication skills for clear and concise documentation. Proven ability to work effectively in a team environment. Goal-oriented with a focus on achieving the mission and vision of the organization. Exceptional time management skills to prioritize tasks and meet deadlines. Flexible working approach, capable of adapting to changing project requirements and timelines. Preferred Experience: Experience with manual and automated testing tools. Familiarity with quality assurance frameworks and methodologies. Knowledge of regulatory compliance standards in relevant industries.

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2 - 10 years

3 - 6 Lacs

Ahmedabad

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ql-editor "> Job Summary We are looking for a versatile Analyst focusing on our In Vitro segment with experience in one or more of our in vitro services, such as IVRT, IVPT, in vitro bioequivalence (BE) studies, BCS biowaivers, enteral feeding tube studies, or in vitro statistical analysis. While expertise in all these areas is not required, candidates should have a strong foundation in in vitro techniques, regulatory guidelines (eg: FDA, EMA), and data interpretation to support pharmaceutical product development. Key Responsibilities Conduct or support one or more of the following: In vitro release testing (IVRT) and in vitro permeation testing (IVPT) for pharmaceutical formulations. In vitro bioequivalence studies and BCS biowaiver studies as per regulatory standards. Enteral feeding tube studies to assess drug administration compatibility. Analysis and interpretation of data from in vitro studies, applying statistical methods where required. Ensure compliance with FDA, EMA, ICH, and USP guidelines in laboratory procedures. Prepare and review study protocols, scientific reports, and regulatory documentation. Collaborate with cross-functional teams, including regulatory affairs and bioanalytical scientists. Maintain laboratory equipment, follow SOPs, and ensure GLP/GMP compliance. Basic understanding of statistical analysis for in vitro studies is a plus. Qualifications Skills Education: Bachelor s, Master s or Ph.D. in Pharmaceutical Sciences, Biopharmaceutics, Analytical Chemistry, or a related field. Experience: At least 2 years of experience in any in vitro research area, preferably within a CRO or pharmaceutical company. Soft Skills: Strong analytical and problem-solving abilities. Excellent written and verbal communication skills. Ability to learn quickly and adapt to new in vitro methodologies. Why Join Us Work with a leading CRO specializing in diverse in vitro research areas. Gain exposure to multiple in vitro techniques and expand your expertise. Collaborative and growth-oriented work environment. If you are eager to develop expertise in in vitro research and contribute to high-impact pharmaceutical studies, we encourage you to apply!

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2 - 5 years

3 - 6 Lacs

Mumbai

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ql-editor "> Purpose of the job: To Identify and evaluate new products - Business case analysis with complete product-market level detailing in targeted therapeutic areas To Analyse market data sources for market trends, revenue by products to develop evaluate competitive landscape and build the projections for next 5 years To Identify, evaluate and execute In-Licensing/out-licensing deals for Target markets and evaluation of market expansion To Outsource / tech transfer / co-development deal making after legal, regulatory, and financial due diligence Working with different geographical teams to understand market needs, evaluate and extend on-ground support towards pricing, order volumes, registration Close coordination with internal stakeholders and manufacturers to execute the NDAs, commercial supply agreements, contract development agreement, to meet the dossier requirements, GMP assessment and country specific registration requirements Scouting of new manufacturers in global pharmaceutical market, attending CPHI, Pharmaceutical conferences, create the product-manufacturers database which would help to venture into collaboration based on product market specific requirements in future Identify the tender opportunities and participate in tenders with competitive quotes. Thorough analysis on pricing trends, manufacturers, competitors and adherence to tender requirements, delivery terms and quality compliance Building the portfolio for pharmaceuticals, Biosimilars, OTC Critical experience: Should have experience in dealing of pharmaceutical products for Business Development/Marketing/ Projects Management / New product development / Out-Sourcing in a repute company/ Good industry knowledge and network with industry suppliers Minimum Education: B Pharma/M.Pharm / MBA /PGDPM qualification will be of advantage. Key Performance area: Tasks: Market Analysis Responsible for identification and evaluation of products (finished goods) as per market need with thorough rationalization. Create business case for potential products. Carrying out market research analysis on basis of primary secondary research Sourcing of Vendor / In-Licensing Should be able to source Products for target market for Indian/International supplier as per need. Play a role of point of contact between suppliers and end customers. Should have knowledge of finished product suppliers Coordination for Regulatory compliance Understanding on regulatory requirements, screening of manufacturers based on product/ plant qualification, Coordination with internal stakeholders and business partners to meet the dossier requirements, GMP assessment and country specific registration requirements Tender opportunity identification and execution Responsible for Identification of tender opportunities and participate in tenders with competitive quotes. Thorough analysis on pricing trends, manufacturers, competitors and adherence to tender requirements, delivery terms and quality compliance Alliance Management / Cross functional coordination Work with internal stakeholders and business partners for Country specific requirements, finance team, logistic, packaging etc. Execution of Confidentiality and Commercial supply agreements, negotiation on the terms and conditions to safeguard the interest of organisation.

