1753 Gmp Jobs - Page 9

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 6000 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 70 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 To Manage the entire qualification and validation activities in the site specifically related to equipment/utility qualification, cleaning validation, process validation, packaging validation and perform the activities in compliance with the various regulatory guidelines and standards. To monitor regular activities related to quality validation and engineering as per established procedures. Job Responsibilities Review and approval of documents pertaining to equipment/utility qualification, cleaning validation, process validation, hold time studies and packaging validation. Approval of layouts, yearly & monthly schedules, to be added planners. SME for Qualifications and Validations during Regulatory audits and ensuring compliance to regulatory requirements. Assess change controls related facility, equipment, process, utility, cleaning and packaging. Review & approve of standard operating procedures. Co-ordination and implementation of training activities of team members. Responsible for review of site VMP s (Validation Master Plan) and related documents. Responsible for review and approval of process validation & cleaning validation protcolsand reports. Co-ordinate with cross functional teams in Investigations carried out at ARPL. Performs all work in support of our Corporate Values of Collaboration, Courage, Perseverance and Passion, Demonstrates strong and visible support of our values. Performs all work in accordance with all established regulatory and compliance and safety requirements. All other duties as assigned as per the expertise in the relevant subject. Job Requirements Education Minimum Bachelor of Pharmacy/ Science or any equivalent degree. Knowledge, Skills and Abilities Possess sound knowledge in Qualification and Validation of Equipment, Facility, Utilities, Process and Cleaning Maintains good Interpersonal skills and communication skills. Strives to drive projects related to Validations & Engineering effectively. Experience Minimum 12 - 15 years of experience in GMP Regulated pharmaceutical industry 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.

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 6000 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 70 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 Responsible for Stability Management Activity, Documentation and Training coordination. Initiate and evaluate various investigations and excursions as per SOP. Review of data, Documents, SOP, Specifications, Protocols and Reports wherever applicable. Responsible for all stability Management activities. Job Responsibilities Planning of stability samples to be charged. To ensure the smooth general day-to-day functioning of the Team activities. Review of Stability Protocols. Review of LIMS parameter in the stability projects for revised test profile (as applicable). Updation and authorization stability tracker entries. Review of inventory, chamber cleaning, stability reserve samples, chamber events logbooks, verification for completeness of stability samples receipt logbook etc. Review of Monthly Withdrawal Schedule. Ensuring the stability terminated samples disposition. To review various documents like Standard operating procedures, Formats, stability protocols, Specifications, Method of analysis, Analytical reports etc. for the analytical support to the Laboratories To monitor and co-ordination of Stability Management activities like set-up and withdrawal of Bio/pilot/Exhibit batches, commercial batches and other stability samples as per ICH guidelines. Responsible for LIMS related activity of stability Management (Stability Protocol Review & Approval in LIMS and samples pulling based on pulling time etc.,), Review of LIMS Data. To co-ordinate within the groups and partner companies for the initiating of stability study related to new as well as existing products. Review and co-ordination for stability related equipment qualification activity. Assessment of all supplier driven change controls, SOP related change controls with respect to impact on stability. Assessment and completion of action items for change in stability specification. Change control assessment of all manufacturing and packaging documents creation and revision. Responsible to work in coordination with Lead investigators for all stability related deviations other than laboratory deviations. Preparing and assessment of rate of change required for stability failure investigations required for GTA and ARPL. Responsible for any CAPA implementation and monitoring from stability team. Review of Monthly alarm report for all stability chambers. Review of Quarterly alarm trending report for all stability chambers. Generation & Review of Monthly stability compliance Report of laboratories. Generation & Review of Stability Summary Report for Stability Batches Review of all stability commitments for each products made by Regulatory affairs department for submission purpose. Providing data to Regulatory dept. for Annual Reports as per request. Results recording with respective stability batches in SAP Assessment of SAP Notification task for all retest batches. SAP notification assessment for re-pack/de-pack batches. Assessment and creation of Commitment for commercial stability batches as and when new product is launched and on quarterly basis. Review of the engineering M1 & M2 Notification with respective to the Stability chamber activities. Documentation control: ensuring archival / retrieval and updation of documentation as per regulatory compliance To be responsible for all activities, including cGMP/cGLP/cGXP, documentation and implementation of departmental Quality Systems. To provide, execute and impart training to colleagues with respect to procedures review and updating encourage high performance culture and a safe working environment for all employees. Job Requirements Education Minimum M.Sc / B.Pharm or any equivalent degree Knowledge, Skills and Abilities Knowledge in LIMS with respective to the Stability Managment Knowledge in the Quality Systems Handling of Stability Management activities Experience in working online modules / software Experience Minimum 7 to 14 years of experience in GMP regulated Pharmaceutical Industry 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.

