Position : Section Head - Batch Release QA Functional Area: QA Reports to: QA Head Grade: G9B Department: Quality Location: Halol (OSD) POSITION SUMMARY Responsible for IPQA activity and strategy in line with Sun Pharma Compliance, Product Quality Management objectives and Regulatory requirements. Responsible for planning and arranging for internal and external departmental support of quality assurance activities as directed in approved protocols, quality systems or Procedures. Identify and implement solution for improving existing site quality assurance systems and processes Involvement in co-ordination of activities for software like SAP HANA at plant Responsible for review and Approval of Quality management/GMP records. Responsible to ensure and perform site data review of batch records for completeness of documentation, approval and rejection of materials per current good manufacturing procedures and escalation of quality incidences, Continuous process verification (CPV). Manage the batch release function at site wrt documentation, systems, approval and rejection of materials, products at the Site per current Good Manufacturing Practices requirements. The incumbent will assure individual compliance with the all concerned regulatory requirements, GxPs and applicable department programs, including training, documentation, Standard Operating Procedures, and Sun Pharma Global Quality Policies, Standards and Procedures. Key responsibilities: 1. Ensure compliance to regulatory requirements on product, process, equipment and release procedures. 2. Manage Batch release activities for commercial dispatch. 3. Escalate compliance concern to concern stakeholder. 4. Review, compliance of BPR and batch release for commercial dispatch. 5. Review and approve the investigations, CAPA, and effectiveness checks with adherence to timeline. 6. Execute change control and risk assessment whenever required. 7. Ensure Quality Metrics, Quarterly BPR report as per specify timeline. 8. Ensure timely Batch release through electronic system. 9. Planning and arranging for internal and external departmental support of Quality Assurance activities as directed in approved protocols, quality systems or Procedures. 10. Follow the EHS policy and maintain the compliance to GMP requirements. 11.Co-ordination with QPs and customers of different region for batch release. 12.Management of Technical agreement with QP and Customers. 13.Responsible for oversight in warehouse and BSR. 14.Management of retain sample storage , inspection and life cycle management. MINIMUM EDUCATION/EXPERIENCE REQUIREMENTS M.sc / M. Pharm/ B. Pharm 15 years with work experience preferred. REQUIRED SUCCESS ATTRIBUTE Knowledge of GxPs, cGMP and other regulatory requirements. Planning and Prioritization Collaboration Accountability Compliance Customer Service orientation Secondary Success Attributes People Connect Attention to detail Emotional control Effective Communication & Problem solving WORKING ENVIRONMENT/PHYSICAL REQUIREMENTS Incumbent performs work assignments in both normal office and non-aseptic manufacturing/packaging environments. Moderate to loud noise level is common in production rooms. The incumbent must be able to comply with the gowning requirements for entry into controlled non-aseptic manufacturing areas, and wear personal protective equipment as required. This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job. This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.

Role & responsibilities - Candidate Should aware about Peptide Manufacturing Activities. - Good Hands Solid Phase Peptide Synthesis, Cleavage. Handling Rotatory Evaporation Techniques. Purification Techniques by using DAC Preparative HPLC system. - Must have knowledge of Operation of Lyophilizes & Analytical Chromatogram Characterization. Preferred candidate profile Candidates having educational qualification of MSc with Specialization in Analytical / Organic Chemistry / B.E. or B.Tech. (Chemical) with Peptide API experience of 1 to 5 Years.

