ResponsibilitiesAt Dr. Agarwal’s Eye Hospital, our values and overall mission are of utmost importance to us As an institution, we are unprejudiced by caste, color, social status, or religion Our belief in integrity, teamwork, and rewarding merit is unwavering and firm And we encourage every member of our organization to take ownership of every professional decision they take.

Qualification & ExperienceQualification: Graduate/ Post Graduate Experience: 2 to 4 YearsNote: Candidates with MT Experience in Radiology is required.

 Responsibilities  Preparation and implementation of SOPs, STPs, formats, and records for injectable operations including cartridge / PFS and isolator-based filling lines.  Execution of document control activities including issuance, revision, and archival.  Initiation and tracking of change controls related to facility, equipment, utilities, and documentation.  Support deviation documentation and investigations during commissioning and qualification phases. - Support CAPA implementation and tracking.  Cross-functional coordination with QA, QC, Engineering, Validation, and Projects teams. Qualification & ExperienceEducation: B.Pharm / M.Pharm / B.Sc / M.Sc Experience: 7–8 years in Injectable / Sterile Operations QMS Preferred Exposure: Cartridge / PFS manufacturing and isolator-based aseptic filling lines

 Responsibilities Lead and implement OpEx initiatives such as Lean, Six Sigma, and Kaizen. Identify, design, and implement process improvement projects across various functions. Ensure all improvement initiatives adhere to GMP, safety, and regulatory requirements. Drive process improvements and cost-saving projects. Monitor and enhance operational KPIs. Collaborate with cross-functional teams for sustainable improvements. Support digital transformation and automation initiatives. Develop and implement training programmes to build a culture of continuous improvementQualification & ExperienceIndustrial Engineer/ B. Pharm  Six Sigma Green Belt/ Black Belt Experience: 7 - 10 years

 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. Qualification & ExperienceB. Pharm B. Pharm - Required M. Pharm M. Pharm - Preferred Experience: 5 years or more in 5 - 8 Years

Responsibilities To plan, organize and co-ordinate in the execution of operation and cleaning of compounding activities. To execute, review and supervise the below listed activities. Line Clearance. Area and Equipment cleaning verification. Initiation of swab request and any other applicable sample requests (As applicable). Initiation of equipment, instrument and area breakdown notifications. Review of executed batch records and equipment/area usage, calibration logbooks. Execution of SAP related activities. Execution and review of in-process tests at different stages of processing. To get the issued batch records, logbooks and to return the completed executed batch records, logbooks to QA. To undergo and participate in relevant department and cross functional trainings (as and when assigned) in learning plan. Creation, Control, Maintenance and Revision of Equipment Master Recipes as per SOP. To be a Qualified visual inspector as per Qualification process to handle necessary activities in compounding section. To work inline with the cGMP requirement like (but not limited to) equipment and area status Labelling, environmental conditions and pressure difference monitoring, Weighing, daily area sanitization and cleaning monitoring, audit readiness and Hygiene practices to be followed. To prepare daily reports of production activities, achieving production schedules and daily meetings.Qualification & ExperienceMinimum qualification - B.Pharm/M Pharma. Knowledge, Skills and Abilities Proficient knowledge of Good Manufacturing Practices (GMPs) & Good Documentation Practices. Efficient communication, strategic thinking and problem solving skills. Adequate knowledge to understand the written procedures and policies. Experience Minimum 4 to 6 years of experience in the production process.

