Qualification & Experience          Experience Required :Skin Clinic relevant experience.       Qualification Required : Graduate         

Responsibilities To receive and understand the technology from FnD dept. To design optimisation for process parameters & participate in the trials at R&D. To transfer the technology from R&D to receiver’s site for the respective product. To monitor the TT demo / exhibit/scale up and optimization batches. To review the technical information sheet, product detail, raw material/accessories/ equipment requirement for plant trial/SU/Exhibit batches. To propose and fix the batch size i.e. of the Demo, Scale up, Exhibit and Commercial based on Equipment Capacity/Qualification, Scale Up factor calculations & annual requirements. To get involved and observe in the TT demo batch with F&D. To take scale up batch at manufacturing locations and prepare scale up batch protocol, Scale Up Reports, MFC, Sampling Protocol, Risk Assessment etc. To take the exhibit batches at the manufacturing locations and take care for its trouble shooting. To prepare the summary reports. To perform investigation for Deviation/ OOS/ OOT observed during SU/EB at plant. To prepare agency query responses.Qualification & ExpeirenceExperience : 2-8 Years (Experience of US & Europe markets would be preferred)Qualification : M.Pharm.

ResponsibilitiesEstablishing lab infra at Pune location Procurement of instruments and lab setup Calibration of instruments updating of master list and storing in EDMS preventive maintenance of devices in the lab preventive and annual maintenance of environmental and altitude chambers, qualification of labs Regular data entry of environmental data at various labs at Pune (Baner 6th floor, 5th floor and Chakan lab) Establish Chinchwad lab (move existing infra to this site) Add supplier to ASL as per the need Facilitate instruments transfer from outside India to Pune labs following established government regulations and be compliant with the process Maintain inventory of devices and accessories at central warehouse for S&RC BU Movement of devices, instruments and accessories between warehouse and labs within Pune Calibration of instruments with respective calibration agencies within India and abroad Co-ordinate with logistics for various shipments related to lab to and from IndiaQualification & ExpeirneceBachelor's / Master's Degree in Mechanical Engineering, Minimum Required Experience Minimum 2 years of experience in medical devices lab admin and total of 6 years of experience as minimum in similar experience

Responsibilities Engineering QA Oversight Provide QA Oversight For: Equipment (manufacturing and packing machines) Utility systems (HVAC, Purified Water, Compressed Air, BMS) Ensure engineering activities comply with cGMP and internal SOPs Review and approve engineering-related documents  Qualification & Validation (CSV/Equipment/Utilities) Review And Approve: DQ, IQ, OQ, PQ protocols and reports Equipment and utility qualification documents Ensure: Qualification activities are scientifically justified Traceability from URS to qualification stages Verify equipment is fit for intended use  Calibration & Preventive Maintenance Oversight Review And Approve: Calibration schedules and reports Preventive maintenance (PM) plansQualification & ExperienceB. Pharm/ M. Pharm/ M.Sc. With relevant experience in pharma. Must have knowledge of working on the engineering shop floor as an in-process quality assurance.

ResponsibilitiesManufacturing deviations (granulation, compression, coating, packing) Engineering incidents (equipment breakdown, utility failure, HVAC issues)Atypical events and process interruptionsEnsure investigations comply with cGMP and regulatory expectations (US FDA/MHRA)Challenge weak or unsupported root causes (e.g., generic "operator error"). Scientific Evaluation & Decision MakingQualification & ExperienceMust-Have Skills: B Pharmacy/ M. Pharmacy Must have knowledge on handling manufacturing and engineering investigations. Good analytical and problem-solving skills

Responsibilities Engineering QA Oversight Provide QA Oversight For: Equipment (manufacturing and packing machines) Utility systems (HVAC, Purified Water, Compressed Air, BMS) Ensure engineering activities comply with cGMP and internal SOPs Review and approve engineering-related documents  Qualification & Validation (CSV/Equipment/Utilities) Review And Approve: DQ, IQ, OQ, PQ protocols and reports Equipment and utility qualification documents Ensure: Qualification activities are scientifically justified Traceability from URS to qualification stages Verify equipment is fit for intended use  Calibration & Preventive Maintenance Oversight Review And Approve: Calibration schedules and reports Preventive maintenance (PM) plansQualification & ExperienceB. Pharm/ M. Pharm/ M.Sc. With relevant experience in pharma. Must have knowledge of working on the engineering shop floor as an in-process quality assurance.

