377 Osd Jobs - Page 15

Roles and Responsibilities Ensure compliance with GMP guidelines, BMRs, OSD requirements, and WHO standards for IPQA activities. Develop and implement effective quality control processes to ensure product quality and regulatory compliance. Conduct regular audits, inspections, and investigations to identify areas of improvement in batch manufacturing operations. Collaborate with cross-functional teams to resolve quality issues related to formulations, tablets, capsules, etc. Provide training on Good Manufacturing Practices (GMP) and other relevant regulations to employees.

Job Summary We are seeking an associate for the Quality team responsible for conducting sampling and analysis of packaging and raw material samples. The role involves ensuring accuracy in documentation, adherence to safety procedures, reporting discrepancies, and maintaining lab safety. Roles & Responsibilities • You will be responsible for conducting sampling and analysis of raw material samples as allotted by the group leader. • You will also be responsible for the proper use and care of instruments or equipment as instructed in relevant SOPs (Standard Operating Procedure), including cleaning before and after analysis. • You will adhere to safety precautions and procedures during analysis. • Your responsibilities include placing SOP/STP/reference standards at their designated locations after analysis, and reporting discrepancies or incidents promptly to the Group Leader. • Lab safety, following JSA (Job Safety Analysis), and using proper PPE (Personal Protection Equipment) at the workplace are emphasized. • You will oversee the handling and upkeep of the chemical and solvent store, preparation of Spec-check, catalog, and result entries, as well as maintaining volumetric solutions and reagents. • Your role also includes preparation of out lab testing samples (as required), timely destruction of samples as per SOP and any additional responsibilities assigned by the Group Leader. Qualification Educational qualification: A Bachelor’s degree in Chemistry, Analytical Chemistry, or a related field Minimum work experience : 2 to 5 years of experience in a laboratory setting, preferably in the pharmaceutical or related industry Skills & attributes: Technical Skills • Proficient in various analytical techniques, including sampling and analysis of raw material samples. • Experience with the operation and maintenance of analytical instruments like HPLC, GC, Potentiometer, Particle Size Analyzer, XRD, ensuring proper use and care as per SOPs. • Competent in LIMS activities related to sample tracking, documentation, and data entry. • Knowledgeable about cGMP, SOPs, and STPs, ensuring accurate documentation and adherence to specifications. • Adheres to safety precautions and procedures during analysis, emphasizing the importance of lab safety, JSA (Job Safety Analysis), and proper use of PPE (Personal Protective Equipment). • Expertise in handling and upkeep of the chemical and solvent store, including the preparation and maintenance of volumetric solutions and reagents. Behavioural Skills • Keen attention to detail in analysis and documentation, ensuring accuracy in all tasks. • Effective communication and collaboration skills for communicating with the Group Leader, reporting discrepancies, incidents, and providing timely updates. • Takes initiative in ensuring the proper use and care of instruments, timely destruction of samples, and other assigned responsibilities. • Demonstrates problem-solving skills in addressing discrepancies, incidents, and ensuring smooth laboratory operations. • Upholds ethical standards, compliance with SOPs, and follows regulatory requirements in all activities. Additional Information About the Department Global Manufacturing Organisation (GMO) At Dr. Reddy's Laboratories, we are dedicated to making a meaningful impact on global healthcare through precision manufacturing and innovation. With a legacy of excellence, we are a leading force in the pharmaceutical industry. We operate 19 state-of-the-art manufacturing plants across Hyderabad, Vizag, Baddi, Mexico, Shreveport, and Mirfield, comprising 8 OSD facilities, 3 Injectables facilities, and 8 API facilities. Benchmarking manufacturing processes and continuous operational excellence are at the core of our capability to deliver quality medicines to our patients in 66 countries. We manufacture a portfolio of complex APIs and 1,150+ drug master files across key therapy areas such as Oncology, Cardio-vascular, Central Nervous System and Anti-Diabetes. he World Economic Forum has recognised our largest manufacturing facility in Bachupally, Hyderabad, as part of its Global Lighthouse Network. We aspire to be the most efficient pharma operations in the world. Our productivity improvement and digitalisation efforts are key to staying competitive, meeting business imperatives, and meeting our ambitious ESG goals. Building such ‘factories of the future’ is integral to innovation and to build healthcare of the future. Benefits Offered At Dr. Reddy’s we actively help to catalyse your career growth and professional development through personalised learning programs. The benefits you will enjoy at Dr. Reddy’s are on par with the best industry standards. They include, among other things and other essential equipment, joining & relocation support, family support (Maternity & Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, life coverage for yourself. Our Work Culture Ask any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we’re always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic. For more details, please visit our career website at https://careers.drreddys.com/#!/

- Develop analytical methods for OSD products using techniques such as UV, FTIR, Dissolution, HPLC, GC, Ion Chromatography, Wet Analysis etc. - Conduct method validation studies to ensure compliance with regulatory requirements. - Collaborate with cross-functional teams to resolve method-related issues and improve process efficiency. - Ensure timely completion of tasks assigned by supervisors while maintaining high-quality standards.