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 6000 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 70 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 Responsible for effective review and approval of Laboratory investigation reports / Deviations / Corrective and preventive actions (CAPA s)/ change controls/ method transfer/ validation protocols and reports in a timely and compliant manner. Job Responsibilities Review and approval of lab investigation reports , Deviations, Corrective action and preventive actions (CAPA s) and Temporary change controls. Provide guidance on technical assessment/ investigations to team members and stake holders to ensure compliance. Review of standard operating procedures. Assessment and approval of change controls. Review and approval of instrument qualification and calibtration documents in timely manner. Review and approval of method transfer and validation protocols/ reports. Review and approval of specifications and MOA. Provide support to self inspections and audits by regulatory authorities / third parties as required. Responsible and accountable for managing subordinates and to provide all required training requirements, tools and follow procedures in accordance with applicable regulatory and other pertinent requirements. Provide training as required. Recruit, train, develop and manage effectively the ongoing performance of the direct reports, which includes but not limited to: Reviewing and updating team developing plans, ensuring that all the team members are properly trained and qualified to execute their duties. Providing coaching, feedback and recognition. Perform all work in support of our corporate values of collaboration,courage, perseverance and passion. Demonstrates strong and visible support of values. Communicate corporate vision and goals to direct reports in an effective and efficient manner. All other duties as assigned. Job Requirements Education Minimum Bachelor of Pharmacy / Science or any equivalent degree. Knowledge, Skills and Abilities Possess sound knowledge in quality management system which comprises of change controls, deviations and LIR s Hands on experience in Trackwise application, LIMS and Empower application. Maintains good interpersonal skills and communication skills. Knowledge on method transfer and validation activities. Experience Minimum 8-12 years of experience in GMP regulated pharmaceutical industry. 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.

;:" Your Responsibilities Ensure and adherence and compliance to ADM safety and Policies. Responsible for total oil packaging operations. Responsible for implementation of GMP and Food Safety Policies Planning Dispatches with sales team and Logistics Providers Follow- up of oil production with reference to the production plan as approved by the plant head Understanding Technical Specifications of different types of packaging materials and govt. norms. Ensure product quality as per customerquality standard. Ensure availability of packaging materials Ensure checking of samples in accordance to requirements of the ADM specialization and quality. Responsible for final inspection of finished products. Optimum utilization of Manpower to achieve the production target manpower development. Evaluate workers performance and ensure discipline Identify training need and provide training, as required time to time. Ensure cost reduction by reducing all kind of wastage and efficiently utilize all kind of resources. Handle Audits and Inspections. Ensure calibration of all the electrical packaging equipment. Ensure proper maintenance of records of all issuance of all issuing, receiving, materials, production, delivery, wastage, test results etc. Any other task as assigned by the Management. Your Profile Bachelor Degree in Food Technology, Packaging Specialization or other stream. Must have 5-8 years strong related experience in team leading role. Should have experience of working in a FMCG or manufacturing organisation Legal metrology laws regulations. Language Proficiency-English, Hindi. Marathi-good to have

We are seeking a diligent and meticulous Junior Executive - Laboratory Medicine to oversee the daily operations of our quality control laboratory, with a specific focus on the Microbiology department . This role is crucial in ensuring that all products consistently meet our established standards of quality, safety, and reliability. The ideal candidate will be responsible for supervising lab personnel, managing testing procedures (including microbiology samples), enforcing compliance with internal and external standards (e.g., ISO), and contributing to continuous improvement initiatives to optimize our quality processes. If you have a strong background in laboratory quality control, microbiology, and a commitment to excellence, we encourage you to apply. As a Junior Executive - Laboratory Medicine, your key responsibilities will include: 1. Quality Control & Assurance Supervise and guide the QA/QC team in product sampling, testing, and evaluation processes. Ensure all products consistently meet company and regulatory quality standards. Investigate non-conformities and initiate timely corrective and preventive actions (CAPA). Develop, implement, and maintain robust quality control procedures and essential documentation. Review and approve test results for raw materials, in-process samples, and finished goods. 2. Laboratory Operations & Microbiology Management Oversee the daily operations of the quality control laboratory, including staff scheduling, training, and performance monitoring. Specifically supervise the Microbiology department , ensuring adherence to standard protocols for processing, testing, and managing all microbiology samples. Ensure all lab equipment is properly calibrated, meticulously maintained, and functioning accurately. Develop and validate new testing methods as required to enhance efficiency and accuracy. Maintain an accurate inventory of lab supplies and ensure strict compliance with all safety standards. Prepare and maintain comprehensive SOPs (Standard Operating Procedures), detailed logs, and technical reports. 3. Compliance & Documentation Ensure full compliance with applicable industry standards and stringent regulatory requirements (e.g., ISO 9001, GMP, FDA, HACCP). Maintain accurate and complete quality records, ensuring readiness for all audits and inspections. Assist with both internal and external audits and effectively implement any required corrective actions. 4. Continuous Improvement Identify opportunities for process enhancements and actively lead quality improvement projects. Monitor key quality metrics (e.g., defect rates, test turnaround times) to drive performance. Provide essential training to production and laboratory personnel on critical quality principles and procedures.