JD of clinical study report writer ( 3-6 yr experience ) Preparation and review of clinical study report for various regulatory agencies like USFDA, EMA, Canada, ANVISA, ROW market(both clinical and PK-Stat portion) eCTD related activities as per regulatory guidance Preparation of various additional documents (e.g. OGD table, CSBE, BSIF, BTIF etc.) as per respective agency requirement . Handling and archival of finally submitted bio-study reports

Sun Pharmaceutical Industries Limited WALKIN DRIVE @ BARODA Function : MS&T - Injectable Experience : 1 to 6 years Qualification : B.Pharm/M.Pharm Job Location : Halol - Gujarat Date of Interview : 11th May 2025 || Time : 9.30 am - 1.00 pm. Venue of Interview : Sun Pharmaceutical Industries Limited, Near Akshar Chowk, Tandalja Road, Vadodara - 390012 Job Description: Execution of technology transfer to Sun/CMO Site transfer, Scale up, Exhibit, Process validation batches plan with effective planning and utilization of men, materials and machineries. Documentation work like new production introduction form, Scale-up reports, review of Sun/CMO BMR, sampling plan, PV protocol, URS preparation, and Dashboard preparation. To ensure that product is produced and stored according to the appropriate documentation in order to btain the desired quality. Responsible for Review & comments of MF, FMEA, RA & protocol (Sampling plan, Process validation protocol) and compliance. Handling & Support of Trouble shooting batches for data comparison and route cause Investigation at Sun/CMO. Investigation for product trouble shooting To ensure that the Packing operations or activities are carried out on timely. To monitor & prior checkup of equipment planned for usage in Scale up, Exhibit, Process validation batches i.e. Equipment preparation, vial washing & dehydrogenation, CIP/SIP System, PLCs, instruments etc. Responsible for Supervise and perform skid trials for better product development and process improvements and also minimizing manufacturing related constraints in future. To prepare the Scale up report, get evaluated and signed by authorized person prior going to Exhibit batches & their submitted to QA. Responsible to help the officers and operators to standardize production activities to achieve better efficiency and quality. To review validation protocol, SOP and other cGMP Documents. Close coordination with all the supporting departments i.e. Production, NPQC, QA, QE (Engineering) and warehouse for smooth running of Scale up, Exhibit, Process validation batches. To ensure the compliance of various in-process control instructions provided in MF, FMEA, RA, BMR, and MBMR.

This position is accountable for below activities on routine basis. Personnel Hygiene Plant Housekeeping as per GMP requirment Linen Management Pest Control Management To face various audits internal/external related to falities & ensure compliances Vendor Bill checking and processing Contract Labour Management. Induction of new employees. Preparation and implementation of SOP s & Change control Timely closure of QMS Documents To arrange Skill development programme for workmen To arrange the works committee meetings Dealing with site manufacturing and other departments for day to day activities Any other work assigned by HOD

Job Summary Identify key therapy areas / products / complex generics / Sole FTF opportunity for US & OAM markets. Work on various themes to identify low competition ANDA opportunities. Make BC for identified products. Liason with RnD / RA / Clinical / API team / IP / Marketing etc . and compile relevant information. Get Cost of development / capex etc Present shortlisted products to Senior Management for addition to company pipeline, with objectives of achieving the business target and building potential for sustained revenue growth Identify and lead negotiations with CMO / CDMO for novel dosage form products Track Industry news / investor presentations / IMS / new approvals / FTF / Citizen petition opportunities etc and appraise relevant team members. Track novel NDA s of existing molecules (alternate dosage forms & new Strengths) Areas Of Responsibility Lead identification of key therapy areas / products / complex generics / FTF opportunity for US & OAM markets. Track products from the current US & EU pipeline for dosage extensions / alternate Dosage forms. Suggest products for In-Licensing where inhouse manufacturing is not feasible. Prepare and maintain business cases and prioritize projects based on inputs from R&D, manufacturing, network strategies, IP and commercial teams Qualifications : B Pharm / M Pharm + MBA Understanding of Pharmaceutical industry and regulations. Exposure to Drug development and business acumen Technology know how Compliance management Process excellence Execution focus Strategic Orientation People developer Accountability Collaboration Min 8 - 10 years of experience in the pharmaceutical / pharma consulting industry