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4 - 8 years

10 - 14 Lacs

Trivandrum

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Requisition ID: 33446 At Terumo Blood and Cell Technologies, our 7,000+ global associates are proud to come to work each day, knowing that what we do impacts the lives of patients around the world. We make medical devices and related products that are used to collect, separate, manufacture and process various components of blood and cells. With our innovative technologies and service offerings, we touch a patient s life every second of every day and are committed to continuing to increase the number of patients we serve. With some of the best and brightest minds in the industry, an unmatched global footprint, comprehensive benefits and a distinct culture, Terumo Blood and Cell Technologies is a great place to work, grow and be part of a team that is focused on making a difference. Consider joining our team and unlock your potential. JOB TITLE: Laboratory Scientist JOB SUMMARY Under general supervision and as a member of a Scientific Affairs team, independently leads/executes research, scientific, technical programs, projects and/or experiments of blood Lab. Develops procedures, programs and strategies to establish the validation/verification protocols and writing the reports and procedures to comply with international regulatory and standard requirements. Ability to work as part of a team as well as work in laboratory to complete a variety of tests, analyses, or production and research activities involving chemical, biochemical and biological samples, specimens, and products. ESSENTIAL DUTIES Developing procedures, programs and strategies to ensure FDA, AABB, EU and ISO requirements. Standardize lab procedures globally within the organization. Provide protocol support for global laboratory sites. Work to complete a variety of tests, analyses, or production and research activities involving chemical, biochemical and biological samples, specimens, and products. Establish capabilities and cost matrix for laboratories Supports departmental programs to improve productivity, quality, customer service, costs, etc. Develops and maintains systems for tracking projects and continuous improvement activities. Adequately participates in and supports the problem-solving needs of operating groups for all areas of the company and the development of new products. Preparation, support, and resolution of internal and external laboratory audits. Generates position statements on specific topics of Company interests. Reviews physical and equipment requirements for the laboratory. Regularly assesses short and long-term needs and prioritizes equipment purchases. Foster communication and collaboration among global laboratories. OTHER DUTIES AND RESPONSIBILITIES Maintains general knowledge of industry and Company regulatory and scientific quality standards and applies this knowledge to the completion of all projects. Develops and maintains pertinent documentation and procedures for the technology area according to industry, vendor, and company standards. Actively involves in laboratory inventory management, quality assurance programs and overall laboratory management. Familiarity with GMP/GLP practices and ISO standards for blood bags. Demonstrates required competencies and grow in the Leadership Competency Model. MINIMUM QUALIFICATION REQUIREMENTS Education Masters in any Life science stream or PhD in any Life science stream Experience Minimum 5 years of experience in industry/clinical/research laboratory settings for post graduate candidates. 1 year (preferred) experience in industry/clinical laboratory settings for Ph D candidates. Skills Ability to develop knowledge in chemistry, biological, environmental, or engineering sciences as they relate to the technical area of the business. Ability to analyze problems limited to moderate levels of complexity and assist in the design and implementation of solutions. Proficient in molecular biology, and biochemical techniques. Good working experience with flow cytometer (mandatory). Good knowledge of Microsoft packages. Deep understanding of technical principles in assigned areas. Demonstrated working knowledge of statistical operations and analysis. Demonstrated experience in science writing Good working knowledge of good laboratory practices. Demonstrated ability to communicate effectively both verbally and in writing. Patience, decisiveness and meticulousness. A desire to contribute to patient care and treatment. A responsible and mature approach to their work. Accuracy, with good attention to detail. A systematic approach to tasks and the ability to follow instructions and set procedures. PHYSICAL REQUIREMENTS Typical Office Environment requirements include: reading, speaking, hearing, close vision, walking, bending, sitting, and occasional lifting up to 20 pounds. The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties. Terumo Penpol is part of Terumo Group and is headquartered in Thiruvananthapuram, Kerala. As India s largest blood bag manufacturer, we provide a comprehensive range of blood collection, storage and processing solutions for blood centers, hospitals and therapeutic apheresis centers in India and abroad. Our high-quality products touch the lives of patients in over 80 countries across the world. True to our mission of contributing to society through healthcare, our award-winning Corporate Social Responsibility initiatives reinforce our organizational values and culture. Firmly rooted in core values collectively termed as the Associate Spirit , our work culture fosters an environment conducive to growth and continuous learning. People are our greatest asset, and we place as much importance in their professional development as in the research and development of our products.

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12 - 13 years

12 - 13 Lacs

Mumbai

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About Apotex Inc. Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 7,200 people worldwide in manufacturing, RD, and commercial operations. Apotex medicines are accessible to patients in more than 75 countries globally. Through vertical integration, the Apotex group is focused on the development and sale of generic, biosimilar and specialty products. For more information visit: www.apotex.com . Job Summary Reporting to the General Manager, QA 3rd Party Ops, India, this role is responsible for supporting the Quality Systems required to ensure that Apotex meets its regulatory and GMP compliance obligations for Apotex Suppliers. Support Managers with compliance activities for Third Party Organizations and Customer Operations. Responsible for executing GMP activities related to the corporate governance of Suppliers to global Apotex Manufacturing Sites. Job Responsibilities Negotiates with external suppliers on the provisions of the customer Quality Agreements. Makes decisions in consultation with the Manager, External Quality on the respective quality responsibilities to ensure both parties are compliant to GMP and meet Apotex internal standards. Responsible for ensuring that Quality Agreements are in place and current for vendors supplying to multiple Apotex Manufacturing Sites. Liaise directly with Apotex Suppliers in negotiating Supplier Quality Agreements and escalate to management when roadblocks occur. Monitor and track status of Quality Agreements. Provides support to External Quality Managers, in reviewing GMP Quality Documents that form part of Product Compliance Files. Reviews third party manufacturer s Stability protocols and Summary Reports. Reviews and approves third party manufacturer s Change Controls. Provides support to Customer Operations Manager, in processing customer requests for products manufactured by Apotex for Third Parties. Works as a member of a team to achieve all outcomes. Performs all work in accordance with all established regulatory and compliance and safety requirements. Performs all work in compliance with our Code of Conduct and Business Ethics, and related policies and with the legal and regulatory requirements that apply to our job activities. Operates in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements. Performs all work in support of our Corporate Values: Collaboration, Courage, Perseverance, and Passion. All other relevant duties as assigned. Job Requirements Education Minimum B.Sc. in Biology, Microbiology, Chemistry, Pharmacy or a related science Knowledge, Skills and Abilities Must be familiar with overall pharmaceutical manufacturing and quality systems/process. Good knowledge of global GMPs and QA/QC systems associated with the manufacture of human drug products. Excellent written and verbal English communication skills. Excellent interpersonal skills and ability to relate well to internal and external customers. Experience Minimum 8 years experience in the pharmaceutical industry with relevant QA/QC/Mfg experience, preferably with multiple dosage forms. Experience with international regulations (e.g. Health Canda, US FDA, EU) is an asset. Must be detail oriented, accurate and reliable. Demonstrate personal leadership and accountability. Excellent organization skills and analytical thinking. At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported. Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.