Job Summary ( Summarize the primary purpose & key accountabilities of the job function. ) The lead Program Management, Small Molecules position is responsible for establishing and providing overall leadership in project management for small molecules technology (SMT)and Analytical technology (AT) in Chennai, as well as supporting the management of OpEx and CapEx budgets. Support Stores & Logistics for the synergy site Job Responsibilties ( Indicate the primary responsibilities critical to the job function. ) Provides leadership to Project Management team by defining clear, realistic goals; removes barriers to ensure team progress, and facilitates rapid decision-making. Facilitates resolution and appropriate escalation of conflicts within the team and with other stakeholders to ensure project success. Manage internal and external business partners to achieve common objectives. Engages, influences, and coordinates all functions involved in the development of the assigned products. Partners with other functions in the organization to ensure stakeholders requirements are addressed and met as appropriate; to provide consistent direction to cross-functional teams and to instill a spirit of collaboration throughout the organization. Establishes program goals and milestones in alignment with Pfizers (SMT & AT) overall business strategy and processes. Monitors the existing processes and may propose or implement process changes where needed. Provides the ability to foresee and recognize potential issues that impact the portfolio and works diligently to clear these barriers, resolve conflicts, or facilitate rapid resolution with the appropriate team members. When unable to resolve, raises issues to higher levels of management and follows through with the agreed upon resolution. Accountable for the portfolio which includes identifying appropriate level of resources, gaining buy-in from functional managers, setting up budgets, communicating key events and issues with recommendations and action plans. Manages effective governance meetings. Provides guidance to the Project Management team members where needed to ensure goals are being met Develop operating plan and budget (Site Budget, Capex, Project) in collaboration with Finance Work with site lead to bring strategies time to time for site to grow & deliver the planned strategies Work with leadership team to bring new governance Project management support for Chennai Analytical Technology team Budgeting (OpEx and CapEx) to SMT & AT Facility creation management through the multiple steps of build and continuous improvement and expansion project Will be responsible for project managing Industry -Academia collaboration (PFE & IITM-RP) projects CRO/CMO management to support multiple projects as needed Provide leadership to the site project team to deliver as per plan and bring visibility across functions Develop and maintain a high performing team to monitor and report multiple projects across SMT & AT Manage Day-to-day activities & any time audit readiness support for Stores and Logistics Bringing new tools to support smooth transactions Qualifications/Skills: Education - Experience - Additional Requirements ( Indicate qualifications and skills that are necessary for the performance of responsibilities including: education, relevant experience, licenses, certifications, and other job-related technical and managerial skills. ) Qualifications/Skills: A Master of Science (MSc) or Doctor of Philosophy (PhD) in a scientific or technical field related to Chemistry or Chemical Engineering. Over 15 years of experience in scientific and technical project management positions in the pharmaceutical sector, covering areas such as new product development, commercialization, and technical life cycle and supply strategy for small molecule products. Advanced project management skill sets in scoping, activity/resource analysis, financials and milestone development, with a track record of best practices applied in a commercial manufacturing environment Effective project management skills set and demonstrated a record of success in leading technical and multi-disciplinary matrix teams to successful outcomes Hands-on experience of drug regulations/regulatory processes and quality/GMP/compliance systems of the pharmaceutical industry Experience in managing a portfolio of projects, including managing the direct staff of project managers is required. Management of the governance process. Development of operating plan / budget in collaboration with Finance Continuous improvement initiatives Must-have Familiarity and experience with small molecule manufacturing technologies, unit operations, manufacturing facilities, and regulatory expectations Demonstrated track record of excellent direct and matrix leadership skills, with a passion for developing capability in others Excellent technical project / program management track record in bringing multi-disciplinary projects through to implementation / regulatory approval Active listener and inclusive partner with the ability to effectively engage and interact with multiple stakeholders Proven ability to synthesize significant volumes of complex information into clear priorities, yet comfortable operating in a dynamic environment with agility to quickly change course Proven ability to synthesize process/product-related knowledge, reflecting it in a systematic way so that it can be leveraged by customers and stakeholders Maintain the depth of technical, regulatory, and project management capability of the Technical Teams through effective talent management, resource planning and program performance monitoring Nice-to-Have PMP certification Handling Power BI tool Organizational Relationships: (Provide the primary groups or key role(s) that this role will interact with as a regular part of the job responsibilities. Include any external interactions as appropriate. ) Small Molecule Technology Analytical Technology Global Technology Engineering & Launch Pfizer Manufacturing Sites External Supply Global Supply Chain Regulatory Sciences Global EHS Procurement Pharmaceutical Sciences Small Molecule Contract Research, Development and Manufacturing Organizations Academic Institutes External consultancy group Legal Firms Work Location Assignment: Hybrid Continuous Imprv and Proj Mgmt #LI-PFE