Job Description: Technical Training Academy Head overseeing training initiatives across a cluster of pharmaceutical sites in India: As the Technical Training Academy Head, you will lead the development and execution of training programs across multiple pharmaceutical sites within a cluster. Your role is critical in enhancing employee skills, ensuring compliance, and driving operational excellence. Here are your key responsibilities: Strategic Planning : Collaborate with senior management to define the vision and strategy for technical training. Align training initiatives with business goals and industry best practices. Training Program Development : Design and curate training content for various roles (production, quality control, engineering, etc.). Develop comprehensive training modules covering technical skills, compliance, and safety. Training Delivery : Oversee training sessions, workshops, and webinars. Ensure effective knowledge transfer to employees at all levels. Quality and Compliance : Emphasize adherence to Good Manufacturing Practices (GMPs) and regulatory requirements. Monitor training effectiveness and address gaps. Resource Management : Allocate resources (trainers, facilities, materials) efficiently. Collaborate with site-specific training coordinators. Stakeholder Engagement : Work closely with HR, department heads, and site leaders. Understand specific training needs for each company. Continuous Improvement : Evaluate training outcomes and adjust programs as needed. Foster a culture of learning and skill development. Qualifications and Skills Experience : Proven track record in technical training or related roles. Leadership : Strong leadership skills to guide a team of trainers and coordinators. Communication : Excellent verbal and written communication. Industry Knowledge : Familiarity with pharmaceutical manufacturing processes. Adaptability : Ability to navigate diverse organizational cultures.

Sun Pharmaceutical Industries Ltd. Position: Senior Manager API Production (Block Head) Grade: G9B Location: API Ahmednagar - Production Planning and scheduling (day to day basis) - Ensuring resources available (BMR, Raw Material Manpower etc.) Liaison with QC/QA/STORE/Eng. Dept. for solving of trouble shooting problem. - Implementation and monitoring of GMP Standard. - Introduction and scale up of technology transfer. (New Prod 1ct) Constantly monitoring and improvement of product process, efficiency, services etc. - Documentation work, Monthly Report, data preparation (Process trend analysis) and root cause analysis. - Ensure the availability of consumable items & Planning of RM require as per campaign basis. - Ensure the documents related to process I cleaning / House Keeping. Control on fresh as well as recovered solvents/ spent solvent. - Ensure the solid and process waste transfer to respective area and record maintaining. - Other activities entrusted from time to time. Review the prepared/ Revision of BMR and SOP. - Operation of electronic system i.e.ONE HR portal, Metis Track wise, Minitab, Out Look etc. - Ensure Preventive Maintenance of Plant Equipment's in time frame. Ensure the training to subordinates. - Extended Facility of reactor Area of Plant-06 production Planning and scheduling (day to day basis)

YOUR TASKS AND RESPONSIBILITIES: Perform site feasibility, identify potential investigator, negotiate study budget with potential investigators, finalization of investigators, sites, and execution of CDA and study-related contracts Preparation and submission of study documents for EC permission for respective study across centers Oversee & document IP dispensing, inventory management & reconciliation Ensure timely site initiation, site monitoring, and site close-out activities are performed and respective reports are generated Investigator and site personnel training on the Study protocol, procedures, and GCP principles Ensure timely recruitment of trial participants and subsequent efficient and effective data entry, source data verification and query resolution Ensure timely reporting of SAEs, SUSARs, and reporting of SAEs to all sites and investigators in alignment with regulations and Suns PV policies Risk identification, analysis, and CAPA for sites not meeting expectations as per the plan Co-ordinate with in-house or CRO partners for data management, statistical analysis, statistical analysis report & DBL WHO YOU ARE: Minimum qualification requirement is to have a Bachelor's or Masters degree in a health[1]related field, such as Biology, Chemistry, Nursing, Pharmacy, or Public Health and/or Post-graduate Diploma in Clinical Research Relevant experience of 1-5 years minimum in the field of Clinical Research Job Locations: Kolkata, Bhubaneswar, Delhi