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7 - 9 years

30 - 40 Lacs

Mumbai

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1. Strategic Leadership: Develop and execute the product development strategy for the private label medicine brand. Identify market trends and opportunities to drive product innovation and differentiation. Collaborate with senior leadership to align product development goals with overall business objectives. 2. Product Development: Oversee the end-to-end product development process, from concept to commercialization. Manage the development of new pharmaceutical formulations, ensuring compliance with regulatory standards. Lead quality assurance, regulatory affairs, and manufacturing teams to bring new products to market. 3. Market Research and Analysis: Conduct market research to identify customer needs, competitive landscape, and potential product gaps. Analyse data to inform product development decisions and prioritize initiatives based on market demand and business potential. 4. Project Management: Lead cross-functional project teams, ensuring timely and successful product launches. Develop and manage project timelines, budgets, and resources. Monitor project progress, identify risks, and implement corrective actions as needed. 5. Quality and Compliance: Ensure all products meet stringent quality and regulatory standards. Collaborate with regulatory affairs to navigate the approval process for new products. Implement and maintain robust quality control procedures throughout the product development lifecycle. 6. Partnership and Collaboration: Establish and maintain strong relationships with key stakeholders, including suppliers, contract manufacturers, and external partners. Negotiate contracts and manage partnerships to support product development goals. 7. Team Leadership: Build and mentor a high-performing product development team. Foster a collaborative and innovative work environment that encourages professional growth and development. Desired Skills and Expertise: Bachelor s degree in Pharmacy, Pharmaceutical Sciences, Chemistry, or a related field. An advanced degree (MBA, PharmD, or equivalent) is preferred. Minimum 7 years of experience in pharmaceutical product development, with a focus on generic or private label medicines. Proven track record of successful product launches in the pharmaceutical industry. Strong knowledge of FDA regulations, GMP, and other relevant regulatory requirements. Excellent project management skills, with the ability to manage multiple projects simultaneously. Strong analytical and problem-solving skills. Exceptional communication and interpersonal skills. Demonstrated leadership experience with the ability to inspire and manage a team.

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5 - 7 years

4 - 8 Lacs

Mumbai

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The Asst Manager- QA/AC plays a critical role in maintaining the quality of new pharmaceutical products within the organization. This position requires a detail-oriented individual with a strong understanding of GMP practices, Quality, and legal compliances, and pharma regulations. The Asst Manager- QA/QC will collaborate with cross-functional teams and internal and external stakeholders, coordinate project activities, and ensure adherence to timelines and quality standards, and compliances for new product development in the organization. Responsibilities: Evaluate the various manufacturing facilities by conducting the facility GMP audits/inspections as per regulatory guidelines and approve the facility post proper due diligence and publish an audit report for compliance if required. Evaluate the tech pack (Quality documents/dossier) of the shortlisted finished formulations across various dosage forms manufactured by the manufacturer to ensure the pre-requisite quality requirements to approve the product. Ensure the compliance of pharmaceutical jurisprudence i.e. acts and rules for the new products like Drugs and Cosmetics Acts and rules, DPCO Act, NDPS Act and Drugs and Magic Remedies (Objectionable Advertisement) Act, etc. Handle contract manufacturing Facilities by carrying out their periodic Facility and Product Audits and timely revert to the Manufacturing Vendors on Audit findings and closures. Identify Non-Conformances and work towards closure with RCA and CAPA . Review the quality documents received from the contract manufacturer relating to manufacturing new batches and ensure necessary regulatory and quality Compliance. Ensure Internal Quality reports reviews on a monthly basis and share the findings with the respective stakeholders and perform CAPA if required. Coordination with Contract/Public Testing Labs to ensure the products are being tested at regular intervals in order to ensure the product quality. Log and investigate market complaints with customers and manufacturing sites, for RCA and closure with appropriate CAPA. Manage / Implement corporate quality management system through SOPs, and documentation throughout contract manufacturing sites. Desired Skills and Expertise: An expert in the understanding of manufacturing stages and critical processing stages of Oral Solid Dosage Form, Oral Liquid Dosage Form & Injectables / Parenteral, and various other dosage forms . Good knowledge and assessment capabilities of manufacturing sites with respect to GMP and GLP . Experience in Auditing WHO or EU - GMP Facilities. Good understanding of Pharmacopoeia, WHO - GMP, Schedule M & ICH Guidelines Good understanding of the Drug and Cosmetic Act from regulatory and artwork Management standpoint. Good knowledge of investigation tools for RCA and CAPA. Understanding of vendor management (Product and Facility Audit) Good written and verbal communication skills Self-driven and motivated Willing to work in a fast pace, challenging environment in a Start-up Hands-on experience with Excel. Qualifications Required: Degree in pharmaceutical sciences or pharmacy. Minimum 5 years of experience in Corporate Quality Functions including experience in site auditing and compliance. Minimum 1 year of experience on the manufacturing floor.

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3 - 7 years

3 - 5 Lacs

Aurangabad

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Role & responsibilities: Asst. Officer / Officer - RM Stores Preferred candidate profile: Specify required role expertise, previous job experience, or relevant certifications. Perks and benefits: Mention available facilities and benefits the company is offering with this job.