Key Result Areas Role-specific: Active involvement in all upstream manufacturing activities. Perform error free operation by eliminating operational gaps in advance. Active trouble shooting to minimize the various risks prior to execution and during execution. Initiate and process upstream deviations /investigations and closure. Pre -execution activity: Area and equipment readiness. Issuance of raw material /consumables and issuance batch records. Upstream process execution: Batch process operation /unit operation (including CIP, SIP and preparation upstream accessories), close monitoring of batch performance and data. Follow and practice on-line documentation all the time. Follow cGMP practices during the manufacturing activity and operations associated activities with QA, QC and EAM. Attend the training session of EHS, cGMP and HRD. Ensure process equipments/instruments are in Qualified in state. Verify PM, check the log books and ensure the clean room requirements in order to get line clearance from QA for batch execution. Active coordination with inter-depts. for sample submission, closure of documentation and timely execution and contribution for the assigned tasks. Perform on-line documentation, cGMP compliance in all the manufacturing activity, and timely closure of executed documents and batch records. Ensure the Quality system is followed in day today upstream operations. Identify the gaps in the system to improve. Active involvement in all upstream manufacturing activities. Perform error free operation by eliminating operational gaps in advance. Active trouble shooting to minimize the various risks prior to execution and during execution. Initiate and process upstream deviations /investigations and closure. TECHNICAL /FUNCTIONAL SKILL: Expertise in Upstream unit operations (CHO based mammalian expression systems). Strong Hands on experience with SUB (Up to 2000 L scale) Exposure to handle of Bio-similar proteins and Mabs projects in cGMP area. Sound knowledge and awareness of GMP controls, Quality systems and regulatory aspects Experience on risk assessment tools and change management. Experience on the Equipment Qualification and commission aspects

Key Result Areas Role-specific: Active involvement in all upstream manufacturing activities. Perform error free operation by eliminating operational gaps in advance. Active trouble shooting to minimize the various risks prior to execution and during execution. Initiate and process upstream deviations /investigations and closure. Pre -execution activity: Area and equipment readiness. Issuance of raw material /consumables and issuance batch records. Upstream process execution: Batch process operation /unit operation (including CIP, SIP and preparation upstream accessories), close monitoring of batch performance and data. Follow and practice on-line documentation all the time. Follow cGMP practices during the manufacturing activity and operations associated activities with QA, QC and EAM. Attend the training session of EHS, cGMP and HRD. Ensure process equipments/instruments are in Qualified in state. Verify PM, check the log books and ensure the clean room requirements in order to get line clearance from QA for batch execution. Active coordination with inter-depts. for sample submission, closure of documentation and timely execution and contribution for the assigned tasks. Perform on-line documentation, cGMP compliance in all the manufacturing activity, and timely closure of executed documents and batch records. Ensure the Quality system is followed in day today upstream operations. Identify the gaps in the system to improve. Active involvement in all upstream manufacturing activities. Perform error free operation by eliminating operational gaps in advance. Active trouble shooting to minimize the various risks prior to execution and during execution. Initiate and process upstream deviations /investigations and closure. TECHNICAL /FUNCTIONAL SKILL: Expertise in Upstream unit operations (CHO based mammalian expression systems). Strong Hands on experience with SUB (Up to 2000 L scale) Exposure to handle of Bio-similar proteins and Mabs projects in cGMP area. Sound knowledge and awareness of GMP controls, Quality systems and regulatory aspects Experience on risk assessment tools and change management. Experience on the Equipment Qualification and commission aspects

Role & responsibilities 1.Responsible for leading initiatives of Manufacturing Excellence at respective plants to improve operational efficiency, Wastage reduction, Cost efficiency, Continuous improvement and enhance quality across plants. 2.Identifying opportunities for process improvements and implementing Lean, Six Sigma, and other methodologies. 3.Monitoring the ongoing performance of optimized processes. 4.Identifying and eliminating waste in production processes. 5.Optimizing resource utilization and reducing costs. 6.Leading and facilitating change initiatives to drive continuous improvement. 7.Promoting a culture of innovation and collaboration across functions and plant. 8.Coaching, mentoring, and developing the cross functional team on Continuous improvement. 9.To Review & Monitor daily OEE, Prepare action plan fortnightly for improvement and present it to the management. 10.To Implement and monitor the quality circles across plant for improvements. 11.Responsible for driving all OEE initiatives/Improvement projects assigned by ME Head. 12.Productivity Enhancement of Production lines through the approach of Quality Circle Project. 13.Collaborate with other plants to harmonize the practices of Manufacturing Excellence across the organization.

