1769 Gmp Jobs - Page 38

The Senior Executive - QA (Engineering Assurance) will be responsible for executing and reviewing qualification lifecycle documents for GMP equipment, utilities, and facilities. The role includes oversight of URS, DQ, IQ, OQ, and PQ protocols, engineering change controls, risk assessments (FMEA), and periodic requalification activities. This position works closely with Engineering, Validation, Projects, and cross-functional QA teams to ensure timely qualification and regulatory readiness. Key Responsibilities: QA review and approval of qualification protocols and reports (URS, DQ, IQ, OQ, PQ) Oversight on facility, utility, and equipment qualification activities QA support for engineering change controls and deviation handling Risk assessment and mitigation using tools like FMEA and HAZOP Periodic review and requalification planning Participation in internal/external audits and regulatory inspections Ensuring data integrity and documentation compliance across qualification records B. Tech / M. Tech / B. Pharm / M. Pharm / M. Sc. with specialization in Engineering, Life Sciences, or related field 5-8 years of relevant experience in QA Engineering or Qualification/Validation domain Strong knowledge of GMP regulations (USFDA, MHRA, EU) and qualification standards (ISPE, WHO, ICH Q9, Q10) Hands-on experience in equipment/facility qualification, HVAC, water systems, and cleanroom validations Excellent documentation review, risk assessment, and communication skills

Business: PPL Digwal Department: PTS Location: Digwal Job Overview: To perform AR&D actives as per GMP & Safety Travel Requirements: NA Reporting Structure: Reports to Research Scientist - AR&D (Service) Key Stakeholders: Internal: QC, QA, SCM & Safety External: NA Experience: 4-8 Year Experience in manufacturing (API) as per Pharma Manufacturing GMP requirements. Responsibilities for Internal Candidates Key Roles & Responsibilities 1. Capable to handle independent projects 2. Analytical testing support to PDG synthetic group. 3. Coordinate with QA regarding method transfer, CCF and investigation reports. 4. Experience of handling of HPLC, GC, Potentiometer, Polarimeter instruments. 5. API Stability knowledge. 6. Capable to handle analytical method development, Implementation, Validation as per requirement. 7. Should have experience of Analytical method transfer to QC. 8. Experience of making documents like method transfer protocol & report, method validation protocol & report, method development report, specification, standard test procedure etc. 9. Should aware about GLP practices and 21 CFR part-11. 10. Keep the work area clean and the laboratory under controlled temperature. 11. Calibrate the instruments according to the master calibration schedule and follow GLP and SOPs. 12. Understand the safety and environmental aspect. 13. Maintain the reagents and standardize the volumetric solutions as per schedule. 14. Maintain the laboratory journals and instrument log books online. 15. Ensure compliance to Hazardous waste and chemical management. Qualification : M. Sc (Analytical Chemistry), (Chemistry) & (Organic Chemistry)

Role & responsibilities The position is responsible for Moisture and Thiomersal estimation and ensuring GMP practices Physical observation of vaccines and diluents Formulation Verification Record maintenance Maintenance of Live and Inactivated FG samples and register Maintenance of Pullet ND samples at R&D in coordination with production Moisture estimation of Live vaccines, stability & record keeping and R&D testing To Fill records & BTR Regarding Moisture Determination RM - pH, viscosity, density, specific gravity, refractive index, LOD, water Egg sampling and record maintenance Maintenance of retain samples of RM Preferred candidate profile Should have technical knowledge in GMP, GLP, ISO, IS, IP, BP guidelines, MS office Good in communication, inter-personal relationships Job Location: Kadi,Gujarat ( Bus facility available from Ahmedbad,Kalol & Kadi)

Supervise day-to-day operations of the external preparation manufacturing section. Ensure proper execution of batch manufacturing processes as per Batch Manufacturing Records (BMRs) and Standard Operating Procedures (SOPs). Coordinate with Quality Assurance (QA), Quality Control (QC), Warehouse, and Maintenance for smooth operations. Monitor equipment calibration, cleaning, and maintenance to ensure readiness for production. Ensure proper line clearance, area cleaning, and equipment readiness before starting manufacturing operations. Review and maintain manufacturing documentation, including BMRs, logbooks, and deviation reports. Handle in-process checks and ensure process parameters are maintained within specified limits. Train and guide operators and junior staff in GMP practices and SOP adherence. Investigate deviations and support in root cause analysis and implementation of CAPA. Ensure compliance with EHS (Environment, Health, and Safety) standards within the manufacturing area.

Stock Reconciliation, Stores Management, MHE Safety. Check vendor document against Purchase Orders. Safe precise dispensing of Raw Materials as per requisition. 3-5 years in Pharma & GMP background.

The NPI Quotation Engineer is responsible for working in close collaboration with Engineering, Commercial/Sales, Sourcing, and Production to prepare detailed and accurate comprehensive cost estimates and quotations for parts and/or assemblies identified as potential new opportunities for Flexan. Additionally, the NPI Quotation Engineer may support other NPI (New Product Introduction) workstreams including the development, creation, and or editing ofoperational, instructional, maintenance, inspection, test procedures and other documentation in support of the development and manufacture of medical devices. Responsibilities Work closely with Engineering, Commercial/Sales, Sourcing, and Production to develop comprehensive cost estimates and quotations for medical device manufacturing projects, considering location, materials, labor, overhead, and any additional costs. Work closely with engineering, production, and sales teams to understand project feasibility and ensure alignment with manufacturing capabilities. Maintain accurate records of quotations, project specifications, and client communications for future reference and auditing purposes. Ensure that all quotations comply with relevant medical device regulations and quality standards. Contribute to the development and refinement of quoting processes, tools, and templates to enhance efficiency and accuracy. Develop and update process documentation including assembly procedures, test procedures, BOMs, process flows, and process FMEAs. Produce products that conform to the company documentation and Quality Management System (QMS) standards. Recommend formats responsive to technical, operational, quality, and customer requirements. Support and implement company goals and objectives, policies and procedures, Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), FDA QSR and ISO regulations. Demonstrate all of Ingersoll Rand s corporate values. Other duties as assigned by the Director of Engineering Mandatory Skills Exceptional analytical skills with the ability to interpret technical specifications and cost data. Excellent verbal and written communication skills; ability to present complex information clearly and persuasively Must meet internal deadlines and customer due dates Must be detail oriented, focused, and committed to delivering produce accurate and high quality work Must have advanced skills in Microsoft Word, Excel, PowerPoint. Proficient in CAD software including SolidWorks Desired skills: 3+ years experience in quotation or estimating role, or manufacturing engineering experience Experience with manufacturing medical devices and associated regulatory requirements Strong understanding of manufacturing processes and material used in medical device production. Experience with product qualification and process validation activities Basic Qualifications Bachelor of science in Engineering, Manufacturing, or related technical field 3+ years experience in manufacturing engineering or a related field Must be motivated and creative, work well under pressure and operate effectively in a fast paced team environment. What we Offer We are all owners of the company! Stock options(Employee Ownership Program)that align your interests with the companys success. Yearly performance-based bonus, rewarding your hard work and dedication. Leave Encashments Maternity/Paternity Leaves Employee Health covered under Medical, Group Term Life & Accident Insurance Employee Assistance Program Employee development with LinkedIn Learning Employee recognition via Awardco Collaborative, multicultural work environment with a team of dedicated professionals, fostering innovation and teamwork.

