Roles and Responsibilities An HR and Admin Executive is responsible for all the human resources tasks such as recruitment, training, and employee relations, additionally overlooking administrative duties like office operations, facilities management, and compliance. Manage end-to-end recruitment process from job posting to onboarding new hires. Conduct interviews, assess candidate fitment, and prepare interview schedules. Maintain accurate records of candidate applications, offers made, and joining formalities. Have to Work in Admin Activities. Need to travel to government Offices if needed. Monitor the condition of office infrastructure, including buildings, parking facilities, air conditioning, electricity, water, and other office utilities. Assist departmental heads in setting team goals and aligning them with the organizational objectives.

Manager (Manufacturing) 1.0 Job Description A Production Manager is a key player in the Pharma manufacturing plant responsible for overseeing the entire production process. They manage the production team and make sure everything runs smoothly from start to finish. A Production Managers job description typically includes planning and organizing production schedules, ensuring product quality and safety, managing inventory levels, and ensuring that production deadlines are met. They also work closely with other departments, such as engineering, QA, QC, R&D and purchasing, to ensure efficient and effective production. A Production Manager must have strong leadership skills, be able to motivate and manage teams effectively, and have excellent problem-solving capabilities. They need to have a good understanding of production processes and equipment and possess strong communication and interpersonal skills. 2.0 Job Responsibilities Manufacturing: 2.1 Manufacturing products as per schedule 2.2 Overseeing the manufacturing process, assignment of manufacturing employees. 2.3 Drawing up manufacturing schedule and adjusting schedules as needed. 2.4 Ensuring products are produced on time and are of good quality 2.5 Working out the human and material resources needed. 2.6 Monitoring the production processes 2.7 Being responsible for the selection and maintenance of equipment. 2.8 Monitoring product standards and implementing quality control programs. 2.9 Liaising among different departments, e.g. suppliers and managers. 2.10 Working with managers to implement and meet the companys policies and goals. 2.11 Supervising and motivating a team of workers. 2.12 Reviewing worker performance. 2.13 Identifying training needs 2.14 Involved in the process of validation activities. 2.15 Preparation and review of standard operating procedures related to the manufacturing department and ensure all activities of the department are carried out and documented as per the SOP 2.16 Verification of operation, calibration and maintenance of all manufacturing equipment. 2.17 Verifying of batch manufacturing records, Batch packing records. 2.18 Monitoring the equipment log books, balance logbooks, cleaning logbooks, temperature and air pressure logbooks etc. 2.19 Verification of reconciliation of packing materials and tracking of waste in manufacturing process. 2.20 Monitoring of activities as per calibration and maintenance schedule of production equipment. 2.21 Co-ordination with internal departments like quality assurance, quality control, Material control, FC, Engineering and R&D related to quality issues. 2.22 Monitoring of the packing process. 2.23 Participating in the R&D batches manufacturing process. 2.24 Assure optimization of the Maintenance Organization structure. 2.25 Preparation of preventive maintenance schedules and making sure that schedules are always carried out effectively to ensure the availability of process equipment & utilities. 2.26 Preparation of schedules for calibration of all the process instruments and validation of process equipment as per the SOPs and making sure that calibrations and validations are carried out as per schedule in co-ordination with QA department. 2.27 Preparation of standard operating procedures related to maintenance department and ensure all activities of the department are carried out and documented as per the SOP. 2.28 Preparation & review of documents such as URS, FAT, DQ, IQ, OQ, PQ protocols and reports and monitor its execution in coordination of concerned departments. 2.29 Identifying the training needs and providing training to all maintenance personnel on SOPs.

Job Profile for Regulatory Affairs : Participate and coordinate with various cross-functional teams by working closely with Quality assurance, Quality control for documents collections in dossier preparation. Dossier review and collection of required Pharmacology/Toxicology/Clinical data through literature&internetforpreparationofSummaryofProductCharacteristic and Patient Information Leaf lets (PIL). DMF Review Preparation and Management for submission of dossier in CTD, ACTD and Country specific format. Review of Analytical method validation verification Reports required for drug product development and submission in regulatory application. Review of stability data incompliance with specification. Review of additional stability studies protocols. Responsible for quality review of all documents related to submission. Preparation and Review of Process Validation Protocols and Reports. Preparation and Review of Cleaning Validation Protocols and Reports. Review of Master Specifications, STPs and Worksheets. MSDS, BMR’S, SMPC’s and TSE & BSE certificates Preparation Quantitative and Qualitative formula preparation Certification of analysis (FP), Preparation of Cover letter, declaration forms, Review of Artwork All Technical documents review doing well as per company Requirements SOP ODLS and DCA Portal Apply (Marketing Standard Certificate Additional Products apply Good Manufacturing Practices Certificate (GMP) Good Laboratory Practices Certificate (GLP) Free Sale Certificate on etc. ODLS. Collect documents for COPP application. Making Schedule for dossiers as per requirement of buyer to submit Regulatory Authority. Responding Quires of Dossier arises by the respective authorities. CDSCO - NOC application Documents preparation & applying online.

JOB RESPONSIBILITIES --------------------------------------------------------------------------------------------------- 1) Support for analytical method development and validation. 2) HPLC and GC-Instrumentation, handling and trouble shoot 3) Calibration of HPLC and GC 4) Literature survey. 5) Preparation of SOPs, validation protocol and report. 6) Support for regulatory required testing. 7) Wet analysis 8) Stability analysis, API testing and verification of methods.

1.0 Job Responsibilities 1.1 Preparation and review of SOPs. 1.2 Handling of QMS documents- Change controls, Deviations, Incidents, OOT, CAPA and OOS. 1.3 Handling of Market Complaints, Return goods & Product recalls. 1.4 Review of RM, PM, IP and FP specifications and STPs. 1.5 Preparation and review of Calibration Certificates, COAs. 1.6 Review of Analytical Raw data. 1.7 Review of analytical method validations. 1.8 Responsible for Vendor management- Review of Vendor development documents and approval process. 1.9 Handling of regulatory inspections. 1.10 Audit compliance.

Job Responsibilities Manufacturing: 1. Execute and monitor routine manufacturing activities as per the batch manufacturing record (BMR). 2. Ensure production is carried out in compliance with cGMP, GDP, safety, and company procedures. 3. Operate, clean, and maintain equipment as per SOPs. 4. Maintain online documentation: BMRs, logbooks, cleaning records, and deviation reports. 5. Coordinate with QA/QC, maintenance, and stores for smooth production flow. 6. Monitor in-process parameters and escalate any deviations or abnormal observations to supervisors. 7. Ensure effective material reconciliation at the end of each batch. 8. Participate in internal audits and implement corrective and preventive actions (CAPA). 9. Train junior staff and ensure adherence to production schedules and targets.