Oversees QC activities, staff training, SOPs, calibrations, GLP compliance, audits, records, and lab investigations (OOS/OOT) and aligns QC goals with production and ensures lab standards (candidates having approval from Raj. FDA will be preferred).

Overseeing the networks, servers, and operating systems to ensure seamless functionality, stability, and high performance across all sites, including managing legacy systems and integrating new technologies like IoT and cloud solutions. Leading the implementation of IT projects, including system upgrades, migrations, and new technology rollouts, ensuring they are completed on time, within scope, and within budget. Collaborating with senior management to develop and execute the IT strategy, identifying and recommending technology solutions to improve operational efficiency, production processes, and business growth within the manufacturing environment. Ensuring compliance with relevant industry standards and regulations (e.g., GMP and FDA guidelines in the pharmaceutical industry). Implementing and maintaining robust security measures, including firewalls, antivirus solutions, and intrusion detection systems, to protect sensitive data and systems from cyber threats, ensuring compliance with industry regulations and best practices (e.g., SOX, ISO 27001, ISO 22301). Key Skills and Attributes: Proficient in IT infrastructure, networks, operating systems (e.g., Microsoft and Linux), databases, and cloud solutions (e.g., AWS, Azure, Google Cloud). Knowledge of cybersecurity best practices, risk management, threat detection, and compliance requirements. Ability to manage, analyze, and leverage data effectively for process optimization, forecasting, and improved decision-making. Familiarity with technologies shaping manufacturing, such as Industry 4.0, Industrial IoT, AI, Machine Learning, Robotics, Automation, Digital Twins, Additive Manufacturing, and AR/VR. Practical experience in integrating Information Technology (IT) and Operational Technology (OT) systems within manufacturing environments (e.g., ERP, MES, SCADA, ICS). Network Infrastructure, ERP Systems, Operational Technology (OT), Cybersecurity, Industrial Automation & IoT, Data Analytics, Cloud Computing, Server Management. Active Directory configuration DNS/DHCP Server

Role & responsibilities: To enhance the quality system by imparting cGMP knowledge and updating regulatory requirements to the sites. To provide new regulatory guidance and technical documents to the site. To maintain a quality intelligence database and inform the concerned site about current regulatory requirements, updates and changes as and when required. To prepare corporate quality policy, standard practices, and corporate directives for system harmonization across all sites. To evaluate and ensure continual improvement of the quality management system. To verify policy implementation at the site and extend the identified gaps to the site for compliance. To review and evaluate regulatory guidelines, other company 483s, warning letters and inspection reports as per current regulatory requirements and extend identified gaps into quality intelligence portal to sites for compliance. To inform the Zydus family about new quality issues, current regulatory inspection trends, forecasts and best possible practices. To impart policy training to the site as and when required. To initiate corporate change controls for preparation and revision of quality policies. To review, verify and monitor the implementation of extended Global CAPA, Policy implementation observations and quality intelligence observations at sites. To perform any other activity assigned by HOD, as and when required. Preferred candidate profile: 2 Vacancies: one is for QA OSD background and second is for QA Injectable background. Candidate must be from pharma QA (OSD or Injectable) background. Must have Good communication skill, drafting skill and interpersonal skills. Must ready to travel to site location for inspections and audit. Must be ready to work at Ahmedabad location.

Develop, implement & maintain a robust Quality Management System (QMS) in compliance with applicable regulations (GLP, GCP, GXP, ICH guidelines) Create, review, and manage SOPs, work instructions, protocols, reports & documentation across departments Required Candidate profile 4+ years of experience in QA/QC within the pharmaceutical, biotech or drug discovery industry. Quality control certifications are preferred In depth understanding of QA/QC procedures & legal standards

The Opportunity: Responsible in preparing customer files, review batch records, and release batch records. Liaison to our customer's quality assurance groups for batch record review and release. Manage the communication between the operations/production, project management, and other quality groups. Approve all batch records prior to production to ensure that they conform to requirements of cGMP What were looking for: Education: M.Sc (Chemistry) Experience: Minimum 3-5 years of experience in Pharma Industry How you will thrive and create an impact: - Batch release procedure - Document and data control - Handling of OOS, CAPA, Incident, Change control etc. - Plant round and IPQA activity - GMP and 21 CFR activity - Data integrity policy - APQR Preparation