Job Title: CSV Analyst (Computer system validation) Location: Hyderabad Exp level: 7-10 Years Work mode : Work from Office Shift Timings: UK Shift Primary Skill: CSV (Computer system validation) Secondary Skill: Pharma IT Quality

Monitor compliance with GLP, GMP or other applicable standards. Maintain and update SOPs (Standard Operating Procedures). Review laboratory notebooks, worksheets, and analytical reports. Assist in internal and external audits. Ensure accurate documentation of QA activities and laboratory testing. Review COAs (Certificates of Analysis) and batch records. Manage deviation reports, CAPAs, and change control processes. Assist in the qualification/validation of equipment, methods, and software. Ensure timely calibration and maintenance of lab instruments.

The Sr. Manager FS IN Ops serves as a pivotal leadership position within Amazon Indias Operations compliance organization, spearheading food safety compliance and regulatory programs for India Operations network comprising Fulfillment Centres, Amazon Fresh sites, Sub-same day delivery sites, Quick Commerce sites, Collection Centre sites, Dry/ Wet Hubs, etc. This role drives strategic compliance decisions that directly impact business growth, customer trust, and regulatory adherence across this complex network of sites (1p and 3p both). The role will oversee end to end processes from inbound to outbound operations. With oversight of a strong gross margin sales portfolio comprising diverse food products across multiple categories, this position demands a unique blend of technical expertise, strategic thinking, and influential leadership to navigate evolving regulatory landscapes while maintaining Amazons high standards for food safety. The role serves as the primary authority for food safety compliance, interfacing regularly with senior leadership while building robust quality management systems that protect both customer experience and business interests. In next 1-2 years, the role will be responsible for creating/ setting up scalable and robust compliance and quality improvement mechanisms and solutions which support Amazon s Operations network s complaint expansion. The role will create strategic and tactical planning for the India Ops compliance charter and will effectively write business review documents, collaborating and influencing IN Ops, Product, Technology, Legal, and Business partners. Other than holistically working on operations compliance, you will also own some thematic compliance for IN, owning legislation translation, policy creation and maintenance, and strategic improvements. Your success will be measured not just in compliance metrics, but in your ability to build sustainable systems that support Amazons continued growth while maintaining our commitment to product quality and safety. This role will report to the Head of Food Safety India. You will lead Amazon India Ops food safety initiatives. You will develop/ execute or exercise oversight on food safety management strategies that protect customers and business interests. This includes food safety/ legal/ statutory policy definition, update, efficacy check oversights for ensuring food safety throughout the IN Ops network. You will ensure Amazons food safety programs meet current and future regulatory requirements. Where needed, you develop food safety protocols, implement risk management solutions. You leverage in-depth knowledge of food safety regulations and standards, including HACCP and GMP, to monitor activities throughout food chain for upkeep of Food safety standards. Your key focus areas include: leveraging customer feedback and regulatory contacts to identify actionable insights to improve operational compliance. You will oversee metrics and mechanisms to manage a) food safety investigations, b) regulatory contacts and proactive regulatory engagement, c) site audits and compliance improvement versus defined standards, d) status of foundational compliances, including ( but not limited to) expiry, storage, temperature, pest control, licensing compliances, e) training (e.g., FOSTAC or defect specific) and on-site visuals to enhance operational compliance. You observe the mechanisms/ metrics and track trends to identify shifts in compliance performance, work with site (or relevant) teams to ensure availability of a detailed time-bound path-to-green plan against observations, and escalate effectively in case of observed deviations vs plan. You will work with site teams, leverage written and verbal communication to lead compliance discussions with cross functional teams, including Operations, Business/ Category, Legal, Product, and Technology. You create strategic partnership with stakeholders (Operations, Business, Legal, Tech) to eliminate risks, ensure compliance, and communicate safety metrics across stakeholders. You liaise with technology and product partners to ensure automation of compliance (or other) processes both implementation of controls and Andons to flag non-compliances, based on feasibility, optimize documentation systems and reduce over processing of information, and efficiently track input/output metrics. You will develop and maintain quality metrics, create reporting systems (automated), and analyze customer/ regulatory feedback, using data to identify trends and guide quality initiatives. Your focus will be on developing efficient, scalable quality management processes that efficiently adapt to or scale with business growth. You collaborate with food industry stakeholders to provide guidance on best practices for food safety and quality assurance. You act as the primary point of contact for managing regulatory interactions, ensuring timely and accurate reporting and compliance. You will connect quality and compliance requirements with business objectives, working with stakeholders. This includes regular engagement with senior leadership on compliance, regulatory matters. You will guide decisions affecting operations and strategy, requiring both technical expertise and strong communication skills. You will support network expansion while maintaining quality and compliance adherence standards. About the team At Amazon, we strive to be the most customer-centric company on Earth. Our team comprises exceptionally talented, bright, and driven individuals. Regional Operations Compliance ensures that products sold through our supply chain and on our websites are safe and compliant, and that our fulfilment network is secure. ROC is accountable for executing global and regional-specific compliance needs, focusing on protecting our customers, associates, and business from potentially harmful products or those requiring specific actions to ensure compliance with local regulations. We achieve this by implementing supplier-facing controls and advice, ensuring proper product storage and distribution, and enabling specialist high-risk and cross-border trade. Our approach combines industry-leading subject matter expertise with technologies to help us scale effectively. Bachelors or equivalent/ higher degree in Food Science/ Technology or related field 10+ years of experience in food safety management across diverse operations network (1p vs 3p, Quick Commerce, and other specialty fulfillment) 5+ years of experience for food safety management across multiple food categories 3+ years of experience in regulatory contact management and proactive regulatory engagement Project Management Professional (PMP) or equivalent certification Experience leveraging technology and implementing lean principles / Six Sigma methodologies to drive process improvements or equivalent Professional auditing qualification (lead auditor/ equivalentFSSC ver 6/ others) Experience of working in technology rich e-commerce/ quick-commerce industry