Maintain the microbiology laboratory as per regulatory requirements. Planning and coordination with cross functional team for timely release of the RM,FP, Stability samples. Handling of microbiology related OOS/OOT, Deviation, Lab event. Prepare the response and closure of audit observations. Change control management for revision of SOP s, Validation protocol. Ensure the availability of resources of microbiology laboratory. Ensure the microbiologist certification program of all microbiologist. Implementation of new projects for cost saving, compliance enhancement , work simplification. Having technical knowledge of following major test MLT of OSD products and MLT validation. Disinfectant efficacy test ( Disinfectant Validation) Maintenance of microbial cultures Maintenance of Microbiological media, Growth promotion test. Autoclave validation LAF, Biosafety cabinet, Incubators, pass box validation. Objectionability assessment of identified inhouse isolates. ALCOA++ Good knowledge of various guidelines like ISO14644, HTM 2010, EU Annex 1, 4, WHO, USP chapter 60, 61, 62, 1115, 1116, 1072, 21 CFR regulations Part 210, 211 Environment monitoring program design, risk evaluation, Location selection, Alert and action limit establishment. Purified water system validation. Chemical and microbial analysis of water. 10. Audit experience for FDA, MHRA. ANVISA, TGA etc. 11. Handling of software following but not limited: SLIMS, Lonza Moda, Equisoft, Vitek 2 compact software, High air flow, ICDAS, Trackwise, EDAMS, LMS, e residue , Lab X software, TOC software 12. Hands on experience of major instruments like: Vitek 2 system, TOC analyser, Autoclave, Conductivity meter, Air sampler, Digital Microscope, LAF, Biosafety cabinet.

1. Purchase of Laboratory Capital & related spares, consumables, services (Opex) etc. for all Sun location. 2. PO Preparation and co-ordination with vendors for timely deliveries. 3. Fortnightly updating pending PR list and keeping track of import clearance. 4. Co-ordination with Accounts dept for resolving payment issue 5. Co-ordination with user for timely GRN so as to achieve OTIF. 6. Co-ordination with Import team for sharing necessary docs and check for import duty benefits. 7. Do market analysis. & utilize business knowledge expertise in day-to-day execution.

Purchase Order Preparation, Verification & Clearance Listing out the Purchasing requestion being generated and Preparation /Submission of Purchase orders for approval. Floating enquiry & arranging quotation/cost break up from Vendor for price comparison. Updating MDM data in system for new item codes. Costing to be done as per our approved costing files. Servicing & Material Availability. Regular follow up with vendors for timely supplies of Packaging materials Ordered. Ensure timely production and dispatches of materials by the vendors. In case of anticipated delay by supplier (due to unavoidable reasons), communicate to Plant team for appropriate action to avoid Production loss. Coordination with Cross functional teams such as Logistics, PDD, Quality & Finance In case of quality issue s in location: Communicate between Site and vendor on the quality complaint and arranging for the samples from the Site for vendor s reference and Investigation purpose followed by satisfactory CAPA for closure of complaints. Coordination with plant & vendor for replacement of materials. Providing the Artwork / Specification & Specimen Sample from PDD / Site QA for developing the New job . Also in case of existing artwork if required. Co-ordinate with QA/PDD for Proof / Shade card approvals. Arranging timely payments to suppliers, by coordinating with Finance team against the material supplied by the supplier. MIS Collation of information for Preparation of Monthly MIS report. Audit : Arranging vendor audit as per requirement of VQ Team. Arranging vendor qualification documents from vendor before and after audit Coordinating with VQ team for audit report and providing compliance from vendor Assisting VQ team for vendor de-registration as and when required. Attending quality issues and providing CAPA to site in coordination with vendor. Projects : Identifying projects for cost saving purpose.