Responsibilities Ensures that all allocated projects are carried out in strict accordance with the relevant protocols, global harmonized SOPs, and the specified standards of GCPs. Demonstrates capability to read and follow study timelines for on-time deliverables. Potential to assist with inputs on study design or capable to make suggestions to study timelines when warranted. Assist with review of clinical trial data in accordance with Data Management Plans and/or Data Review Guidelines and raise queries to resolve erroneous, missing, incomplete data. Run and execute additional programs (special listings, reconciliation discrepancy listings, etc.) used to support the review of clinical trial data. Generate, resolve and track queries to address problematic data identified during aggregate data review activities. Interacts with other project team members to support the set-up, maintenance, and closure of the Data Management aspects of the project and attend meetings as required. Generate and QCs data listings for internal data review. May assist or create dummy data to test edit checks and to test database screen design and functionality. Assist or create dummy data to test SAS reports and data listing. Demonstrates the ability to review Edit Check Specifications and Database specifications. Post Data Management documentation and data management related administrative tasks as requested, including maintenance of eTMF as required. Runs study status reports in preparation for Sponsor meetings and to deliver on specific Sponsor request. Assist with the completion of Database Lock and Unlock activities. Supports the training of new staff on project specific Data Management processes. Performs any other duties as assigned. Qualification & ExperienceUniversity / college degree (life sciences, health sciences, information technology or related subjects) or a certification in allied health professions from an appropriate accredited institution. Fluent in English, both written and verbal. Experience (Minimum Required) 3 to 5 years of relevant work experience with increasing responsibility in data management with knowledge of one (1) or more therapeutic areas. Demonstrated time management skill and ability to adhere to project productivity metrics and timelines.

Responsibilities Ensure electronic vendor data contains all protocol specified parameters, is in correct format and data populates to the specified fields and patients correctly. May support LDM in the development of the Data Transfer Agreement and Data Transfer Specifications for vendor data transfers. Review data discrepancies generated by study-specific edit checks for External data and perform the subsequent query management process in resolving the data issues. May support LDM to perform validation review of the electronically transmitted data for a sample of total number of patients in the study for loading purposes. Assist with review of External Data edit checks, External Data status reports and External Data listings. Interact with Clinical staff (CTM/CRA) to obtain local laboratory normal ranges for all sites. Research and resolve discrepant information concerning the normal ranges and maintain proper documentation. Enter and perform QC for local laboratory normal ranges. Verify the normal ranges are properly attached to the patient results in the local lab data collection module of the database. May support LDM to communicate to vendors and client problems involving data transfers, data point issues and validation issues with initial oversite for support of this communication from EDS 2 or above. All other duties as needed or assigned. Qualification & ExperienceUniversity/college degree (life sciences, health sciences, information technology or related subjects) or a certification in allied health professions from an appropriate accredited institution. Fortrea may consider relevant and equivalent experience in lieu of educational requirements. Fluent in English, both written and verbal. Experience (Minimum Required) 3 years prior experience in the pharmaceutical, biotechnology, medical device/diagnostics, or clinical trial industries or an equivalent combination of education and experience to successfully perform the key responsibilities of the job.

Responsibilities  Provide administrative and operational support for global Phase 1–4 clinical trials for NCE products.  Maintain Trial Master File (TMF) and ensure timely filing and quality control of essential documents (ICH-GCP Section 8).  Track study milestones, study trackers, site initiation, patient recruitment progress, and study close-out activities.  Support protocol amendments, Investigator’s Brochure (IB) updates, and Informed Consent Form (ICF) revisions.  Assist in preparation of study-related documents including monitoring plans, site manuals, and training materials.  Support preparation and submission of regulatory and ethics committee packages (IND/CTA submissions, amendments, annual reports).  Maintain regulatory correspondence and submission trackers across regions.  Support safety reporting documentation coordination (SUSARs, DSURs, PSURs).  Coordinate communication with global clinical sites, CROs, laboratories, and vendors.  Assist with site selection documentation, feasibility questionnaires, and site contracts documentation tracking.  Assist in reconciliation of clinical trial documents, data listings, and monitoring reports.  Ensure compliance with ICH-GCP, regulatory guidelines (FDA, EMA, CDSCO), and internal SOPs.  Participate in audit and inspection readiness activities (TMF audits, vendor audits, regulatory inspections).  Collaborate with internal and external stakeholders to implement AI/ML in the department.  Schedule global team meetings, prepare meeting minutes, and track action items.  Support preparation of clinical program reports and management presentations.  Maintain clinical project documentation repositories and version control.  Literature review, compilation, and presentation Qualification & ExperienceB. Pharm B. Pharm - Required M. Pharm M. Pharm - Preferred Experience: 5 years or more in 5 - 8 Years

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. Maintain awareness of other Biometrics functional group deliverables to be able to support risk and mitigation strategies, including impact on DM resources or deliverables and consult with Project Manager (or designee) and/or functional group management as necessary. Keep Project Manager (or designee), Biometrics management team and/or sponsor services informed of pertinent project or sponsor related information (i.e., budget status, work scope changes, timeline impacts). Performs other related duties as assigned by Line Management. Develop and maintain client relationships and review client satisfaction surveys. Track scope changes and work with the Project Manager to ensure that Sponsor approval is received, and the scope change processed. Provides leadership, mentorship, and coaching in DM related clinical trial processes to the internal study team. Provide support to DM managers on the performance evaluation of other team members, provide constructive feedback to aid in career development, interpersonal skills and achievement of competency standards.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. Experience (Minimum Required) 6 to 8 years of DM experience with minimum of 1 years of direct sponsor management.