Division Department Sub Department 1 Job Purpose Monitor and execute the packing activities in a shift by maintaining cGMP and safety norms to achieve production targets Key Accountabilities (1/6) Execute shift packing activity by managing available resources and reduces micro stoppage of machine to achieve shift target Utilise shift resources optimally to get desired production output Regulate usage of consumables in the production process at optimum level to save cost Key Accountabilities (2/6) Review documentation related to packing activity and monitor standard packing parameters as per BPR to meet regulatory requirement Review and monitor critical in-process parameters like NFD, camera challenge, RH temperature etc. Review and perform all operations as per GMP and safety norms by reviewing all processes and documents for compliance Maintain system integrity by updating online documentation Perform qualification and calibration of equipment as per schedule and update output of all activities in the system Key Accountabilities (3/6) Prepare manufacturing records and update online documentation to meet production and cGMP requirement Maintain online documentation and timely entries in BPR and supporting documents by operating SAP and CipDox Prepare new documents and update existing documents as per GMP requirement Key Accountabilities (4/6) Monitor adherence to safety guidelines in the block during a shift for packing activities to create safe working environment Monitor safety systems and ensure procedures are followed in shift and near-miss cases are reported to HSE timely Ensure availability and usage of PPEs in the shift by coordinating with HSE department Ensure compliances to safety training targets by monthly reconciling attendance records Key Accountabilities (5/6) Provide training to staff & workmen for packing activity by regular interactions with them to get quality product Provide training to staff and daily workers for packing activities and safety procedures Conduct training related to equipment handling, cGMP, documentation and unit operations Key Accountabilities (6/6) Provide new ideas and simplify processes to reduce process cycle time and achieve new targets Provide new ideas during idea sessions for better productivity with minimum cost Identify the complexities and suggest process simplification areas to achieve new target with optimum utilization of resources Reduce and simplify documentation for better accuracy and to meet ALCOA (Attributable Legible Contemporaneous Original Accurate) Major Challenges Meeting shift target due to unavailability of adequate resources. Overcome by efficient work load distribution Maintaining cGMP requirements during system downtime. Overcome by coordinating with engineering and technical support team Key Interactions (1/2) Quality assurance and control for batches release as per packing plan (Daily) Engineering for preventive maintenance and help in modification (as per need) Safety for awareness training and near miss issue (Daily) Store for daily dispensing plan and availability of packing materials (Daily basis) Key Interactions (2/2) Maintenance contractor for any machine repairs (Need Based) Dimensions (1/2) Direct Reports : 3 Achieve average volume of 200 mn (FY2015-16) Average number of BPR s handled : 200 Average number of batches in packing : 200 Average number of sales order dispatched : 80 Achieve internal OTIF more than 90% Achieve Zero reportable accidents/ incidences during packing activities Achieve 0% errors in online documentation Meet 100% compliance to SOP and Safety regulation Dimensions (2/2) Key Decisions (1/2) Resources allocation and work distribution for each shift Key Decisions (2/2) Up-gradation in facility and documents to Section Head - Packing Modification in equipment to Section Head - Packing Deviation and implementation of CAPAs Section Head - Packing Education Qualification B. Pharm. / B. Sc. (Chemistry) Relevant Work Experience 1-5 years of experience in packing with knowledge of handling of QMS activity, qualification and other related documents