Roles and Responsibilities - Operate auto cartonator machine to produce high-quality packaging materials. - Ensure accurate cutting, folding, and gluing of cartons according to specifications. - Maintain a clean and organized work area to prevent waste and optimize production efficiency. - Collaborate with team members to troubleshoot issues and improve overall performance. - Conduct regular quality checks on produced cartons to ensure compliance cGMP standards. Qualification: ITI Certification

Roles and Responsibilities - Ensure quality control processes are followed by the team. - Conduct regular inspections to identify areas for improvement. - Develop and implement quality standards, procedures, and documentation. - Collaborate with cross-functional teams to resolve quality issues. - Analyze data to track trends and improve overall product quality.

Roles and Responsibilities - Operate blister packing machines to package pharmaceutical products in blisters. - Ensure accurate and efficient packaging of tablets, capsules, or other solid dosage forms. - Maintain a clean and organized work environment to meet quality standards. - Troubleshoot machine issues and perform routine maintenance tasks as needed. - Collaborate with team members to achieve production targets. Qualification: ITI certification

Walk-in at Matoda We are hiring multiple positions for our manufacturing facility at Matoda as mentioned below. Please find our current job requirements and venue details mentioned. If any of the requirements match your current job profile, kindly walk in with your latest resume. Role & responsibilities QUALITY ASSURANCE IPQA (Injectable), IPQA (OSD) & QMS / Documentation / Validation and Qualification (Officer / Senior Officer / Executive/Senior Executive) Experience - 02 to 09 Years Qualification - B. Pharmacy/ M Pharmacy / M.Sc. Injectable Manufacturing Aseptic operations/ QMS / SKID / Multi-vessel / SVP / Visual Inspector (Senior Officer / Officer / Associate) Experience - 01 to 05 Years Qualification - B. Pharmacy/ M Pharmacy / Msc /Bsc / Diploma / ITI OSD Manufacturing / Dispensing / QMS (Senior Officer / Officer / Associate) Experience - 01 to 05 Years Qualification B Sc / M Sc / B. Pharmacy/ M Pharmacy / Diploma Time and Venue : 17th May 2025, 09:30 Hrs to 14:00 Hrs SATURDAY ______________________________________________________ INTAS, Matoda facility Plot No. 457, 458 Sarkhej Bavla Highway, Matoda Village, Sanand, Taluka, Ahmedabad, Gujarat 382210 ______________________________________________________ We would be pleased if you forward or refer any of your colleagues matching the desired job roles. Preferred candidate profile *Having relevant qualification as mentioned above can attend the scheduled walk-in.

Excellent Opportunity! Analysts required in the QC department at Unison Pharmaceuticals Pvt Ltd, Moraiya. Apply Now!!! Company: Unison Pharmaceuticals Pvt Ltd Experience: 1-8 Years Qualification: B.Pharma/M.sc/M. Pharma Location: Moriya, Ahmedabad Job Role : Physico Chemical (Analyst)- Friability / DT / Hardness / Thickness / UV Perform physical and chemical analysis for Raw material/ Inprocess / Finished Product based on the test requirements like UV, friability, DT, hardness, thickness, moisture, average weight, and uniformity weight. Prepare documents for each analysis performed and get those checked by the reviewer. Perks & Benefits Dynamic work environment Career development opportunities Work-life balance Free transportation Canteen Facility Free insurance coverage for self, spouse, and kids Range of learning opportunities to help employees grow and thrive If you are passionate about continuing to work in the pharmaceutical industry and possess the required skills, we encourage you to apply for this position. Please submit your resume to career@unisonpharmaceuticals.com to be considered for this role. Join our team at Unison Pharmaceuticals and take the first step towards a rewarding career!!! Regards Team HR Unison Pharmaceuticals Pvt. Ltd.

