ResponsibilitiesTo approve analytical COA & test plan in LIMS.  Responsible to review Audit trail of laboratory instruments and software like EWS, Empower, LabX etc. To release/Approval of the RM/PM in SAP HANA and Analytical technology transfer/validation /development etc. Responsible to provide a data of OOS/OOT/Lab Event/FAR/OOC/CAPA/Recall for Quality Council/ R&D Team as applicable. Responsible to provide analytical data for annual quality review as applicable. Responsible for verification of qualification and training record of Laboratory Analysts. Trending of QA observations from raw data review and suggest for improvement. Approval of stability protocol, Method Transfer protocol/report, Method Validation Protocol / report, stability summary report. To review Pharmacopeia – Evaluation and Equivalence Report. To perform the trend analysis of OOS/OOT/Lab Event/QA of QC observation and evaluate the CAPA effectiveness for repetitive Deviation and internal quality observations. To actively participate in cross functional investigation. Review of regulatory query response. To provide technical training with respect laboratory function.  Issuance of template/documents /log books etc. Qualification & ExpeirneceQualification M. Pharmacy /B. Pharma , M,Sc chemistry Experience 10+ years

Responsibilities  Commercial product/ stability batches / exhibit batches / characterization Batches – Master Batch Manufacturing Record and Master Batch Packaging Record.  Risk Assessment, Process Validation protocol, Incident and Investigation report, action, compliance, and closure.  CAPA plan and closure.  Protocols and reports.  Internal Quality Audit/ Regulatory Quality Audit Compliance and closure.  Change, control, Standard Operating Procedure, Planned Modification.  Other quality documents including amendments. To assist the Plant head in Batch Manufacturing, Warehouse and controlling the functions related to General oral solid dosage department. To plan and execute the schedule as per work plan. To ensure the achievement of Production and Warehouse output with respect to Quality and commercial demands.Qualification & ExperienceB.Pharm / M.Pharm Experience Tenure : 19+ Years (with recent USFDA experience & Wrap matrix molecules with Oros technology and Potent Molecules handling)

Responsibilities  Responsible for developing, executing, and maintaining the regulatory requirements for biologicals, as well as managing regulatory commitments  Stay abreast of regulatory agency regulations, directives, guidelines, and policies for biologicals that could impact product development, in order to assess approval pathways and identify potential issues  Ensure lifecycle management through the timely submission of annual reports, supplements, etc., to maintain product continuity.  Support the development, communication, and review of the Regulatory Strategy Document for projects of increasing complexity  Provide regulatory support, as needed, in product in-licensing/due diligence reviews, product divestments, and product withdrawals.  Manage the execution of regulatory documentation, including PIND/IND/IMPD/CTA, original BLA/MAA, agency background packages, and responses to health authority questions, in accordance with established business processes and systems.  Set and monitor submission timelines in collaboration with key stakeholders.  Coordinate with global manufacturing sites and integrate regulatory strategy across those sites.  Provide consistent support to cross-functional teams such as commercial and clinical teams.  Ensure communication with regulatory authorities is conducted in accordance with established departmental procedures.  As applicable, review audit reports, regulatory agency inspection reports, and responses to inspection observations, if any, upon receipt  Compiles, prepares, and reviews regulatory submissions to regulatory agencies, as applicable.  Conduct department-level training, as necessary, to educate regulatory strategists and other roles within the department on regulatory requirements, policies, and procedures.  Participate in the authoring and/or review of departmental procedures/guidance, as applicable. Qualification & Experience M-Pharm in pharmaceutical sciences /M.Tech – Biotechnology / MSc- Life sciences Required Experience And Skills  10-15 years of hands-on experience in regulatory affairs  This role needs a regulatory expert with hands on experience on regulatory activities for NDAs / BLAs, who has the management capability of leading a group of team members 

ResponsibilitiesTo ensure cGMP and compliance review in the manufacturing shop floor and packing areas. To supervision of dispensing activity of manufacturing shop floor and packing areas. To Issuance of Bottle label, Ouster and Medication guide for commercial batch. Rsponsible for providing machine and area clearance. To conduct Sampling of reserve sample, stability sample and In-process checks during execution of batch packaging as per Batch Packaging Record (BPR) and stability study protocol. Online Documents and records review like equipment’s logbooks, dispensing logs, housekeeping records, environmental monitoring records, calibration record, batch records etc.. Calibration of IPQA instruments. Additional Responsibilities Real-time Monitoring and Compliance Reporting. Participation in Investigations. Provide on-the-job training to shop floor personnel on GMP practices, quality standards, and documentation practices. Maintain IPQA-related documents and records in a state of audit readiness. To have good written and verbal communication skills in English language.Qualification & ExpeirenceBachelors Degree (BA/BS) B. Pharm - Required Experience  2 - 4 Years

Responsibilities Manage, control, and maintain all Quality Assurance (QA) documents, records, and logs in compliance with GMP requirements.  Ensure timely issuance, retrieval, archival, and destruction of controlled documents according to approved procedures.  Maintain document revision history and ensure only current, approved versions are available for use.  Coordinate document review, approval, and distribution processes with QA, Production, QC, and other departments.  Monitor compliance with document control procedures and support internal audits and regulatory inspections.  Maintain electronic and physical document management systems, ensuring data integrity and confidentiality.  Track periodic review schedules for Standard Operating Procedures (SOPs), specifications, forms, and quality manuals.  Support change control activities by updating and distributing revised documents as per approved changes.  Prepare document control metrics, reports, and status updates for management review.  Ensure all documentation practices comply with applicable regulatory guidelines, including GMP, WHO, FDA, MHRA, and company quality standardsQualification & ExpeirenceB. Pharm B. Pharm - Required M. Pharm M. Pharm - Preferred Experience: 2 years or more in 2 - 5 Years