Responsibilities Creating SDTM and ADaM datasets for the studies conducted by Apotex using CDISC standards Annotation of CRFs for the clinical studies conducted by Apotex. Development and validate of in-house SAS programs in line with the quality standards and regulations. Ensuring the validation of software’s are done in line with the applicable company quality standards and regulations Validation and review of clinical trial data. Creation of Specifications for Define.xml, Validation and review of SDTM, ADaM, and Define.xml. Creating data sets, tables, listings and Procedural comparison, sorting of source data. Ensures that assigned work is performed in accordance with GCP, GLP, SOPs, regulatory requirements, best practices and established safety standards as applicable Prepare justification for queries from regulatory agencies and tracking of regulatory deficiencies Conduct pharmacokinetic and statistical analysis of concentration-time data of bioequivalence studies in compliance with Standard Operating Procedures (SOPs). Generation/review of randomization schemes Preparation and/or review of 100% snapshot data. Preparation and review of pharmacokinetic/statistical section of Bio-study Reports in accordance with different regulatory guidance (e.g. FDA, TPD and EMEA etc.). Preparation Protocol Synopses and review of in-house and CRO Protocol. Preparation of comprehensive summaries of pharmacology/toxicology information and other document necessary for regulatory submission. Assist in study feasibility exercise for new projects to conduct bioavailability and bioequivalence studies. Request and maintain the controlled copies including co-ordination with QA team. Maintain, update and archive study related files and documents. Works 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. Qualification & ExperienceAt least 4-5 years of industry experience in clinical trials related submissions for different regulatory agencies.

Responsibilities Contributes to decision making on study design, data collection, and analysis by independently recommending appropriate statistical methodology, ensuring alignment with study objectives and regulatory guidelines. Oversees sample size determinations for unique or complex experimental and validation protocol designs. Contributes to the development and authoring/review of the statistical methods section of unique or complex protocols and reports, and writes statistical analysis plans, when necessary. Works with internal stakeholders to define specifications and acceptable ranges. Determines point and interval estimates and applies sound statistical methodology in performing risk assessments and optimization/validation plans. Investigates out of specification or out of trend results. Leads projects providing statistical support for to evaluate any changes during the life cycle of a product. Such changes may include formulations, analytical method, raw materials, and manufacturing processes. Oversees statistical activities, such as JMP, of more junior staff. Liaises with internal stakeholders to determine data attributes, or formatting, required to obtain data for tables, listings and figures. Contributes to the preparation of statistical justifications, and writes responses to complex issues, applying concise, creative and sound scientific and statistical interpretation of literature or data, often with a tight deadline. Provides professional and technical advice in statistics with the ability to mentor more junior staff and explain statistical concepts to non-statisticians to enhance their understanding.Qualification & ExperienceGraduation in Mathematics (Statistics) or related Pharmaceutical/Engineering subjects.Experience: Minimum of Eight years of successful working experience in a regulated industry (preferably Pharmaceutical) with related experience in supporting statistical analysis and evaluations.

ResponsibilitiesLiterature search and study designing of Bioavailability and Bioequivalence studies of oral & non-oral products towards different regulatory submission. Review of BA/BE study protocol and provide Pharmacokinetic (PK) inputs into the study protocols  Coordinate with the CRO for finalizing pilot and pivotal biostudy protocol for DCGI BE application. Develop protocol for patient based BA/BE studies & PD end point study for complex generics. Perform PK and Statistical analysis of in-vivo data obtained from BA/BE and pharmacokinetics studies using Phoenix Software. Use modeling & simulation tools for study optimization. Respond to regulatory queries related to PK analysis and study interpretation.Qualification & ExperienceGraduate : M.Pharm /Pharm D Experience Tenure : Minimum 3 years of relevant experience

ResponsibilitiesThe candidate is expected to develop Surface Plasmon Resonance (SPR) based methods to measure the kinetic and equilibrium binding constants for protein and peptide products. Responsible for analytical method qualification for all pipeline products. Characterization of innovator product batches sourced from different geographical region and preparation of qualitytarget profile. Analytical similarity assessment of in-house products. Preparation of method development reports (MDR) and analytical test procedures (ATP). Responsible for operating and maintaining analytical laboratory in compliance with GLP regulations. The candidate is responsible for the operation and maintenance of the SPR instruments  To manage chemicals,consumables & critical reagents inventory. Performs calibration of instruments and equipment. Troubleshoots instrument performance and equipment issueQualification & ExperienceM.Sc. Experience Tenure : 2-4 yrs