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4 - 8 years

4 - 9 Lacs

Ahmedabad

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Role & responsibilities Reverse Engineering of Formulations: Perform reverse engineering of reference-listed drugs (RLDs) and identify composition, excipients, and active ingredients . Utilize advanced analytical techniques for component identification and quantification. Analytical Method Development & Validation: Develop and validate HPLC, UPLC, GC, LC-MS, FTIR, UV, NMR, XRD, and DSC methods for comparative studies. Characterize excipients, degradation products, and impurities in formulations. Comparative Dissolution & Physicochemical Characterization: Conduct comparative dissolution profiling with RLD as per regulatory guidelines. Study particle size, polymorphism, stability, and compatibility of drug formulations. Regulatory Compliance & Documentation: Prepare analytical reports, method validation protocols, and regulatory documents for ANDA, USFDA, MHRA, EU-GMP submissions. Ensure compliance with ICH, USP, EP, JP, and WHO guidelines. Technology Transfer & Troubleshooting: Support technology transfer for scale-up and commercialization. Assist in troubleshooting analytical challenges during formulation development . Key Skills & Competencies: Expertise in HPLC /UPLC / GC / LC-MS / FTIR / NMR/ XRD/ DSC Knowledge of polymorphism, solubility, permeability, and excipient compatibility Experience in reverse engineering & impurity profiling Strong understanding of ICH Q2 (R1), USFDA, and regulatory guidelines Hands-on experience in GMP, GLP, and stability studies Preferred candidate profile M. Pharmacy / M.Sc (Analytical Chemistry / Pharmaceutical Chemistry / Organic Chemistry) Perks and benefits As Per Company Policy

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10 - 15 years

0 - 1 Lacs

Bengaluru, Hyderabad

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• To ensure that All Operational Equipment’s should be available on time for production. • Reduce the Equipment down time to minimum 3percent. • To ensure that all activities are in a safe manner and adhere to the norms. • To ensure that all Electrical, civil and instrumental activities should be done in time. • Take care of all Utility equipment’s like chilling plants, cooling towers, VAM, Boiler, Water system, HVAC, Vacuum system, Thermic fluid system and its circulation pumps • To maintain the equipment inventory management system. • Control the monthly budget to meet committed KRA. • To develop the second level team and maintain good co-ordination among all depts. • Prepare the qualification, SOP and Change control documents to meet CGMP norms and Good Knowledge in GMP Requirements • Address the building maintenance system. • To Initiate Energy conservation activities and implement the same with proper approval. • Manpower Attrition control mechanism with motivate skills and training methods. • Prepare daily report and forward the same to site head and corporate Engineering team. • Prepare monthly reports and circulate the same to concerned teams. • Review the key result areas as committed in financial year to the top management.

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16 - 25 years

1 - 6 Lacs

Bengaluru, Hyderabad, Tamil Nadu

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*Process Management: Expertise in overseeing production processes, ensuring efficiency, compliance, and quality standards. *Production Planning & Scheduling: Ability to develop production plans that align with customer demand and business goals, optimizing resource utilization. *Leadership & Team Management: Proven track record in leading cross-functional teams, fostering collaboration, and driving high-performance cultures. *Regulatory Knowledge: Deep understanding of industry standards (GMP, FDA, EMA, ICH) and the ability to ensure compliance across all levels of production. *Quality Assurance: Strong focus on maintaining product quality, managing deviations, and implementing corrective and preventive actions (CAPA). Problem-Solving & Troubleshooting: Skilled at identifying issues in the manufacturing process, analyzing root causes, and implementing solutions quickly. *Process Optimization: Familiarity with Lean Manufacturing, Six Sigma, and other methodologies to improve operational efficiency and reduce costs. Equipment Maintenance & Management: Proficient in overseeing the upkeep, calibration, and validation of manufacturing equipment. *Safety & Compliance: In-depth knowledge of occupational health and safety standards, ensuring safe working environments.

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15 - 17 years

7 - 9 Lacs

Chennai

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JOB DESCRIPTION OF SENIOR RESEARCH SCIENTIST- QUALITY Qualification - M. Sc. /M. Phil. /Ph. D in Chemistry Experience -15 years in Quality Control/Assurance Industry - Toiletries/Cosmetics/Personal Care/Pharma Technical requisites - Hands-on experience in the following areas : 1. Ability to handle independently instrumental and chemical analytical laboratory 2. Analytical method development and validation 3. Stability study evaluation of products 4. Quality Management system and audits 5. Document and data control 6. Preparation of documents for drug/product licensing 7. Ensuring compliance to Drug & Cosmetics Act & Rules, GMP/GLP and regulations of Weights and measures act and rules 8. Product dossier preparation 9. Training Quality personnel in laboratory quality systems and management 10. Exposure in handling market complaints and root cause analysis 11. Exposure in handling Export regulations and documentation 12. Exposure in handling Halal/ISO/AYUSH License documentation

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2 - 7 years

5 - 10 Lacs

Bengaluru

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Ensures that the review of CMC documentation is completed in timely compliant manner as per Teva CORP standards and related Guidance s. Review of Method Development/Validation Protocols Reports, Stability Protocols Reports received from various Teva contracting sites, RD units, Method Development Stability Testing Centres. Review of Instrument/Equipment Qualification records. Review of BMR. Ensures that the Product Quality Reviews / Annual Product Reviews for Teva products are completed in a timely and compliant manner as per Teva s CORP Quality Management systems. PQR/APR compilation and approval must be well associated with the Teva Manufacturing Sites, Global Quality Units and Commercial affiliates to meet the targets and ensure compliance. Compilation of high quality Annual Product Reviews (APRs) / Product Quality Reviews (PQRs) for products manufactured at various manufacturing sites and retrieve data from the Quality and regulatory databases and system Liaising with third party contract manufacturers and QA/QC/Technical support personnel located globally for data collection and arranging responses. Recommend actions and professionally communicate to sites/ Quality units for continuous improvement in quality of products Receives guidance from Supervisor, Group Leader, Manager Global Quality Services, Associate Director Global Quality GBS, other Managers in Quality Strategy Shared Services, EMSO Quality affiliates, Commercial Quality EU IM, TGO sites How you ll spend your day Review of CMC Documentation Review of Method Development / Validation protocols reports. Review of Stability Study protocol, reports grids. Review of Instrument / Equipment Qualification records. Review of Batch Manufacturing Records. Liaising with contracting Teva units and QA/QC personnels located globally for arranging required documents and query responses. Escalation of issues to Supervisor, Group Leader, Manager Global Quality GBS. Contemporaneous updation of SharePoint data base Data requesting and Compilation of PQR s Compilation of high-quality Annual Product Reviews (APRs) / Product Quality Reviews (PQRs) for products manufactured at various manufacturing sites and retrieve data from the Quality and regulatory databases and systems Liaising with third party contract manufacturers and QA personnel located globally for data collection required for compilation of APRs/ PQRs. Follow up with the CMO s for the receipt of data within time. Check quotation received from CMO and initiate PR/PO for QP s approval. Once the data is received responsible for filling the PQR receipt checklist and scheduling the PQR in SharePoint. Escalation of PQR issues to Supervisor, Group Leader, Manager PQR Centre. Contemporaneous updation of SharePoint data base Quality Management Systems Initiate the process of change controls and deviations Preparation of local SOP s and its related documents. Participate in self-inspection process Performance Management Participate in continuous process improvement projects to improve efficiency of the unit Training Prepare the Training Materials for GMP training and on the job training. Imparts training on procedures as needed. Miscellaneous Support Any other tasks assigned by the management for smooth functioning of the team Your experience and qualifications 2 to 8 years of experience in QA / QC function in the pharmaceutical industry Master s Degree in Pharmacy or other natural sciences or Bachelor Degree in Pharmacy or other natural sciences Basic knowledge on worldwide cGxP regulations Good English language skills, other language skills could be helpful Good communication skills Basic knowledge of Computerised Systems. Knowledge of Systems in TEVA s IT landscape (TrackWise, SAP, LIMS, Global Insights, Glorya etc.) would be of advantage Basic understanding of manufacturing, QC and Contract manufacturing processes Engagement to drive improvements and ability to manage complexity Hands-on experience on Analytical Method development, Method Validation for API and FP of different analytical methods (e.g. Assay, impurities, dissolution etc.) Stability Studies. Hands-on experience on Review of Instrument/Equipment qualification records. Basic knowledge / hands on experience of review of BMR. Basic knowledge / hands on experience on Product Quality Reviews.