You will be responsible for performing chemical and instrumentation analysis on various materials including in-process, raw materials, packing materials, intermediates, and finished products. Your primary goal will be to ensure compliance with dispatch timelines as per the monthly schedule provided by PPL. Your duties will include conducting instrumentation analysis using ICP-MS and LC-MS for the mentioned materials to meet dispatch timelines. Additionally, you will be involved in analytical method developments, validations, transfers, and verifications using ICP-MS and LC-MS/MS. You will be required to prepare and review protocols, worksheets, and reports for method developments, validations, verifications, and transfers. Allotting work to chemists within the section, calibrating instruments, maintaining documentation online, and ensuring minimum stock levels for various materials and standards will also be part of your responsibilities. Monitoring and reviewing analytical data, calibration data, and qualification data, as well as ensuring instruments are calibrated and maintained in working condition, will be crucial tasks. You will also play a key role in reducing lab incidences, implementing CAPA, and maintaining safe working conditions. Collaboration with QA, Production, PPIC, Warehouse, and TSD for smooth dispatches, as well as training employees on GLP/GMP and coordinating with external laboratories, will be essential aspects of your role. Your commitment to data integrity, timely analysis and release of batches, cost control, and adherence to safety practices will contribute to the overall success of the team. This position requires a Bachelor's degree and offers an opportunity to work with Piramal Pharma Solutions (PPS), a Contract Development and Manufacturing Organization (CDMO) known for its end-to-end development and manufacturing solutions across the drug life cycle. PPAs serves customers globally and provides a wide range of services, making it a preferred partner for innovators and generic companies.,

As an Assistant Manager or Team Leader at Synnat Pharma in Visakhapatnam, you will play a crucial role in leading method development, validation, stability studies, and technology transfer activities. Your meticulous nature and extensive experience will be essential in collaborating closely with R&D, QC, and Regulatory teams to support product development and ensure compliance with global pharmaceutical standards. You should possess strong analytical expertise, leadership skills, and a dedication to regulatory compliance and continuous improvement. Your responsibilities will include developing, optimizing, and validating analytical methods such as HPLC, GC, UV-Vis, and Dissolution according to ICH and regulatory guidelines. You will be responsible for preparing and maintaining validation protocols, analytical reports, and ensuring compliance with Good Documentation Practices (GDP). Additionally, you will oversee method transfer to QC, provide training, and address any troubleshooting issues that may arise. Conducting stability studies, preparing data reports, and collaborating with cross-functional teams to support product development will also be part of your role. Furthermore, you will be expected to investigate and resolve analytical issues, including OOS, OOT, and deviations, and implement Corrective and Preventive Actions (CAPAs) as necessary. Maintaining up-to-date documentation and ensuring compliance with Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) will be integral to your responsibilities. You will also evaluate vendors and key starting materials (KSMs) and provide insights to management based on your findings. In terms of past experience, you should have a strong understanding of analytical chemistry principles and techniques, including HPLC, GC, Dissolution, and UV-Vis. Proven experience in method development, validation, and regulatory compliance is crucial for this role. Familiarity with global pharmaceutical regulations such as those from the FDA, EMA, WHO, and ICH guidelines is essential. You should also be skilled in handling regulatory submissions and documentation, possess excellent problem-solving abilities, and have experience mentoring R&D scientists. Familiarity with CAPA systems and good documentation practices will further strengthen your candidacy for this position.,

You will be responsible for the site Master Data processes to ensure accurate and timely creation and maintenance of master data in the ERP System, aligning with local and global requirements. As the Material Planner, your role involves driving the tactical purchasing process for all materials to ensure materials availability and execution plan feasibility in accordance with Site inventory policy. Your primary responsibilities will include focusing on accurate and timely preparation and maintenance of master data in the SAP ERP system, aligning with Supply chain operational activities in compliance with GxP & Regulatory requirements, internal regulations, Good Practices, and business objectives. You will be tasked with processing master Data tickets assigned as per relevant SOPs, business matrix, SLA time lines & KPIs, facilitating the setup and maintenance of Global & Local Master Data, and developing functional understanding in Supply Chain, Data Quality, and other domains. Key Role Requirements: - Minimum 6 years of experience in Master Data Operations in Supply chain Management preferred - User experience of Change Control system (e.g. SAP) and Pharmaceutical Industry experience advantageous - Understanding of working in a GxP environment and adherence to compliance policies - Proactive planning, change management anticipation, and meticulous implementation of team goals and metrics - Accountability & ownership of work with good data quality, participation in mandatory trainings, and proactive action for improvements - Initiation and Supply continuous improvement projects for operational excellence and quality enhancement - Compliance with GMP, regulatory requirements, HSE, and hands-on experience in Supply chain management and SAP ERP systems Desirable qualifications include a Graduate/Postgraduate degree in Pharmacy/Life Science/Engineering/Commerce/Economics with excellent spoken and written English skills. Novartis is committed to diversity and inclusion, aiming to build an outstanding work environment and diverse teams. If you are passionate about making a difference in patients" lives and thrive in a collaborative environment, join our Novartis Network to explore career opportunities and benefits aimed at personal and professional growth.,