Division Department Sub Department 1 Job Purpose Review the compliance level of site for deficiency response, prepare master validation protocol and report as per company quality policy and applicable regulatory guidelines Key Accountabilities (1/6) Collate, review and provide required work plans on received deficiencies to HO in order to respond to regulatory authorities in a timely manner Collect data from all SPOCs with respect to received work plan for review Escalate any delays in receiving response from unit with respect to work plan Review of collected data for work plan fulfilment Send data to HO for compilation of deficiency response Take follow up with HO to receive updated dossier for product updates Review Master Validation protocol and report for timely execution of validation batches and timely submission of documents in order to response for deficiencies Review master validation protocol and report within timeline Check major observation in other units documents also for improvement of validation documents at site Synchronize all units Validation documents for improvement of all units Key Accountabilities (2/6) Review annual product quality review report at units for completeness and data correctness to ensure compliance to cGMP requirements and audit readiness Collect APQR timely with units for review Review data with supporting documents for data authentication Check major observation with other units for improvement of documents at site Review, upkeep and issue regulated market technical agreements at site for execution of batches as per customer requirement Review and compile received technical agreements for comments Provide guidance for execution of batches and handling events as per customer requirement Provide training in department to improve awareness in audit and compliance with licencing department Take follow up with HO for providing fresh TA and pending TAs for products Key Accountabilities (3/6) Receive and distribute approval certificate, dossiers (TDP & RAP) and development report at unit for execution of new products smoothly Receive and check approval certificate, dossiers (TDP & RAP) and development report for distribution at site Update site on receipt of documents for handling execution of customer or market specific batches Coordinate with auditors and site teams for regulatory and customer inspection/ audit at site to meet regulatory expectation and acquire GMP approvals Prepare final draft of compliance to audit observation and check whether it is in line with cGMP requirement to avoid regulatory action and continual improvements Inspect audit prerequisites to support and prepare for external audits Coordinate with Units for preliminary draft response and prepare final draft within timeline Follow up for closure of compliance commitments Provide adequate, errorless and timely compliance to CQA Monitor implementation of CAPA derived in compliance by assessing current regulatory requirements and inspecting its effectiveness review Prepare and submit EPA annual production application for getting the establishment registration of unit V Key Accountabilities (4/6) Collect, compile and review raw data and finalise the same for timely submission of MHRA, UK interim update document to corporate as per agency requirement by tracking interim updates at a site level, for risk based inspection planning Coordinate with units for all the raw data, its review and finalization before submission to corporate Prepare pre-inspection compliance report after announcement of MHRA audit Drive continuous improvement initiatives in CQA to facilitate adherence to cGMP Review warning letters received by competitors, analyse the current scenario to ascertain gap and prepare an action plan to prevent such an occurrence at site Review audit observations received by other Cipla sites, analyse the current scenario to ascertain gap and prepare an action plan to prevent such an occurrence at site Participate in internal team for conducting self-inspection, report preparation, submission and compliance review, to evaluate adherence to cGMP Prepare and update procedures in line with current GMP requirements Key Accountabilities (5/6) Execute on time and errorless submissions by reviewing product license, all certificates for product registration and tender , staff approvals and other applications to adhere to legal requirements Collect, review and finalize applications for: Additional Product COPP Test License Renewal of drugs manufacturing license and WHO GMP certificate All certificates for product registration and tender Alcohol Quota FDA Staff Approval Site Layout Approval Submit and process above application to FDA (district, state, CDSCO) for time bound receipt of approval Communicate with FDA to resolve queries and follow ups to monitor status of application Review, maintain and distribute approved certificates to concerned stakeholders at site Track the consumption of alcohol quota allotted by state FDA under subsidized scheme as per the plan to manage optimum level of alcohol availability for smooth functioning of site Track the status of FDA approved staff at site to adhere to Drug and Cosmetic Act Track the status of quantity specific product license to monitor dispatch of such products and renewal of license in compliance to DCGI NOC condition Key Accountabilities (6/6) Support in CDSCO and state FDA inspection to be GMP compliant and getting product licence, FDA stall approvals by ensuring cross functional interaction Inspect audit prerequisites to support and prepare for CDSCO and state FDA audits Coordinate with Units for preliminary draft response and prepare final draft within timeline Follow up for closure of compliance commitments Provide adequate, errorless and timely compliance to CQA Monitor implementation of CAPA derived in compliance by assessing current regulatory requirements and inspecting its effectiveness review Major Challenges Delay in receiving data for allotted work plans from units may impact whole process of deficiency response hence to overcome this situation we are in continue follow up with units for timely response Major observation handling in validation documents impact on registration batch execution, leading to delay in filing of product hence to overcome this situation we share and resolve each observation with units timely with resolving strategy Lack of detailed compliance with appropriate root cause from user department. Regular discussion and trainings is provided to unit Liaising with Government officials for availability and timely approvals of applications Key Interactions (1/2) SPOCs of process validation at site for timely review of master validation protocol and reports at the time document received for review (once or twice a month) SPOCs of APQR at site for timely review of APQR (monthly) SPOCs of RA at site for timely receiving of work plan response of deficiencies on (weekly) Unit QA heads in reference to audit readiness and preliminary draft response (need basis) CQA and A&C team for final draft response review (need basis) Key Interactions (2/2) FDA for processing and approval of application (need basis) Dimensions (1/2) Zero overdue compliance of deficiencies. 100% adherence to provided timelines for review of documents timely. Track and support in Top 07 projects. Timely and errorless review of APQR at site. Review should not exceeding 15 days from schedule. Ensure quality score minimum of 90% for each month. Timely and errorless preparation of tech transfer summary for site. Data submission to corporate should not go beyond 5th of every month Average 30 audits/ year 100% adherence to timeline of compliance for various regulatory and customer audits. No disruption is supply chain because of GMP approvals, product deficiency and product license For FDA: Approximately 150 additional product license 36 test license 40 certificates 290 COPP 5 staff approvals Dimensions (2/2) Key Decisions (1/2) Review observation provided for correctness and improvement of master validation protocol and report documents (To Unit QA) List of pending technical agreements with requirement of fresh TA to HO for regular execution of customer products. Review observation provided for correctness and improvement of APQRs and FDA product license applications at site (To unit QA) Recommend to update correct data provided for deficiency response (To HO) Process of identifying root cause for the observation in various inspection and audit (to CFT) Key Decisions (2/2) Education Qualification B. Pharma/ M.Sc. with minimum three/ four year of experience in quality assurance department Licensing and registration (0-2 years) Relevant Work Experience Sound knowledge of cGMPs and regulatory guidelines and basic knowledge of computer system

Division Department Sub Department 1 Job Purpose Perform sampling, execute and document the analysis of raw materials, packing materials, products assigned for testing and complete all the stability studies in order to ensure its compliance to the laid down quality parameters and predefined specifications / standards and meet SRB targets Key Accountabilities (1/6) Analyse the assigned samples and chromatographic tests for analysis by using the suitable valid procedure and calibrated instruments to ensure the compliance to the set specification / standards Perform analysis for release of RM, PM, FP & water analysis and process/cleaning validation as per commitment dates Perform analysis for stability samples without any errors as per schedule Check the results of the tests performed, evaluate them against the specifications Review the TDS printed through LIMS for its completion before release Key Accountabilities (2/6) Perform all activities as per current standard procedures by referring to all approved procedures/specifications to ensure compliance to GLP and safety norms Gather all the samples for analysis by checking the consignment for sampling Gather the essentials like standards, glassware, solvents to perform the analysis as per specification Operate the instruments and perform routine/stability as per SOP and safety norms Key Accountabilities (3/6) Document all activities performed as per valid procedure online by using standard/approved formats or templates to ensure that all entries done are correct, accurate and authentic Maintain system integrity by updating documentations and deviations on CipDox while performing operations Maintain all the online documentation and timely entries and supporting documents Prepare new documents and update existing documents as per GMP requirement Key Accountabilities (4/6) Maintain and upkeep the laboratory working area by disposing off all analysed solutions and samples after review as per valid disposal procedures to ensure compliance to GLP Maintain equipment, facility and block premises as per SOP Perform validation, qualification and calibration as per schedule and update output of all activities in the systems Key Accountabilities (5/6) Provide suggestions and ideas by exploring new possibilities to achieve cost saving and work simplification Conduct operational studies to find improvement areas and implement new development projects Strive for continuous automation of processes through implementation of new processes Key Accountabilities (6/6) Major Challenges Delay in performing analysis or re-planning due to frequent changes in production plans. Overcome by conducting performance dialogues and handshakes meetings identifying priorities Delay in performing laboratory activity due to instrument breakdown. Overcome by ensuring timely availability of parts and engineers Delay in releasing the batches due to non-availability of standards, glassware, chemicals. Overcome by coordinating with CFTs and escalations Key Interactions (1/2) Unit Planning for daily release of RM,PM and FP (Daily) Site QC (Non-Routine) for essentials of analysis (Daily) CDC for specification changes implementation (Need Basis) Unit QA for non-conformances (Need Basis) Stores for inventory (Daily) Key Interactions (2/2) Service Engineer to resolve instrument related issues, breakdown (Need Basis) Dimensions (1/2) Number of FP batches released: 3-4 Number of RM analysis conducted : 3-4 Number of studies conducted for Stability samples : 10 Non-conformance OOS/OOT to be closed within 7 working days Non-conformance rate should be below 1.5% Dimensions (2/2) Key Decisions (1/2) Suggestions for improvement of QC productivity to Team Leader (Routine/Stability) Procurement of required instruments and glassware standards to Team Leader (Routine/Stability) Key Decisions (2/2) Education Qualification B. Sc. (Chemistry) or B. Pharm. Relevant Work Experience 0-3 years of experience in quality control function of a pharmaceutical organisation