Key Accountabilities Process/ Operational: 1. Basic knowledge for Review of Pharmaceutical Development Report. 2. Basic knowledge / hands on experience of review of manufacturing documents like batch formula, batch manufacturing records, batch packaging records, yield and reconciliation, manufacturing summaries, in-process controls data, etc. 3. Basic knowledge / hands on experience of review of analytical documents like specifications, test procedures, method equivalency reports, method validation/verification reports and method transfer reports, dissolution protocols, stability protocols, extractable & leachable study reports, etc. 4. Basic knowledge / hands on experience for preparation, review and compilation of assigned ANDAs for submission. 5. Basic knowledge / hands on experience for preparation, review and compilation of Annual Reports (ANDAs/NDAs). Strategic: 1. Basic knowledge of ICH guidelines, FDA guidelines. 2. Knowledge of CTD modules 1,2 and 3.

Good understanding on formulation & Development for regulated market/Should have experience on product technology transfer at plant side/ Knowledge on QBD,Good documentation practice/literature survey/ICH guidelines/ Solid Oral/Injectables/ OSD Required Candidate profile Execution of process evaluation, optimization, scale-up and exhibit batches. Meeting product development timelines/ Solid Oral/ Injectable Candidate can share their CV on stuti.naik@enaltec.com

Project Role : Infra Tech Support Practitioner Project Role Description : Provide ongoing technical support and maintenance of production and development systems and software products (both remote and onsite) and for configured services running on various platforms (operating within a defined operating model and processes). Provide hardware/software support and implement technology at the operating system-level across all server and network areas, and for particular software solutions/vendors/brands. Work includes L1 and L2/ basic and intermediate level troubleshooting. Must have skills : Microsoft Intune Good to have skills : NA Minimum 5 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As an Infra Tech Support Practitioner, you will be responsible for providing ongoing technical support and maintenance of production and development systems and software products, both remote and onsite. You will work on various platforms, implementing technology at the operating system-level and performing basic and intermediate level troubleshooting tasks. Roles & Responsibilities: Expected to be an SME Collaborate and manage the team to perform Responsible for team decisions Engage with multiple teams and contribute on key decisions Provide solutions to problems for their immediate team and across multiple teams Implement technology at the operating system-level Perform hardware/software support Troubleshoot at L1 and L2 levels Professional & Technical Skills: Must To Have Skills: Proficiency in Microsoft Intune Strong understanding of IT operations Experience with server and network areas Knowledge of software solutions/vendors/brands Hands-on troubleshooting experience Additional Information: The candidate should have a minimum of 5 years of experience in Microsoft Intune This position is based at our Bengaluru office A 15 years full time education is required

Role & responsibilities : 1 To perform Operation activity of equipment and instruments as per SOP. 2. To affix the status label to equipments, instruments and IPC at each and every processing stage 3. To operate the equipment in safe and effective manner for production processing. 4. To follow and adhere to GDP and cGMP practices. 5.Inspect equipment to identify any replacement, and repairs. 6. Ensure that the equipment are maintained in good and safe working condition. 7. To Perform regular equipment maintenance to ensure production capacity and quality. 8. Identify and report unsafe operations and near misses to supervisor immediately. 9. Perform the activity as per SOP and instruction given in BMR and BPR. 10. To perform balance Calibration and instrument calibration as per SOP Preferred candidate profile: 1. 02- 06 years of experience in Formulation Pharmaceutical Plant. 2. Relevant Experience in Pharma formulation plant. 3. Computer proficiency in MS Office, Excel, e-mail and internet function.

Responsible for performing the analytical activities as per Analytical competency matrix (Format No.BDI-QCSG004F23) and On job training and Practical Demonstration for Chemical and Instrumentation (Format No.BDI-QCSG004F19). Analysis of In process, SFG, Finished Goods, Raw material & stability sample, Analytical method validation/Verification, of OSD and LVP as per defined Protocol or procedure and related documentation as per GLP and GMP in time. Responsible for receiving sample and their documentation. Responsible Data entry in SAP. Responsible for sending the sample to outside laboratory and ensure their analysis as per requirement from Outside Commercial Lab as and when required. Calibration of instruments, as and when required. Preparation of volumetric solution, reagent, and test solution, as and when required. Ensuring the timely updation in the documents as per the Pharmacopeial amendments. Responsible for maintaining the resource in the quality control department. To ensure the compliance of the requirement of cGDP/cGDP and Data integrity while performing all activities in the laboratory. Ensuring the Compliance to EPD Global Guidelines. Facing internal and external audits and ensuring compliance. Implementation of GLP / GMP requirements. Coordinating and aligning the practices and procedures in line with the COBC requirements. SOP training in Isotrain of self-train within stipulated time.