As an experienced Production Chemist in the nutraceutical industry, you will play a crucial role in overseeing the manufacturing of a variety of products including tablets, capsules, proteins, and pre-workout blends. Your primary responsibilities will include leading the production process, ensuring compliance with regulatory standards such as Good Manufacturing Practices (GMP), and driving continuous process optimization. Your expertise in nutraceutical ingredients and manufacturing processes will be essential in ensuring product efficacy, stability, and regulatory compliance. You will collaborate with various teams including R&D, Quality Assurance, Purchase, and Production to enhance manufacturing efficiency and optimize processes. In addition to managing the production of nutraceutical products, you will be involved in formulating and developing new products while improving existing formulations. Monitoring quality control processes to maintain product consistency and safety will be a key aspect of your role. Troubleshooting and resolving production issues related to blending, mixing, encapsulation, and tableting will also be part of your responsibilities. To excel in this role, you should possess a Master's degree in Pharmaceutical Sciences or Food Science & Technology, along with 5-7 years of experience in the nutraceutical or Ayurveda industry. Hands-on experience with manufacturing equipment such as tablet presses, capsule filling machines, and blenders is required. A strong understanding of GMP and regulatory requirements in the nutraceutical sector, as well as excellent troubleshooting and problem-solving skills, will be crucial for success. Preferred skills for this role include experience with sports nutrition and pre-workout formulations, as well as familiarity with stability testing and shelf-life analysis. Strong leadership, communication, and team management capabilities are also essential qualities for this position. This is a full-time position with health insurance benefits, and the work schedule involves night shifts. The expected start date for this role is 20/01/2025, and the work location is in person. If you are a dedicated and experienced Production Chemist with a passion for nutraceutical manufacturing and a strong background in regulatory compliance and quality control, we encourage you to apply for this exciting opportunity to join our team.,

You will be working at Piramal Pharma Solutions in the Engineering & Projects Department located in Digwal, Hyderabad. The role involves extensive travel. Your main responsibility will be managing projects from start to finish, ensuring design, budgeting, vendor management, and execution are done efficiently and cost-effectively. It is crucial to comply with GMP, ISO 14001, OHSAS 18001, and other regulatory standards. You will oversee commissioning, validation, and operational readiness of facilities and equipment, as well as manage safety and environmental risks by implementing robust SHE practices. Continuous improvement through risk assessments, CAPA, and comprehensive training for teams and contractors is also part of your role. You will report directly to the Site Head and oversee a team of 6-8 individuals. The ideal candidate should have at least 15 years of experience in Manufacturing, GMP, Safety, and resolving technical customer queries. Good communication skills are essential. Competencies required for this role include QMS handling, understanding changing regulatory requirements, confidence in facing audits, team management, quality investigations, analytical knowledge, collaborating with CFTs, and being the SPOC for CDMO projects. Your key responsibilities will include identifying, evaluating, and implementing projects on time and within budget, designing facilities, identifying vendors and contractors, inspecting equipment and project materials, issuing specifications and drawings, commissioning projects, validating facilities, ensuring compliance with ISO14001:2004 and OHSAS 18001:1999, identifying risks and hazards, developing objectives, targets, and programs under EMS & OHSMS, monitoring operational controls, conducting root cause analysis, ensuring continual improvement in OHS & EMS Management Systems, identifying SHE training needs, and ensuring SHE requirements related to contracted services and service providers are met. The ideal candidate should hold a B-tech degree (any stream). Piramal Pharma Solutions is a Contract Development and Manufacturing Organization (CDMO) providing end-to-end development and manufacturing solutions across the drug life cycle. The organization values inclusive growth, ethical practices, and equal employment opportunity based on merit. If you are looking for a challenging role in a dynamic environment, this opportunity at Piramal Pharma Solutions could be the right fit for you.,

