ResponsibilitiesStrong hold on drafting, reviewing, and negotiating global contracts with customers and vendors.Interacting with internal and external stakeholder including law firms for various matter globallyLitigation and employment law matters across the globe Experience 3-5 years experience

ResponsibilitiesMonitor daily environmental records and oversee opening/closing of the department. Ensure adherence to GMP and SOP guidelines. Handle and maintain overall serialization activities. Monitor SAP / Stockone entries in the Warehouse Management System. Ensure cleaning of the area and maintain proper records. Update Finished Goods (FG) location records. Manage palletisation and serialization activities. Ensure safe handling of equipment and materials in the warehouse. Maintain daily logbooks accurately. Qualification B.Sc./M.Sc / B. Pharm equivalent.

ResponsibilitiesPerform operation, preventive, and breakdown maintenance of electrical and instrumentation systems for manufacturing equipment, including: Granulation lines (RMG, FBD, Mill, Blender)Dispensing units and material handling systemsCoating machines (Autcoaters)Compression machinesTrack & Trace systemsPrimary packaging areas (Blister, Strip, Bottle lines)Secondary packaging areas (Cartoner, BPU, Case packer, Serialization equipment)Ensure minimum downtime and high equipment availability through timely troubleshooting and root cause analysis.Support continuous manufacturing operations with prompt response telectrical and instrumentation failures.

Responsibilities Responsible to follow GMP and safety practices in the organization.  Analysis of Assay, Related substances, Laser Particle size and Residual solvents of API. Analysis of Assay, Related substances, Dissolution, Blend Uniformity, Content Uniformity of Finished products. Responsible for complainace of GLP & GDP, cGMP- Guideline & ICH Guidelines. Analysis of cleaning validation and process validation. Responsible to perform the task assigned by the HOD as and when required. Skilled at handling instruments such as pH meter analytical balance, Karl Fisher, UPLC, GC, HPLC, Dissolution, Particle size Analyser etc. Maintain training related documentation as per Fortrea and client requirements. Support with onboarding, training and mentoring new associates. Other duties as assigned by management.Qualification & ExperienceBachelor’s in Pharmacy or related science degree (or equivalent); OR Advanced Degree (e.g., PhD or Masters) as applicable. Fortrea may consider relevant and equivalent experience in lieu of educational requirements. Speaking-English and/or other languages as applicable. Experience (Minimum Required) 0-3 Years of experience in the job discipline (e.g. Regulatory Affairs/Quality Assurance/Analytical science / Pharmaceutics / material management and overall drug development and manufacturing process). Technical proficiency with Microsoft Office suite of applications/ Document Management and/or publishing tools.

Responsibilities Perform allied activities such as data collection for report planning, developing strategy, and leading kick-off meetings and round table discussion for comment resolution. Write various safety reports (or part of such reports) for global regulatory submissions, including but not limited to Annual Reports (IND and other), Periodic Safety Update Reports, Periodic Adverse Drug Experience Reports, Development Safety Update Report, Risk Management Plans, and other documents. Take ownership of the assigned deliverables and collaborate with internal/ client stakeholders and the client to get the required inputs. Perform quality review of the safety reports prepared by junior or associate medical writers. Author or contribute to ad hoc reports, benefit-risk evaluation reports, justification/supporting documents for label updates. Write Common Technical Document Summaries including Non-Clinical and Clinical Overviews, Clinical Summaries and other regulatory documents as assigned.Qualification & ExperienceMinimum of first degree in life sciences (or equivalent). Fortrea may consider relevant and equivalent experience in lieu of educational requirements. At least 3 years' experience in the pharmaceutical industry, or at least 2 years of it in medical writing..

Responsibilities Lead studies including (but not limited to) a combination of healthy volunteer and patient populations, multi-site, client management required or reduced timelines. Ability to organize and effectively prioritize workload and deliverables. Be accountable for all DM deliverables as assigned per the established timeline; providing instruction to their DM study team(s) and review of their study team’s output to ensure the highest quality, while adjusting resource allocations accordingly. Ensure that all allocated projects are carried out in strict accordance with the relevant protocols, global harmonized SOPs, and the specified standards of GCPs. Work with the Project Manager(s) to build timelines to meet contracted milestones by communicating with leads in different disciplines and the full project team as necessary, including at study initiation meetings. Provide DM project team leadership and accountability; leads data focused internal project team meetings; meets frequently with the study leads of EDC Design, SAS Programming, Statistics, and PK to ensure that all deliverables are planned and coordinated intradepartmental; proactively identifies potential risks/mitigations, effectively communicates data-driven discussions in order to achieve database lock dates; keeps the Project Manager apprised of project progress.Qualification & ExperienceUniversity / college degree. Fortrea may consider relevant and equivalent experience in lieu of educational requirements. Experience and/or education plus relevant work experience, equating to a bachelor's degree will be accepted in lieu of a bachelor’s degree. Fluent in English, both written and verbal.6 to 8 years of DM experience with minimum of 1 years of direct sponsor management. Experience in handling customer concerns and experience with managing Scope of Work and budgets is preferred.

ResponsibilitiesQuality Management/Continuous Improvement Line Clearance and shop floor compliance Assisting in the Complaint Investigation system at site Assisting in the Qualification and validation system, change control system, deviations Preparing & reviewing the Annual Product Quality Review Review of Batch Manufacturing & Packing Records Coordination of cGMP Training activity. Compliance Ensure adherence to company Quality Standards, Local FDA MHRA regulations, by Qualifications Understanding the requirements Performing the Gap analysis to find out the gaps in the existing system Preparing a compliance plan for the closure of gaps Execution of compliance plans Review of completion for compliance activity Validations & Qualifications: Ensure validated status of all equipment, manufacturing processes, and cleaning processesQualification & ExperienceB. Pharm / M. Pharm from a reputed university Experience 3 to 5 years of similar experience in a regulatory-approved OSD manufacturing large unit.

ResponsibilitiesImplementing a monthly production schedule with consistent quality, adhering to Regulatory, GQS, and HSE guidelines, with proper utilization of resources and optimum cycle time. Performing the production activities in assigned areas to achieve 100 % customer service. Performing the SAP-related activities Able to handle a team consisting of Contractual persons, FTC & Operators in the allocated shift Able to do troubleshooting in the allocated areaQualification & ExperienceM. Pharm / B. Pharm from a reputed university, having 8 to 10 years in the pharmaceutical Primary and secondary packing section, and also exposure in manufacturing in Granulation, compression, and Coating.

ResponsibilitiesImplement daily/Shift-wise production schedules, ensuring that all processes are carried out according to the production plan. Adhering to regulatory, GMP, and HSE guidelines in assigned production areas. Ensure consistent good quality of product by supervising team of operators with effective utilization of resources to fulfill the production objectives in respective unit operations.Qualification & ExperienceGraduate / Post Graduate in Pharmacy with 1 to 5 years of experience in Pharmaceutical Production

ResponsibilitiesProvide technical assessment and strategy for product changes related to design, labeling, raw material, manufacturing support, regulatory compliance, quality improvement and new registrations in collaboration with senior scientists Coordinate and ensure follow-up of technical activities in collaboration with key stakeholders, with respect of project commitment, quality procedures and business needs Provide technical support to authority’s questions in due time Propose options and develop action plan for problem-solving, product and process improvement Establish, maintain and update technical & Design documentation according to Good Documentation PracticesQualification & ExperienceMaster’s in chemistry or M. Pharm. with at least 11 years of relevant experience or Ph.D. in relevant sciences discipline with at least 8 years of relevant experience. Excellent English verbal and written communication skills Exposure to medical devices and drug products