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12 - 15 years

30 - 33 Lacs

Bengaluru

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Acts as first line proxy for Associate. Dir. PQRs Global Quality GBS, India RD Quality Ensures that the APR/PQR for Teva products and review/approval of RD Documents are completed in a timely and compliant manner as per Teva s CORP Quality Management systems. PQR/APR compilation and approval must be well associated with the Teva Manufacturing Sites, Global Quality Units and Commercial affiliates to meet the targets and ensure compliance. Defines team operating standards and ensures essential CORP local procedures are followed based on knowledge of own discipline. Manages and supervises a team of 20 professional employees consisting of authors, reviewers, optional approvers and Group Leaders heading different Quality oversights. Is accountable for the performance and results of the team under his/her responsibility within the function Global Quality GBS. Creates and adapts departmental plans and priorities to address resource and operational challenges for PQR compilation, review, approval and for review, release of RD documents. Ensures that decisions are guided by CORP policies, procedures and Global Quality s business plan. Receives guidance from Associate Director Global Quality- GBS India and RD Quality, Sen. Dir. Quality Strategy and Shared Services and Global Head RD Quality, other Managers in Global Quality GBS and GBS, Global IT, EMSO Quality affiliates, Commercial Quality EU IM, TGO and RD Quality Provides technical guidance and training to employees, colleagues/related managers and/or TEVA internal customers. acts as escalation point within the interaction between the Team and external suppliers or internal stakeholders. Participates in Quality councils and delivers input for the performance of the team/teams under his/her responsibility. Is responsible for employee performance objectives in the team, conducts performance reviews and recommends pay actions. Supports modernization by use of relevant IT Tools. Ensures continuous improvement of efficiency and compliance by establishing and monitoring relevant KPIs (OPEX). How you ll spend your day Job responsibilities A) Approval of PQR s The owner of the function Approve Annual Product Reviews (APRs) / Product Quality Reviews (PQRs) which do not require approval step by any other TEVA /non-TEVA stakeholder like QPs, RPs or FvPs. Recommend actions and communicate to internal and external stakeholders for identified actions as part of the Approval process to improve quality of products (CAPA) Support and guide in escalation of PQR issues and initiate and conduct meetings / telecons if required on priority. Escalate the issues of the team to higher management for non-responsive CMO s and TEVA s internal stake holders B) Supervisor RD Quality Provide oversight for execution of activities within the RD Quality Shared Services unit including but not limited to: Review/Approval of RD documents including analytical methods, validation protocols and reports, study protocols and reports, specifications, and executed batch records. Release of Materials Provision of Inspection Readiness support Provision of support for generation and maintenance of QTA s Performance of Corporate Gap Assessments against RD site SOP s Creation/revision of RD site SOP s Review/Approval of Equipment/Instrument qualification, calibration, and maintenance documents. Review/approval of Computer Systems Validations documents Management and trending of RD Quality kpi s Preparation of presentations for RD site s Quality Council meetings Data reviews C) Quality Management Systems The owner of the function Ensures that the local quality management system is maintained in the team under his/her responsibility Ensures that the local Quality Management System is compliant with respective regulatory guidelines and TEVA s CORP QMS (Gap Assessments) Approves process of change controls and deviations Writes or approves local SOP s and its related templates. Monitors self-inspections and related CAPA of the team under his/her responsibility as per timelines and verification of compliance report. JD to be contd.. D) Performance Management Monitors and compiles the KPI scores of the team under his/her responsibility and supports the team to improve their efficiency. Participates in the customers council meetings and supports the effectiveness of the councils Participates in the Monthly Quality Council of the PQR-Center and enhances the effectiveness and efficiency of it by suitable reports/metrics and continuous improvement. Writes or evaluates the monthly reports as needed by various stakeholders. Proactively initiates and leads continuous process improvement projects to improve efficiency groups across the team. E) Training The incumbent Performs GMP training and on the job training. Imparts training on procedures as needed. Reviews the training status of the team and regularly verifies that training was performed in time and successfully. F) Miscellaneous Support The owner of the function is responsible for Maintaining Employee Central and other relevant Master Data Responsible for approval of PO s related to purchase of PQR s Review the invoicing cost involved with respect to the status. Approval of POs in SAP- for hiring and other requests like purchase orders for costs involved in updation of software Write or Review monthly report to be presented to higher management Approve various access levels for all reportees for various software on an annual basis Monitor HC justification for every approval Maintain CAPA reports and Risk Assessments on the performance of the department in cases those are requested by health authorities Support the maintenance of the IC QTA with current updates Ensures the robust handover procedure in case of exits Your experience and qualifications Bachelor s degree in pharmacy or Natural Sciences, master s degree in pharmacy or Natural Sciences More than 12 years of experience in QA / QC, RD function in the pharmaceutical industry. More than 5 years of experience in a managerial role. Well-founded knowledge on worldwide cGxP regulations. Excellent English language skills, other language skills could be helpful incl. local Indian Languages Very Good communication skills and ability to work in a matrix structure. Very good knowledge of Computerised Systems in TEVA s IT landscape (Trac-Wise, SAP, LIMS, Global Insights, Hot Dog Glorya, Veeva etc.) Good understanding of manufacturing, QC, RD and Contract manufacturing processes Engagement to drive improvements and ability to manage complexity Ability to guide a team and influence other stakeholders Ability to work as manager in a matrix organization (GBS) and act properly on conflicting interests Mobility required