Job Description Version. no.: The Job Responsibilities of the position holder are : Responsible for performing the analytical activities as per Analytical competency matrix (Format No.BDI-QCSG004F23) and On job training and Practical Demonstration for Chemical and Instrumentation (Format No.BDI-QCSG004F19). Analysis of In process, SFG, Finished Goods, Raw material & stability sample, Analytical method validation/Verification, of OSD and LVP as per defined Protocol or procedure and related documentation as per GLP and GMP in time. Responsible for receiving sample and their documentation. Responsible Data entry in SAP. Responsible for sending the sample to outside laboratory and ensure their analysis as per requirement from Outside Commercial Lab as and when required. Calibration of instruments, as and when required. Preparation of volumetric solution, reagent, and test solution, as and when required. Ensuring the timely updation in the documents as per the Pharmacopeial amendments. Responsible for maintaining the resource in the quality control department. To ensure the compliance of the requirement of cGDP/cGDP and Data integrity while performing all activities in the laboratory. Ensuring the Compliance to EPD Global Guidelines. Facing internal and external audits and ensuring compliance. Implementation of GLP / GMP requirements. Coordinating and aligning the practices and procedures in line with the COBC requirements. SOP training in Isotrain of self-train within stipulated time. Any other task assigned by reporting manager. In absence of the position holder, the sub-ordinate Executive / Manager working in the section, or the authorized designee (as applicable) shall be responsible for day to day working.

Role & responsibilities Quality Control: Conduct regular inspections of raw materials, production processes, and finished products to ensure compliance with quality standards and regulations. Documentation: Maintain accurate records of all quality control activities, including test results, inspections, and corrective actions taken. Food Safety Compliance: Ensure compliance with all relevant food safety regulations and standards, including HACCP, FDA regulations, and company policies. Process Improvement: Identify opportunities for process improvements to enhance product quality, efficiency, and safety. Investigation and Resolution: Investigate any quality issues or customer complaints, and implement corrective and preventive actions as necessary. Audits and Inspections: Prepare for and participate in internal and external audits and inspections, ensuring compliance with all regulatory requirements. Continuous Monitoring: Implement systems for continuous monitoring of critical control points and key performance indicators to maintain product quality and safety. Preferred candidate profile Candidates with knowledge of food technology - Quality Department Responsible for handling all quality related works like QA/QC etc. Prefer candidate from FMCG -Food Industry Only This is a shift-based role, and candidates must be willing to work across all three shifts. Excellent knowledge in MS Office. Excellent documentation and presentation skills. Must possess proficient written and verbal communication skills.

1. Utilize a broad understanding of cGMP to provide QA support, mentoring and coaching for Operations, Analytical, Logistics and Engineering departments to assure that activities are undertaken in compliance with cGMP and procedures, as appropriate. Required Candidate profile GMP PRO/DATA NIJNA/BMR/ANNUAL PRODUCT REVIEW/MBR/CLEANING VALIDATION

1. Business Growth & P&L Ownership Deliver revenue and EBIT targets across enterprise and strategic healthcare accounts. Lead high-value customer acquisitions, large RFPs, and key deal closures. Drive sector-specific growth strategies, ensuring improved EBITDA contribution. Retain 70%+ of enterprise accounts by volume and profit contribution. 2. Strategic Sales & Market Penetration Identify and convert new business opportunities across core healthcare verticals. Own the complete sales lifecycle: lead generation, pitch, proposal, negotiation, and closure. Leverage CRM tools for pipeline tracking and sales governance. 3. Customer and Market Development Build and nurture relationships with senior stakeholders including CXOs, procurement heads, and supply chain leaders in the healthcare ecosystem. Stay updated on healthcare regulations (e.g., GDP/GMP), industry shifts, and logistics innovations to proactively identify new opportunities. Represent DP World in relevant industry forums and conferences to strengthen the company s position in the healthcare space. 4. Collaboration & Cross-BU Integration Drive integrated offerings by engaging with at least 2 Business Units (BUs) to deliver holistic healthcare supply chain solutions. Ensure accurate commercial documentation, quote approvals, and pricing governance as per internal protocols. Collaborate with platforms like Trade Finance to offer value-added solutions for clients. 5. Client Engagement & Retention Build and manage CXO-level relationships with procurement and supply chain leaders. Conduct Monthly and Quarterly Business Reviews (MBRs/QBRs) to drive client satisfaction and unlock upsell opportunities. Work closely with internal teams (operations, finance, customer service) to ensure seamless onboarding and delivery. 6. Commercial Excellence & Reporting Lead contract negotiations with a focus on profitability and customer expectations. Track and report key sales KPIs, including pipeline status, win ratios, EBIT margins, and retention rates. QUALIFICATIONS & COMPETENCIES Master s degree in supply chain, Logistics, Business, or related field preferred. Minimum 6 years of experience in logistics with at least 4 years in Logistics Sales Strong commercial acumen with experience managing large P&Ls and sector portfolios. Hands-on experience with enterprise/strategic account development and cross-functional collaboration. Attributes: Attention to detail, execution-focused, persistent, and highly customer-centric. Strong understanding of at least some of the following: Contract Logistics, Cold Chain, Rail, Freight Forwarding, and Free Trade Warehouse Zones (FTWZ).