Job Description: As a QA Manager at Sohan Healthcare Private Limited in Daund, you will play a crucial role in overseeing quality assurance processes to ensure compliance with regulatory requirements and maintain the highest standards of quality. Your responsibilities will include conducting internal audits, managing quality control activities, and implementing quality improvement initiatives. Your expertise in Quality Assurance, Quality Control, and Regulatory Compliance will be instrumental in ensuring the smooth functioning of the quality assurance processes. Your strong analytical and problem-solving skills will be put to use to identify areas for improvement and implement necessary changes. Attention to detail and accuracy are essential qualities that you will bring to the role, ensuring that quality assurance processes are executed effectively. Your excellent communication and interpersonal skills will enable you to collaborate effectively with cross-functional teams and stakeholders. A Bachelor's or Master's degree in Pharmacy, Chemistry, or a related field is required for this role, along with experience in conducting internal audits and implementing quality improvement initiatives. Knowledge of GMP, GLP, and other relevant quality standards is essential. Certification in Quality Management or Quality Assurance would be a plus. This is a full-time on-site role that offers the opportunity to work in a dynamic environment and contribute to the success of Sohan Healthcare Private Limited.,

Responsible for day-to-day activities of Quality Control, prepare and maintain documentation as per cGMP norms. Working Experience on HPLC is must Coordinate with other depart for smooth running of plant Capable of handling external Audits Required Candidate profile Min Exp 2 to 10 years in Quality department of a reputed pharmaceutical Company Knowledge of working in GMP Co. MS Office (MS Word & MS Excel) / ERP software. and good time management skills Perks and benefits Performance linked incentive & annual bonus extra

Responsible for day-to-day activities of Quality assurance, prepare and maintain documentation, BMR, BPR, SOPs as per cGMP norms. Line clearance, IPQA Coordinate with other depart for smooth running of plant Capable of handling external Audits Required Candidate profile Min Exp 2 to 10 years in Quality department of a reputed pharmaceutical Company Knowledge of working in GMP Co. MS Office (MS Word & MS Excel) / ERP software. and good time management skills Perks and benefits Performance linked incentive & annual bonus extra

Responsible for day-to-day activities of Pharma manufacturing , prepare documentation as per cGMP norms. Working Experience on External preparations Coordinate with other depart for smooth running of plant Capable of handling external Audits Required Candidate profile Min Exp 2 to 10 years in Quality department of a reputed pharmaceutical Company Knowledge of working in GMP Co. MS Office (MS Word & MS Excel) / ERP software. and good time management skills Perks and benefits Performance linked incentive & annual bonus extra

We are looking for a highly motivated and skilled Commi 3 (Entry-Level Cook) to join our team at Bulls and Bears Bistro. The ideal candidate will have excellent culinary skills and be able to work well under pressure in a fast-paced environment. As a Commi 3, you will play a key role in ensuring the quality and consistency of our dishes. Roles and Responsibility Assist the Chef de Partie in planning and preparing menus for special events and functions. Maintain high standards of food quality, presentation, and safety. Collaborate with other kitchen staff to ensure efficient food preparation and service. Develop new recipes and menu ideas to enhance the dining experience. Participate in inventory management and ordering supplies. Ensure compliance with health and safety regulations and company policies. Job Requirements Proven experience as a cook or commis in a professional kitchen environment. Strong knowledge of food preparation techniques, ingredients, and cooking methods. Ability to work well under pressure and manage multiple tasks simultaneously. Excellent communication and teamwork skills. Familiarity with kitchen equipment and appliances. Commitment to delivering high-quality food products and exceptional customer service.

Role & responsibilities Review and approve Finished Goods and corresponding Certificates of Analysis (COA). Maintain detailed records of received samples in an organized manner. Ensure proper allocation and storage of approved COAS in the shared drive. Verify and confirm drug product permissions as per regulatory requirements. Oversee the finalization of packing materials in coordination with relevant departments. Conduct audits of new vendors, ensuring compliance with quality standards. Ensure proper implementation of Corrective and Preventive Actions (CAPA) for any deviations or complaints. Visit manufacturing sites to address and investigate market complaints effectively. Coordinate with manufacturing partners for handling market and sample-related complaints. Perform joint analysis of complaint samples in collaboration with manufacturers to identify root causes. Maintain strict adherence to Good Documentation Practices (GDP). Possess sound knowledge of Schedule M, USFDA, MHRA and ensure compliance in relevant activities. Sound knowledge of IPQA (In-Process Quality Assurance) activities across different dosage forms (e.g., tablets, capsules, syrups, ointments, etc.) Sound knowledge of different types of SOPS (Standard Operating Procedures), including preparation, review, implementation, and compliance monitoring. Basic understanding of QMS (Quality Management System), including its elements and relevance in pharmaceutical operations.