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1 - 2 years

3 - 4 Lacs

Mendhar

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Job Purpose Responsible for doing village surveys, getting new customers, do CGT, house verification and income assessment, do quality sourcing, ensure collections and recoveries are done as per the group/centre meeting schedule. Maintain Healthy Customer Relationships on ground in the location Duties and Responsibilities Conduct village surveys and do prospecting in selected villages, explain BFL MFI JLG product offerings to all who attend prospecting briefing. Source New Customers in the locations allocated, form JLG groups and promote financial literacy amongst potential borrowers Collect all information needed for sourcing, data entry / upload and/or validate documents on LOS, follow entire sourcing process as defined in SOP Coordinate with BM for required approvals and Credit Ops officer at branch for disbursements as per process Plan Center Meetings of customers and notify customers in advance of the schedule, ensure 100% participation of borrowers in the center meetings. Resolve customer queries and promote top ups / cross sell as defined for the branch. Manage a portfolio of 450- 500 customers Ensure collections are done from Customers as per scheduled center meeting days, ensure 100% deposition of recovery done in defined points of disposition as per SOP. Carry out end use monitoring of loans as per the process Maintain Healthy and cordial relationship with all potential and existing borrowers, ensure 100% compliance and good conduct on all SOPs and practices as defined in the branch operating model. Create a daily report of tasks planned and executed and submit to Branch Manager. Ensure recovery disposition reconciliation is done with Credit and Ops Officer as per schedule. Ensuring critical parameters like lead to login are executed as per matrix . Maintain centre meeting discipline, follow SOPs and code of conduct Major Challenges Quality sourcing and achieving targets as defined Regular collections and maintaining customers in current bucket, regularizing and normalizing delinquent customers Compliance on all business parameters, zero audit findings on his / her sourced customer segment / portfolio

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15 - 18 years

20 - 24 Lacs

Pandua, Paonta Sahib

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Job Role : Sr. Manager Production (OSD) Job Location : Poanta Sahib Job Function : Formulations (OSD) Education : Graduate in Pharmacy (B. Pharm) Experience : 15 to 18 yrs Job Summary 1. Manufacturing and Packaging operations of Oral Solid Formulation. 2. Documentation operations of General Solid Oral Manufacturing and Packaging Department. 3. Ensure that Investigations, CAPA, Batch Records preparation completion schedule is prepared, tracked and, execution of schedule as per plan. 4. Review and production approval of documents like: I. Commercial product, stability batches, exhibit batches, characterization Batches - Master Batch manufacturing record and Master Batch Packaging record. II. Risk assessment, process validation protocol, Incident and Investigation report, CAPA Reports. III. Protocols & reports. V. Internal Quality Audit, Regulatory Quality Audit Compliance. VI. Change control, Standard Operating Procedure, and other documents including amendments. 5. Provide leadership and expertise to ensure achievement of production with respect to Quality outputs and commercial demands. 6. To ensuring that there are appropriate manufacturing and technical processes and procedures in place for the production. 7. To ensure that products are produced and stored according to the appropriate documentation in order to obtain the required quality. The production records are evaluated and signed by a designated person. 8. In coordination with Quality head monitor the factor that may affect product Quality compliance of GMP, retention of records. 9. To approve the instructions relating to production operations, including the in-process controls, and to ensure their strict implementation. 10. To check the maintenance of the department, premises and equipment. To ensure that the appropriate process validations and calibrations of control 1. equipment are performed and recorded and the reports made available. 2. To ensure that the required initial and continuing training of production personnel for SOP, cGMP, personal hygiene are carried out and adapted according to need. 3. Optimization of the resources like men, materials and machines in manufacturing and packing area. 4. Ensure efficient collaboration and co-ordination between relevant departments like Warehouse, Engineering, PPIC, Quality Control, Quality Assurance, procurement and management. Supporting Compliance of internal quality/corporate quality/regulatory audit. Planning & execution of various activities viz. Gap Analysis, enhancement, SOPs, protocols and reports etc. To perform Risk Assessment with respect to investigations, internal / regulatory observation response, market complaints and for system improvements etc. 8. To co-ordinate with FDD, PDD (R & D) /MSTG for execution of trial/exhibit /Process validation batches and trouble shooting. 9. Procurement of New Suitable Equipments required for process as per cGMP requirements. 10. Identify and implement improvements to the production process, yield. 11. To ensure protection of the product from contamination. And monitor quality standards of products. 12. Shall delegate authority to deputed deputies with satisfactory level of qualification and experience. 13. Coach and develop direct and indirect reporters through on going, example based performance feedback, annual performance reviews and provision of training and development opportunities. 14. Assure all time readiness department for regulatory agency inspections/internal audits and appropriate implementation of corrective actions regarding observations made by the agencies and internal audit teams. 15. Shall participate in Internal Quality Audit. 16. Responsible for ensuring market complaints, failures deviations are investigated and corrective and preventive actions are implemented as per set timeline. 17. Performs all work in support of our Corporate Values of pride- Humility, Integrity, passion and with accountability and diligence. Perform all work in accordance with all established regulatory and compliance and EHS requirements.