Role : Shift Manager Location : Bhiwandi, Mumbai Job Purpose/Overview Job Purpose of Shift Leader is to lead shift team , both packing operator and the maintenance operator , to produce right product and required volume with Safety and Quality by enabling Senior Operator s leadership on the floor as well as team/each packing operator and maintenance operators development. Closely work with the maintenance Manger who will oversee the site maintenance and CAPEX activity and its planning. Shift leader reports to the Plant Manager who owns entire operations as key responsibility and part of Operations Leadership team to own entire Operations team performance and engagement. Key Responsibilities Key responsibilities of Shift Leader are To ensure safety, quality procedures for shift team members during his/her shift To set period target and own the result for the team on core KPIs like safety, quality and productivity. To set team vision and direction to deploy and support the team to achieve/follow. To cultivate Continuous Improvement culture through FMOS for Safety, Quality and Productivity. To support project (CI, Engineering) Job Specifications/Qualifications 1. Education Professional Qualification (Industrial) Engineering and/or supply chain bachelor/master is preferred 2. Knowledge/Experience 7+ experience in manufacturing (great if FOOD product, ISO9000/22000, GMP-GHP, HACCP) 3+ yrs leadership (people/team management) experience is mandatory 3. Physical/Mental Requirements Safety first, focus on Quality, good communication to the entire team, fairness to the team members Strong both physical and mental health

Role & responsibilities 1. Manage and oversee store operations at the formulation plant. 2. Ensure compliance with Good Manufacturing Practices (GMP) in all store activities. 3. Maintain accurate inventory records using computer systems; strong computer knowledge is essential. Lead, guide, and supervise the stores team for efficient workflow and coordination.

Key Responsibilities: Equipment Design & Selection : Design and specify process equipment systems for pharmaceutical manufacturing plants, ensuring alignment with the project goals and regulatory standards (e.g., GMP, FDA, EMA). Select appropriate equipment, considering factors such as material compatibility, process requirements, automation, and cost-effectiveness. Develop equipment specifications, datasheets, and technical documentation for procurement and installation. Having hands on experience for installing isolator-based filling line. Line manufacturer is Bausch + Straubel, Syntegon, Steriline. Project Execution & Management : Lead or support the execution of process equipment projects, including installation, commissioning, and qualification. Develop project plans, timelines, and budgets for equipment-related projects, ensuring the completion of all milestones on time and within scope. Coordinate with external vendors, suppliers, and contractors to ensure timely delivery and installation of process equipment. Oversee the installation and commissioning of new equipment and systems, ensuring smooth integration into existing operations. Qualification & Validation : Lead or support the qualification (IQ/OQ/PQ) and validation activities for process equipment to ensure it meets GMP and regulatory requirements. Ensure that all necessary documentation for equipment qualification, including protocols and reports, is completed and stored per regulatory requirements. Conduct risk assessments for equipment and identify potential failure modes or performance issues. Maintenance & Troubleshooting : Support the maintenance and troubleshooting of process equipment, addressing issues that arise during production or operations. Identify and implement continuous improvements to equipment reliability, performance, and lifecycle management. Develop maintenance schedules and ensure the timely servicing and calibration of critical equipment. Compliance & Documentation : Ensure that all equipment complies with the relevant industry standards, such as cGMP, FDA, EMA, and other local regulatory requirements. Maintain detailed technical documentation, including equipment manuals, maintenance records, and calibration logs. Review and update standard operating procedures (SOPs) for equipment operation and maintenance. Collaboration & Cross-Functional Work : Collaborate with process engineers, production teams, quality assurance, and regulatory teams to ensure equipment meets operational and regulatory requirements. Work closely with procurement teams to ensure proper specifications and sourcing of equipment. Training & Knowledge Sharing : Train operators and maintenance personnel on the proper use, maintenance, and troubleshooting of process equipment. Stay updated with the latest developments in pharmaceutical equipment technologies and industry best practices. Share knowledge and best practices with the team and mentor junior engineers.