YOUR TASKS AND RESPONSIBILITIES: Perform site feasibility, identify potential investigator, negotiate study budget with potential investigators, finalization of investigators, sites, and execution of CDA and study-related contracts Preparation and submission of study documents for EC permission for respective study across centers Oversee & document IP dispensing, inventory management & reconciliation Ensure timely site initiation, site monitoring, and site close-out activities are performed and respective reports are generated Investigator and site personnel training on the Study protocol, procedures, and GCP principles Ensure timely recruitment of trial participants and subsequent efficient and effective data entry, source data verification and query resolution Ensure timely reporting of SAEs, SUSARs, and reporting of SAEs to all sites and investigators in alignment with regulations and Suns PV policies Risk identification, analysis, and CAPA for sites not meeting expectations as per the plan Co-ordinate with in-house or CRO partners for data management, statistical analysis, statistical analysis report & DBL WHO YOU ARE: Minimum qualification requirement is to have a Bachelor's or Masters degree in a health[1]related field, such as Biology, Chemistry, Nursing, Pharmacy, or Public Health and/or Post-graduate Diploma in Clinical Research Relevant experience of 1-5 years minimum in the field of Clinical Research Job Locations: Mumbai, Pune, Chennai

Experience: 7 to 10 years of product marketing experience Qualification: B. Pharma + MBA - Marketing OR Pharma. Management Therapy/Department: CNS therapy (preferred), we are open to consider candidates from any therapy Industry Preference: Pharma Areas of responsibilities: Development of marketing and promotional plans for products to support the end consumers need Ensuring marketing strategy implementation through sales force connect Market intelligence through primary research and customer connect Collaboration with internal & external media to ensure the proper execution of strategies Providing training, product knowledge, and direction to the field sales team to ensure that they are well-equipped with scientific and communication skills both. To work with cross-functional teams like medical affairs, the learning and development team, and R & D team (Research & Development) in the process. Developing brand plans/strategies for the product range along with market penetration strategy market research and competitor analysis. SWOT analysis of product line (strengths, weakness, opportunities, and threats) and guiding sales team to tap the opportunities and growth in the product sale. Creating brand inputs for promotion like VA, LBL, Newsletter, flipcharts, or digital campaigns like a website or app launch or webinar series, etc. Conducting meetings, scientific symposia, CMEs, and conferences, and ensuring brand visibility in the target audience segment of the pharmaceutical industry, which are healthcare professionals and hospitals. Motivating sales team members by organizing training camps, award ceremonies, and recognition programs. Product forecasting, new product pipeline strategy, new product pre-launch and launch strategy and post-launch, new initiatives for product growth strategy.

Hi, We are having an opening for Manager-IP at our Baroda location. Job Summary : Management of the branded portfolio from IP perspective Areas Of Responsibility : Life Cycle management of branded portfolio from IP perspective Preparation of landscape Preparation of FTO and infringement analysis report Identifying and tracking competition Determining LoE (earliest generic entry) and means to extend it Monitoring applicable regulatory exclusivities Patentability evaluation, patent filing and prosecution Life Cycle management of NCE portfolio Support and Preparation for activities related with enforcement of IP Search and analysis- in NCE, formulation based technologies, Medical Devices related Inventions IP due diligence for technologies and products for in-licensing IP due diligence to support merger and acquisitions IP support for out-licensing projects Agreement review including CDA, IITs, MSA, MTA etc. Performing validity analysis of blocking patents Identifying new opportunities for in-licensing Educational Qualification : M.Pharm (P'ceutical chemistry)/Ph.D in Pharmacy Specific Certification : Certification on patent law- preferred Experience : 8-12 years Skills : Experience on handling: NCE portfolio Patent drafting and Prosecution