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2 - 5 years

5 - 8 Lacs

Hyderabad

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Position - Quality Operations Analyst Ideal Background / Requirements for the role: • M. Pharm/ MBA / Engineering/equivalent from a reputed institute. Skills- QMS elements from Pharmaceutical Quality Assurance Change Control is primary preferable however others can also be taken into consideration hands on exp on QMS tools AQWA, Trackwise, SAP Location- Hyderabad Duration- 1year Preferably local/ Hyderabad work mode- Hybrid 3 days in office , general shift Budget- up to 8.5 LPA Min 2-6 yr Experience in Quality Assurance, Regulatory or in the manufacturing of pharmaceutical drug substances/ products/Medical device. • GMP -knowledge, Broad IT-knowledge • Fluent in English (written and spoken) • Good communication, presentation and interpersonal skills • Experience of working closely with the global stakeholders Roles & Responsibilities: Common Accountabilities: (Applicable to all services in QOP) • Comply with internal functional requirements such as KPI reporting, ticket management tools and any other internal procedures and processes • Assist the department on any other ad hoc activities/ requests to meet the business requirements • Regularly communicate with partners and obtain feedback on services delivered • Focus on timely completion of all relevant and assigned trainings • Learn & develop understanding to generate insights through data and digital Ensure responsibility and ownership of the assigned tasks • Comply with accuracy and timeliness of deliverables Comply to the applicable Novartis operating procedures as per legal/ IT/ P&O requirements • Create and review GxP documents including SOPs, working procedures, trend reports, qualification reports and technical investigations, as and when needed • Provide active support during internal and external audits by collecting and presenting the requested process/ data and reports • Adherence to the current GxP and compliance policies of organization Perform and deliver Quality Operations services in support of product quality compliance and regulatory workflows • Hold accounts in workflow applications (such as SAP, Dragon, SUBWAY, TEDI etc.) to ensure appropriate execution of service deliverables • Generate and analyze predefined and ad-hoc reports in various applications (such as AGILE PLM, AQWA etc.) and perform follow-up actions if required • Escalate service related GxP and non-GxP issues and ensure timely investigation and compliance with local and global operating procedures • Support implementing service quality and process improvement projects, CAPA management within Quality Service Centers • Comply with all internal functional operating procedures like time tracking, KPI reporting, ticket management tools and other internal systems and processes • Assist the department on any other ad hoc administrative activities as per business requirements Regularly communicate with customers and partners to collect feedbacks on support services, report deliverable • Oversight on BOT regular performance and support the BOT validation activities as per business need • Support the Master Data Management to the required sites as required Change Control Management: • Manage different types of change control like product stewardship/Administration Stewardship/Asset Stewardship in electronic systems like TrackWise and/or Agile from Change Initiation to closure as needed • Generate and analyze predefined and ad-hoc reports in various applications and perform follow-up actions as required. Perform Regulatory assessment on Change Controls as needed. Perform deviation investigations and CAPAs as part of change management. • Artwork Second Independent Check/M05 or Artwork Second Independent Text Reviewer or Approver Interested candidates share cv : busiraju.sindhu@manpower.co.in Whats App : 7013970562

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1 - 5 years

2 - 3 Lacs

Bengaluru, Hyderabad, Mumbai (All Areas)

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Hello Candidate, Greetings of the day Hungry Bird !! We are currently hiring for Quality Shift In charge for one of our client. Location : Hyderabad Job Summary: The Quality Shift In charge is responsible for ensuring that all products meet the company's quality standards. This includes inspecting products, identifying and resolving quality problems, and documenting quality control activities. The Quality Shift In charge also provides training to team members on quality and food safety. Responsibilities:- Should maintain the company policy of personal hygiene, GMP and safety Requirements along with safeguarding the company assets as their primary responsibility. Preparation of line release documentation. Update and review and Client HACCP document. Co-ordinate with Client Block related external lab agency for timely collection of samples related to air monitoring, water, raw material and finished goods, verification of above testing reports, filing, and Invoice submission to accounts department. Ensure compliance with clients block RM, PM; FG QMS. Review and approve Client block inhouse testing report and sign document in absence of HOD. Prepare and execute the Client trial and related activity. Update Client block KPI sheet and OTUD calculation. Timely implementation of products traceability and Mock recall activities as per schedule. Timely Investigation of Client block related customer complaint, OTR & Report preparation. Timely PMP - revisions, results tracking & Follow-up of sampling. Participate in Client operation review meeting with concerned team members. Verify and ensure the compliance to customer requirements of GMP, GHK, Company Quality and Food Safety Policy. Conducting process and Internal audits providing timely communication to Inter & Intra departmental as per schedule. Participate and act as coordinator in Client sensory session in absence of lab in charge. Preparation of Client zoning plan & Pest control layout. Timely updating of Client Block related price circular & Shelf-life display sheet and take sign off from other departments. Participate in proficiency and result reporting to Client. Provide updated Client specification, testing procedure to RM/PM Chemist. Follow up of KQ plan for newly added SKU's and change of existing SKU's with clients co-man quality. Method monitoring and method verification. Operate the lab in line with the Clients GLP requirements. Authorities:- To Provide training to team members on quality and food safety and customer requirements sensory screening documentation - RM, attribute, basic & advanced. To release the SFG, PM & FG in SAP transactions. To verify and sign the testing report, LPR and act as Deputy to HOD in absence of HOD. To hold the non-complied or OOS product and stop the process and packing line in case of any deviations. To participate in all types of Trial and Sensory sessions and report generation, communication with concerned. To file all LPR, calibration, testing report, customer specification and storage in record and disposal post completion of retention period. To raise the indents as per requirements in the department and coordinate with accounts department for PO preparation. Interested candidates can share their CV to renu@hungrybird.in / 8885825360 priya@hungrybird.in / 8008832123 hr@hungrybird.in / 9701432176 Please furnish the below-mentioned details that would help us expedite the process. PLEASE MENTION THE RELEVANT POSITION IN THE SUBJECT LINE OF THE EMAIL. Example: KRISHNA, HR MANAGER, 7 YEARS, 20 DAYS NOTICE Name: Position applying for: Total experience: Notice period: Current Salary: Expected Salary: Thanks and Regards renu@hungrybird.in / 8885825360 priya@hungrybird.in / 8008832123 hr@hungrybird.in / 9701432176