Select with space bar to view the full contents of the job information. Executive - Quality Systems Job Details | AdvanzPharma We use cookies to offer you the best possible website experience. Your cookie preferences will be stored in your browser s local storage. This includes cookies necessary for the websites operation. Additionally, you can freely decide and change any time whether you accept cookies or choose to opt out of cookies to improve the websites performance, as well as cookies used to display content tailored to your interests. Your experience of the site and the services we are able to offer may be impacted if you do not accept all cookies. Modify Cookie Preferences Reject All Cookies Accept All Cookies Select how often (in days) to receive an alert: Select how often (in days) to receive an alert: Andheri (East), IN, Mumbai 400 ADVANZ PHARMA is a global pharmaceutical company with the purpose to improve patients lives by providing and enhancing the specialty, hospital, and rare disease medicines they depend on. Our ambition is to be a partner of choice for the commercialisation of specialty, hospital, and rare disease medicines in Europe, Canada, and Australia. In line with our ambition, we are partnering with innovative biopharma and pharmaceutical development companies to bring medicines to patients. Headquartered in London, UK, we have c700 employees based across more than 20 countries, including key countries in Europe, the US, Canada, and Australia. Our Centre of Excellence in Mumbai, India, as well as an established global distribution and commercialisation partner network complement our global operations. ADVANZ PHARMA s product portfolio and pipeline comprises innovative medicines, specialty generics & biosimilars, and originator brands. Our products and pipeline cover a broad range of therapeutic areas, including hepatology, gastroenterology, anti-infectives, critical care, endocrinology, CNS, and, more broadly, rare diseases. We can only achieve our ambition with the passion of our dedicated and highly qualified people, acting in line with our company values of entrepreneurship, speed, and integrity. About the Role As ADVANZ PHARMA continues to strengthen its position as the partner of choice for specialty, hospital, and rare disease medicines, we have an exciting opportunity for an Executive- Quality Systems. Execute Complaints investigations in accordance with the defined procedures ensuring that: Complaints are raised in the system. Complaints are investigated to the required standard and that root cause is identified (leading to appropriate CAPA). Complaint s resolution is appropriately documented with supporting evidence. Liaising with CMOs and relevant stakeholders to ensure that complaints are investigated, resolved and closed in a timely manner. Interact with complaints reporter in the course of investigations and communicate the outcome of investigations accordingly. Follow up with CAPA owners to ensure that actions are implemented in a timely manner. To assist in executing Recalls as required. To assist in investigation of deviations when required. Creation of Quality related documentation (SOPs, Risk Assessments etc.) Carry out internal audits as required. Report Quality Systems metrics. Other activities as may be required, at the discretion of management. Thrive in an entrepreneurial environment and take accountability for results. Embrace challenge and change, applying a growth mindset approach. Have a bias for action and fast decision making. Consistent demonstration and embodiment of company core values: Entrepreneurship, Speed, and Integrity. Drive the spirit of One Team by working collaboratively across all business functions with an open, honest, and respectful cooperation. Contribute to making ADVANZ PHARMA a desired place to work. We are looking for highly motivated individuals who are passionate about making a meaningful difference to patients lives. For this role, you will also have the following: Qualifications: Minimum Honors Degree in Chemistry, Pharmacy or Microbiology. Knowledge, Skills & Experience: Decent experience of working in a similar role within a pharmaceutical company. Ability to use eQMS (eg. TrackWise, Veeva Vault etc.) for Quality Systems management. Knowledge of ICH Q9, ICH Q10 and Eudralex- Volume 4 Good manufacturing practice (GMP) guidelines. Capable of working to deadlines & remain calm under pressure. Good working knowledge of MS Office. Well organised with logical & methodical approach to work. Excellent communication skills, both oral and written, to include senior management where escalation is required. A positive and can-do approach , biased towards finding solutions and embracing change. Inspired by our values of entrepreneurship, speed and integrity. Learning agility and scalability , with a desire to continuously improve and develop as ADVANZ grows. Work collaboratively across all business functions with an open, honest, and respectful cooperation. Ability to have fun and thrive in a growing, unique, and inclusive work environment. The success of any company is driven by its people, and we are no different. At ADVANZ PHARMA, we believe in empowering our people to be entrepreneurs and embrace challenges to enable personal and company growth in an agile and fast-paced environment. We strive to do that inclusively and responsibly, treating all employees with integrity whilst rewarding outcomes and impact. Our teams are made up of people from all walks of life and backgrounds. We thrive in an environment where uniqueness is celebrated, but we are all united by the same passion to help improve patients lives by providing and enhancing the specialty and hospital medicines they depend on. But there s more to you and us than just work, which is why our culture, vision and values are so high on our agenda. We believe in gender equality and actively encourage women into senior roles we have an active ADVANZ PHARMA Women s Network; almost 40% of our managers are women. We work hard to recognise and reward talent, and we actively promote from within - last year, approximately 25% of our people across the company achieved promotions. In addition, we recognise talent with our annual Impact Awards, in which our top performers are rewarded for their hard work and dedication. We offer flexible, agile working options, and you will also enjoy a highly competitive salary and benefits package. *Please include a CV and Cover letter. When you visit any website, it may store or retrieve information on your browser, mostly in the form of cookies. Because we respect your right to privacy, you can choose not to allow some types of cookies. However, blocking some types of cookies may impact your experience of the site and the services we are able to offer. These cookies are required to use this website and cant be turned off. 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Job Description: Key responsibilities: Accountable for All planned Electrical Control maintenance tasks (scheduled & emergent) relevant to dry pet food process, packaging, utilities rotating, and ancillary equipment includes solids conveying/ liquids transfer pumps, hydraulic systems, Fall protection equipment, HVAC and fire protection systems Execute PM work orders, responsible for LV/ELV Electrical and control cabinets planned preventive maintenance tasks completion as per schedules and closed in SAP PM tool. Responsible for Process and utility area Instruments calibrations completion assigned through SAP PM Tool and closure. Permitting compliance with safety requirements, liaison and coordination with other Functions to execute breakdown and Progressive maintenance tasks Perform Routine PM checks includes clean, inspect, lubricate, IR tests, current injection tests and thermography measurements on designated electrical switch gear/Motors and recording of all readings includes preliminary reportage on found conditions Ensure Measuring instruments and control systems, all electronic devices used in automated process are maintained and working properly. Perform basic programming modifications ladder logic for plant automation systems (Rockwell), operates PLC, s &Vfd,s, and ensure proper operation of SCADA systems Identify potential or existing Flaws in the automated electrical and control architecture, perform trouble shooting, offering suggestions for reliability improvements Ensure legal and company compliance for electrical and control systems by testing and upkeep of all records. Document startup processes during installation of electrical and electronic devices on existing and new Plant equipment Provide line support, including attendance at relevant ops/technical day review meetings and shift Handover meetings. Responsible for implementation of 5S in the work area Maintenance spends of his respective area not to exceed Operating Plan. Progress to be tracked every period including use of commitment. Ensuring Electrical and controls spare parts availability for scheduled and projected jobs inclusive of spare inventory (physical) checking and stock inspections and preliminary liaison with Suppliers and Vendors for proposals etc. Maintains MTBF&MTTR records and equipment history cards data. Electrical & control Problems Trouble-shooting, produce data for Basic Root Cause Analysis and Development of Solution Participates in the technical change management process. Always ensure all safe working practices around Moving and electrical equipment being followed Offering suggestions and Own Energy conservation, cost reduction, quality improvement activities Role in Plant emergency organization Quality- Associate is responsible to ensure effective implementation of Mars QMP (Quality Management Process), Quality and Food Safety requirements including Personnel Hygiene and GMP stated by the Organization as applicable. Associate shall deliver through Respective Area/Process Standard Operating Procedures. Meet basic competency requirements mentioned in the job Role Skill Matrix to ensure Quality and Food Safety requirements are implemented to satisfactory level. SES-Overall responsibility to ensure the individual compliance to Mars Global/Asset conservation standards and another relevant local SES legislation. Responsible for implementing and maintaining all relevant SES Management systems in their respective work area. Responsible for understanding risks and controls in their area, get appropriate training, report all incidents and ensure that SES objectives are captured as KRAs in TMS This associate is the senior maintenance associate on site as such is responsible for all respective reliability and infrastructure issues (buildings, utilities, safe conditions etc. Duties also include: Maintain the reliability-planning tool SAP PM. Close liaison with operations planning to ensure correct integration of planned maintenance activities. Tracking documentation for all maintenance planned activity completion. What can you expect from Mars Work with diverse and talented Associates, all guided by the Five Principles. Join a purpose driven company, where we re striving to build the world we want tomorrow, today. Best-in-class learning and development support from day one, including access to our in-house Mars University. An industry competitive salary and benefits package, including company bonus. Mars is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, protected veteran status, or any other characteristic protected by law. If you need assistance or an accommodation during the application process because of a disability, it is available upon request. The company is pleased to provide such assistance, and no applicant will be penalized as a result of such a request.