Job Title: Manager or Sr. Manager - Compliance Location: Mumbai Summary of Key Responsibilities : We are looking for a candidate at Manager or Sr. Manager level. Responsibilities include providing overall assistance in reviewing sales, marketing and commercial activities to ensure that they are compliant with the company policies and applicable legal, regulatory requirements and also review and monitoring of business activities and document review. Area of Responsibility: Compliance: Supports the business with a view to have all processes and transactions performed in accordance with the organization policies, procedures and applicable legal, regulatory requirements. Provides advice / guidance in the areas of marketing activities of a pharmaceutical company (Interaction with HCPs and HCI s) to the business teams. Support the development of a corporate culture where ethical and compliant values-based behavior is embraced by employees, helps the management to deliver the right tone from the top Support project teams in implementing cross functional ethics and compliance initiatives to include corrective and preventive measures Contribute to the development, review and implementation of the policies, SOP s and guidelines as required on time to time basis. Monitoring/Audit/ Review Review compliance controls for existing processes in business practices and suggest corrective action plans Execute Monitoring/ Review as per Monitoring plan and ensure timely closure. Monitor the performance of Compliance program / activities on a continuous basis. Conduct periodic reviews of documentation and transaction audits and remedial action measures. Ensure proper documentation before commencement of activities and proof of closure Maintenance of documentation/ record of Monitoring activities Partner with relevant departments to follow up with respective functions for mitigation plan execution and ensure implementation of corrective actions Prepare / Assist with p periodic reports and data analysis to /for relevant stakeholders Training/Awareness : Create awareness and conduct knowledge sharing sessions, training on compliance related topics and maintain records in relation thereto. Train / Mentor Business Compliance Executives / Analysts on Job Position requires national travel Qualification: Atleast 10 years of total previous work experience minimum 5+ years of relevant experience in compliance or legal Preference in Pharmaceutical Industry Familiarity with UCPMP and Local Pharmaceutical related laws and regulations in India

Job Title: Senior Executive Job Grade: G11B Department: NAM Quality Cluster Location: Vadodara Job Summary This position shall be responsible for Preparation of quarterly report to be sent to FDA for CD copies sent to vendors and employees. Management of new material codes creation in MDO Fuse portal for Quality and R&D functions. Management of GMP consultants travel arrangement for visiting Sun Pharma India sites, including review/verification and payment processing of consultants invoices. Area Of Responsibility Prepare quarterly report to be sent to FDA for CD copies sent to vendors and employees. Creation of new material codes creation for ZLAB items in MDO Fuse portal for Quality and R&D functions. Management of GMP consultants travel arrangement for visiting Sun Pharma India sites, including review/verification and timely payment processing of consultant’s invoices. Coordinate with site for site review of GMP consultant’s invoices and get site and Global Quality and Compliance Head approvals for the same Coordinate with commercial/finance team for preparation of PR/PO/GRN for the consultants’ invoices and timely payment processing. New Material codes creation management for ZLAB items in MDO Fuse portal for Quality and R&D functions. Any additional work assigned by the reporting manager to support North America Cluster. Work Conditions: Corporate Office Environment Travel Estimate Up to 10 % Education and Job Qualification A minimum of a Master’s degree in Commerce or relevant scientific field is required. A minimum of 8+ years of experience in a pharmaceutical industry with good exposure in Procurement/Finance/Quality is required. Strong knowledge of commerce, import/export management is essential. Good organizational, interpersonal and communication skills are essential. Excellent interpersonal skills and ability to communicate effectively with middle management levels of the organization and external stakeholders Expertise in software applications such as: MS Word, MS Excel, MS Office, Windows, PowerPoint, Microsoft Outlook, Code Creation, SAP-HANA etc. Experience A minimum of 8+ years of experience in a pharmaceutical industry with good exposure in Procurement/Finance/ Quality is required. Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).