Responsibilities Nonclinical safety and toxicology study design & execution -  Design, plan, and conduct in vivo and/or in vitro safety pharmacology and toxicology studies in alignment with GLP principles. Select appropriate species, study duration, and endpoints based on pharmacology, pharmacokinetics and regulatory requirements. Review study raw data, protocols, results and reports.  Oversee study execution, ensure data accuracy, and coordinate with CROs or internal cross functional teams. Risk Assessment & Safety Evaluation -  Analyse and interpret the safety and toxicology data and integrate findings with pharmacokinetics and pharmacodynamics to assess potential safety risks.  Perform toxicological risk assessments including PDE/OEL/ADI derivations, impurity/excipient qualification assessments, extractables & leachables evaluations, and safety margin calculations.  Conduct exposure assessments for process materials, impurities, metabolites, degradation products and excipients.  Regulatory & Documentation -  Prepare and review high-quality safety and toxicology study reports, technical summaries, and nonclinical sections of regulatory submission documents (IND, NDA/MAA, ANDA, eCTD Modules 2.4/2.6 & 4, briefing books and IB, etc.).  Support regulatory filings to USFDA, EMA, DCGI, and other global agencies.  Draft and review regulatory query responses, briefing documents, and expert justifications.  Toxicology Informatics & Literature Research -  Perform comprehensive literature searches using toxicity databases (e.g., PubMed, TOXNET, ECHA, HSDB, etc.,).Qualification & ExpeirenceMaster’s or PhD in Toxicology, Pharmacology, Veterinary Sciences, or related biomedical science discipline. 8-10 years’ experience in preclinical toxicology with at least 5 years as a Study Director in a GLP-certified facility.

ResponsibilitiesExecute production activities in a shift by managing available resources to achieve production target  Execute assigned tasks as per planned production activity to meet production targets for a shift  Regulate usage of consumables in the production process at optimum levels to save costs  Increase the efficiency of area by utilization of equipment and by reducing downtime in manufacturing area Key Accountabilities (2/6) Maintain standard process parameters as per BMRs and other supporting documents for achieving production target and maintaining quality  Ensure all operations are performed as per GMP & Safety norms by reviewing all processes and documents for compliance  Ensure equipment, facility and block premises are maintained as per regulatory compliance  Maintain system integrity by updating documentations and deviations on CipDox while performing operations  Perform validation, qualification and calibration as per schedule and update output of all activities in the systems  Prepare new documents and update existing documents as per GMP requirement Qualification & ExperienceBachelor in Pharmacy Relevant Work Experience  3-4 years of experience with 2 years of experience in pharmaceutical manufacturing  Knowledge of cGMP practices, equipment operations required for Formulation Production

ResponsibilitiesAnalyse samples as per priority and work allocation Review the data as per respective specification, Microbiological Methods and results obtained Prepare, review and submit reports to Team leader within stipulated timelines in order to support individual sample release within stipulated timelines to achieve SLAInitiate investigations and take necessary corrective and preventive actions Investigate incidence & lab error on priority basis so that batch release timely and issues are not recurring Qualification & ExperienceM. Sc (Microbiology) Relevant Work Experience 1-5 years’ experience for analyst and 3-7 years for reviewer in Microbiology Good knowledge of Microbiology, skill to perform assigned task, communication in English

ResponsibilitiesPrevent incidences across Unit to ensure employees and stakeholder¢�s safety Assess and Improve emergency preparedness across Unit to reduce impact of Incidences to human and propertyExecution of the planned Activity, promotional Activity and improvement and Statutory complianceQualification & ExperienceScience graduate in chemistry/ Diploma or Degree with Diploma in Advance industrial safety Relevant Work Experience 2 years of safety experience in Pharma or chemical industries

ResponsibilitiesPerform method transfers/ validations / method verifications to the complex analytical techniques Interpret and evaluate data for accuracy, precision, trends, and potential cGMP impact, recommending appropriate corrective actions. Ensure all documentation and quality records comply with Good Manufacturing Practices and Good Laboratory Practices and are filed according to existing policies. Review and revise Standard Operating Procedures, analytical methods, and related documents to keep them current. Conduct analyses on finished products, raw materials, and components, including data entry, review, and approval in a computerized database. Contribute to the completion of complex projects, manage time effectively to meet targets, and develop plans for work activities within a team, while exercising judgment with reliance on supervisor and working under their direction. Qualification & ExpeirneceMaster’s degree in chemistry/ pharmacy with 8-10 years of experience in Analytical Method Transfer / Validation) Qualified in multiple analytical techniques (HPLC-with Empower, GC, IC, ICP-MS, Potentiometry, UV?Vis, FTIR, Karl Fischer, and pH meters) Demonstrated technical skills in method validation and testing Ability to read and understand applicable compendial methods, Standard Operating Procedures, technical procedures, and governmental regulations Conduct analytical method validation in accordance with ICH Q2 (R1/R2), USP, and EP standards, encompassing protocol preparation, execution, approval of validation summaries, and coordination with cross?functional teams. Conduct test method GAP assessments against USP, EP, BP, and JP requirements for New Product Introduction (NPI).