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, R&D, 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 Planning and executing various analytical method development, validation for new products, comprehensive testing of API and finished dosages with all established regulatory and compliance and safety requirements. Review of laboratory data, instrument logbook and reports wherever applicable. Initiation of departmental CCRs and tracking the progress to execute the proposed changes through QMS system. Preparation of TAP (Transfer of Analytical Procedures) protocol and Report for various sites. Procuring respective samples and Impurities accordingly. Planning and executing the assigned TAP projects to various sites. Preparation, maintenance and archival of regulatory submission documentation like SOP, protocols, reports for method development and validation. Job Responsibilities Prepares working plan for assigned projects and provides timeline to Deputy Manager. Develops stability indicative analytical methods for drug substance and finished product Responsible for all activities in Analytical Development, including cGLP, documentation and implementation of departmental quality systems. Responsible for protocol preparation, planning, execution, review and report preparation of various analytical method validation parameters. Ensures analytical methods validation is conducted according to approved validation protocol in a timely manner with accuracy and precision in compliance of laboratory SOP and guidelines. Responsible for method verifications and publishing of analytical methods Maintenance and archival of analytical method validation documents. Performs all analytical tests for drug substance, including assay, related compounds, identifications and wet chemistry for API evaluation. Performs all analytical tests for PE/PO samples, including assay, degradation products and dissolution. Performs all analytical tests for API releasing, including assay, degradation products, dissolution and physical testing. Conducts other tests required for dosage submissions. Conducts lab investigations for OOS and OOT results. Raising Change control for various analytical activities (Method SOP and department SOPs)by QMS trackwise To prepare General, Operation and Calibration Standard Operating Procedures. Responsible for initiation, execution and completion of technology transfer and collaborative validation activities of analytical methods to and / or from other departments of Apotex wherever applicable. Responsible for technology transfer and Transfer of analytical procedures activity to support the supervisor. Communicating the requirements for the Leaders and within the team members for effective cGLP procedures and departmental quality systems to achieve all outcomes. With guidance of scientists, performs troubleshooting on complex issues with respect to the stability of drug substances and drug products. To participate in the mandatory trainings to execute the day to day job responsibilities. Develops and maintain strong relationships within Analytical R&D to ensure that the projects are delivered on time. Practice and up-gradation of knowledge with respect to cGMP. Performs all work in accordance with all established regulatory and compliance and safety requirements. Participates in departmental housekeeping and other pertinent duties as assigned in accordance with safety and GMP requirements. Ensures all instruments assigned with responsibility within group/department are well maintained. Work as a member of a team to achieve all outcomes. Works in a safe manner collaborating as a team member to achieve all outcomes. Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion. Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies. All other relevant duties as assigned. Job Requirements Education A graduate/post graduate in analytical chemistry, organic chemistry, pharmaceutical sciences, or related field. Knowledge, Skills and Abilities knowledge of the instrumentation such as HPLC, GC, spectrophotometer and dissolution apparatus, wet chemistry and analytical bench techniques. Knowledge in HPLC method development and method validation. Knowledge on preparation and review of various documents like SOPs, Formats, Protocols, Reports, analytical data, investigation and deviation reports. Should have well versed knowledge on regulatory guidelines and thorough knowledge on cGMP activities Should possess troubleshooting knowledge on Instruments and analysis. Knowledge of wet chemistry, analytical bench techniques, Window-based software, and automated data acquisition systems. Working knowledge of LIMS is an asset. Good written and verbal English communication skills. Experience BSc with 5 years or MSc with 3-4 years experience in a pharmaceutical lab in an R&D environment. Chromatographic method development and validation. 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.

Strong knowledge of cGMP regulations, quality management systems, and industry best practices. Exposure to international regulatory inspections like USFDA, EDQM. Exposure to international regulatory inspections like USFDA, EDQM Required Candidate profile Bachelor’s degree in pharmacy or master’s degree in chemistry from a recognized university.6-9 years of experience in quality assurance roles within the pharmaceutical or API manufacturing industry.

*Manage molding operation & team targets *Oversee molding, tool changes, maintenance & records *Plan schedules for efficiency & minimal downtime *Coordinate with Quality, Maintenance & Production *Resolve issues, cut rejections & improve cycle time Required Candidate profile *Ensure GMP, quality & process compliance *Skilled in leadership, team management & planning *Knowledge of lean methods & quality systems *Familiar with Kaizen, 5S & continuous improvement

Drug Discovery - In Vitro Pharmacology: Ph.D. in Bio-chemistry / Molecular Biology / Pharmacology / Biotechnology with 10 years industry experience or Ph.D. + post-doctoral fellowship with 6-8 years in drug discoveryresearch. Knowledge: Good understanding of overall drug discovery process; exposure to multiple therapeutic a reas In-depth understanding of all aspects of in vitro pharmacology as applicable to new drug d iscovery Basicunderstanding of biologics development like mAbs, ADC, etc Skills: Ability toestablish cost effective biochemical and cell based assays by using differentkinds of readouts like absorbance, luminescence, fluorescence and HTRFtechnologies. Ability to screenNCEs in biochemical and cell based assays Statistical applications and dataanalysis Good communication and management skills Competencies: Expertise and specializationin developing target based biological assays for NCEs and their screening Ability toinitiate, test and adapt new assay and screening methodologies Focused; driven to finish set goals within strict timelines