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3 - 6 years

2 - 3 Lacs

Bengaluru, Hyderabad, Mumbai (All Areas)

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Hello Candidate, Greetings of the day from Hungry Bird!! We are currently hiring for Lab Incharge for our client. Location : Hyderabad. Job Summary: The Lab Incharge is responsible for overseeing the daily operations of the laboratory, ensuring compliance with safety and quality standards, and maintaining accurate records. This role involves conducting tests, managing samples, calibrating equipment, and training lab personnel. Responsibilities: Should maintain the company policy of personal hygiene, GMP and safety Requirements along with safeguarding the company assets as their primary responsibility. Conducting the checks for Clients block incoming checks for SFG / PM, FG as per customer specification. Clients block sample collection, identification, analysis and documentation. Sending courier samples to external testing lab and submission of invoice to accounts department. Train the lab helper in case of any requirements and change in existing practices. Verify and ensure the compliance in day-to-day lab operations. Carry out internal calibration of lab equipment's. Operate the lab in line with the GLP requirements. Communicate to HOD in case of any abnormality, deviations observed. Maintain the overall housekeeping of Lab, Timely disposal of samples. Monitor the retention sample and timely disposal in consultation with HOD. Track the courier samples sent. Participate in Clients customer complaint investigation. Authorities: To communicate with vendor with respect to online rejection in incoming material. To hold the incoming material with deviation in consultation with HOD. To raise the indents for lab as per requirements and coordinate with accounts department for PO preparation To maintain only update version of specification, artwork, shade card. To remove the obsolete copies of documents and discard as per SOP. To share the in-house testing report and COA with customer Prepare the COA for in house testing samples. Interested candidates can share their CV to renu@hungrybird.in / 8885825360 priya@hungrybird.in / 8008832123 hr@hungrybird.in / 9701432176 Please furnish the below-mentioned details that would help us expedite the process. PLEASE MENTION THE RELEVANT POSITION IN THE SUBJECT LINE OF THE EMAIL. Example: KRISHNA, HR MANAGER, 7 YEARS, 20 DAYS NOTICE Name: Position applying for: Total experience: Notice period: Current Salary: Expected Salary: Thanks and Regards renu@hungrybird.in / 8885825360 priya@hungrybird.in / 8008832123 hr@hungrybird.in / 9701432176

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Exploring GMP Jobs in India

The good manufacturing practice (GMP) job market in India is thriving with numerous opportunities for job seekers looking to build a career in this field. GMP professionals play a crucial role in ensuring that pharmaceutical, food, and other industries comply with quality standards and regulations to produce safe products for consumers.

Top Hiring Locations in India

  1. Mumbai
  2. Bangalore
  3. Hyderabad
  4. Delhi
  5. Pune

These cities are known for their strong presence in the pharmaceutical and manufacturing industries, making them hotspots for GMP job opportunities.

Average Salary Range

The salary range for GMP professionals in India varies based on experience and location. Entry-level positions can expect to earn around INR 3-5 lakhs per year, while experienced professionals can command salaries ranging from INR 8-15 lakhs per year.

Career Path

A typical career path in the GMP field may start as a Quality Control Officer, progress to Quality Assurance Manager, and eventually lead to roles such as Quality Head or Compliance Director. Continuous learning and certifications can further accelerate career growth in this domain.

Related Skills

In addition to expertise in GMP, professionals in this field are often expected to possess skills in regulatory compliance, quality management systems, risk assessment, and audit processes.

Interview Questions

  • What is GMP and why is it important in manufacturing? (basic)
  • Can you explain the difference between GMP and GDP (Good Distribution Practice)? (medium)
  • How do you ensure compliance with GMP regulations in a manufacturing facility? (medium)
  • What are the common challenges faced in maintaining GMP standards and how do you address them? (medium)
  • Describe a situation where you had to handle a GMP violation. How did you resolve it? (advanced)
  • How do you stay updated with the latest developments in GMP regulations? (basic)
  • What role does documentation play in GMP compliance? (basic)
  • How do you conduct risk assessments in the context of GMP? (medium)
  • Can you walk us through your experience with GMP audits? (medium)
  • How do you handle deviations from GMP standards in a production process? (advanced)
  • What steps would you take to implement GMP in a new manufacturing facility? (medium)
  • How do you ensure that all employees in a manufacturing facility are trained on GMP requirements? (basic)
  • Describe a successful GMP improvement project that you led. (advanced)
  • How do you prioritize tasks to ensure GMP compliance while meeting production deadlines? (medium)
  • What measures do you take to prevent cross-contamination in a manufacturing environment? (medium)
  • How do you communicate GMP requirements to different stakeholders within an organization? (basic)
  • Can you provide an example of a GMP non-conformance and how you addressed it? (advanced)
  • How do you handle changes in GMP regulations and incorporate them into existing processes? (medium)
  • What role does technology play in ensuring GMP compliance? (basic)
  • How do you ensure that suppliers and vendors adhere to GMP standards in the supply chain? (medium)
  • Describe a situation where you had to make a difficult decision to maintain GMP compliance. (advanced)
  • How do you conduct root cause analysis for GMP deviations? (medium)
  • What strategies do you use to create a culture of quality and compliance in an organization? (medium)
  • How do you assess the effectiveness of GMP training programs for employees? (medium)
  • Can you provide examples of key performance indicators (KPIs) that you use to measure GMP compliance? (advanced)

Closing Remark

As you explore GMP job opportunities in India, remember to showcase your expertise, experience, and readiness to adapt to the evolving regulatory landscape. By preparing thoroughly and demonstrating your commitment to quality and compliance, you can position yourself as a valuable asset in this dynamic field. Good luck with your job search!

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