Position: Manager Investigation Lead (OSD) Function: Production Sub-function: Lead Investigation of UPD/OOS/OOT Location: Halol-II Tablet Department Areas of Responsibility JOB DESCRIPTION: He is accountable for COE (Centre of Excellence) related activities. He is accountable for daily activity (as a Manager) : Overall responsible for production and packing activities related to Tablet, Soft Shell &Gel department. Responsible for the day to day production functions in production. Establishing new procedures, maintaining and updating existing procedures in the Tablet, Soft Shell& Gel department. To assist establishing a system in accordance with Good Manufacturing Practice guidelines and Responsible for follow established procedures, maintaining and updating existing procedures department. Updation Approval and Execution of BMR, SOP, Protocol and other GMP documents. Preparation of daily reports to production manager / superiors on day to day activities concerning the department. Coordination with other departments like Administration, Warehouse, Quality Control, Quality Assurance, Quality Engineering, MIS and Engineering for related activities. Responsible to co-maintain, coordinate for validation and GMP in all departments along with the Quality Assurance officer and to co- ordinate with Quality control department in matters relating to product quality. Train the subordinates and manpower to meet the organizational goals and achieve GMP compliance. Optimization of resources namely men, material and machine in respective department. Help the officers/ subordinates into standardize production activities to achieve better efficiency and product quality. Responsible for Calibration, Qualification and Validation activity of respective Equipments or Product. Responsible for Production Planning, schedule, control and execution, E-log / Ample Logic Execution. Approval of Job Responsibility & Indent. Responsible for investigation preparation and approval in trackwise. Initiator, Review & approval in Track wise, Medhas Module, EDMS, SAP, LMS module access. Responsible to perform the internal audit as auditor. Responsible for preparation / review of Risk assessment for New / Existing product, Evaluation and Approval. Responsible for Activity of Rejection / Reprocessing based on Corrective actions of Investigation. Destruction note review and approval. Responsible for Effective Compliance of Regulatory Observation, its Report documentation & Approval. Procurement of machineries, change parts, spares and material required in respective department. Any other job assigned by the superior. Also responsible for carrying out any other responsibilities assigned by superior from time to time orally or in writing. Educational Qualification : B Pharmacy/M Pharmacy Skills : Good Writing Skill on UPD/OOS/OOT Experience : 15 to 18 Yrs

Responsibilities Responsible for Downstream activities in Bulk Manufacturing/production facility. Role: 1. Ensure Facility monitoring, readiness, maintenance, equipment operations like Mixing vessels, TFF systems, AKTA systems, buffer preparation, chromatography techniques, autoclave operations, and coming in shifts basis for involving & supporting in continuous manufacturing of biological products at Bulk Manufacturing (BM) /production facility. 2. Operate the Autoclave and DHS activities 3. Tracking of inventory of process raw materials & consumables used in manufacturing. 4. To understand and follow the safety practices and usage of PPEs in Bulk Manufacturing facility and during process. 5. Execution of Scale up of Development batches in Bulk Manufacturing facility with coordination of R&D support. 6. Coordination with engineering department and external vendor on tracking and completion of preventive maintenance/calibrations activities of Downstream process Equipment and instruments. 7. Follow good documentation practices (GDP) such as online documentation and ensuring cGMP compliance in downstream process and facility operations. 8. Coordination with stake holders and Involve in technical trainings, safety trainings related activities for smooth functioning in production facility.

Role & responsibilities :- Job Summary : Regulatory submission of new products, variations, response to queries, Life cycle management for US and OAM region through preparation of quality dossiers enabling timely approvals. Area Of Responsibility 1. New submissions: a. Review & prepare CMC (Chemistry, Manufacturing and Controls) dossiers for fresh submissions. b. Review documents (Development report, scale up report, specification, stability protocol, analytical validation), etc. Before initiation of Exhibit batches for adequacy. 2. Approval : Review & prepare response to deficiency enabling approval of products filed to regulatory agency. 3. Lifecycle management for drug formulations : a. Prepare and review variation , Annual notification and labelling approval for US and OAM b. Review of change control and file variation as per country requirement 4. Regulatory compliance: a. eCTD compilation b. Ensure reposition of comprehensive product information into central repository C. Review regulatory filing impact of variations, change controls, etc