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.

Role & responsibilities Candidate having experience in to OSD pharmaceuticals from QC/QA/Production/F&D/ADL

Project Role : Application Developer Project Role Description : Design, build and configure applications to meet business process and application requirements. Must have skills : SAP Document and Reporting Compliance Good to have skills : NA Minimum 5 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As an Application Developer, you will be responsible for designing, building, and configuring applications to meet business process and application requirements. You will collaborate with teams to ensure successful project delivery and implementation. Roles & Responsibilities: Expected to be an SME Collaborate and manage the team to perform Responsible for team decisions Engage with multiple teams and contribute on key decisions Provide solutions to problems for their immediate team and across multiple teams Lead and mentor junior professionals Conduct regular team meetings to discuss progress and challenges Stay updated on industry trends and best practices Professional & Technical Skills: Must To Have Skills: Proficiency in SAP Document and Reporting Compliance Strong understanding of SAP data structures and reporting functionalities Experience in SAP implementation projects Knowledge of SAP security and compliance standards Hands-on experience in SAP configuration and customization Additional Information: The candidate should have a minimum of 5 years of experience in SAP Document and Reporting Compliance This position is based at our Bengaluru office A 15 years full-time education is required Qualification 15 years full time education

Role & responsibilities Analytical Method development of solid oral dosage form/Semisolid/Liquid and other dosage form. Analytical Method validation of above dosage forms. CDP study: Protocol and report preparation of validation. SOP and Specs Preparation. Preferred candidate profile Minimum 4 years of experience in Analytical development laboratory MSc- Chemistry Preferred Perks and benefits Company Travel

Role & responsibilities We are seeking a diligent and experienced QA & QC & production. The successful candidate will Ensure that our products meet specified quality standards. This role involves managing both Quality Assurance ( QA ) and Quality Control (QC) processes, conducting inspections, and implementing improvements to maintain and enhance product quality. Expanding role in building a team of QA/QC executives. Salary Range: 15,000 to 25,000 (negotiable based on experience & skills) Experience: Minimum 2 years in QA/QC department of Tablet & Capsule or pharma manufacturing unit Preferred candidate profile Quality control analyst Responsible for testing and analyzing pharmaceutical products to ensure they meet established quality standards. They work in laboratories, using analytical Techniques to test raw materials, in-process samples, and finished products. Quality assurance analyst Responsible for ensuring compliance with regulatory requirements by conducting audits, inspections, and assessments Preferred candidate profile Qualification B.Pharma , B.Sc or B.Tech Biotech D.Pharma DIKSHA ( 8628944666 ) (9:30 AM to 7:30 PM ) Preferred candidate profile Company - Top Pharmaceuticals Companies based at Baddi HP. Fresher & Experience. Job Location- Chanigarh,Panchkula, Paonta Sahib ,BADDI ( Himachal Pradesh ) Functional : QC,QA & Production.Industry: Pharma manufacturing unit/ Food Technology The Saksham Success Enterprises Near Sunder Ayan by pass solan 173212 Himachal Pradesh Contact us DIKSHA ( 8628944666 ) (9:30 AM to 7:30 PM )

Role & responsibilities 1. Production Planning and Scheduling 2. Compliance and Documentation 3. Supervision of Manufacturing Processes 4. Personnel Management and Training 5. Quality and In-Process Control 7. Process Optimization and Yield Improvement 8. Regulatory and Customer Audits Preferred candidate profile Education: B.Pharm / M.Pharm / B.Sc with strong domain knowledge in OSD manufacturing. Experience: 15+ years in pharmaceutical production, with at least 5 years in a managerial role overseeing OSD manufacturing. Regulatory Exposure: Hands-on experience in facing WHO-GMP, and other inspections. Skills: Leadership, decision-making, analytical thinking, team management, and strong knowledge of GMP and QMS.

Role & responsibilities 1. Packaging Development activities for primary, secondary & tertiary packs for Domestic, Regulated & Non-Regulated market as per marketing/Regulatory/customer requirement. 2. Monitor & control the Artwork development and approvals. 3. Getting changes made in artworks from as per marketing, Regulatory & customer requirements. 4. Preparing Master Packing Specification, Material Specification & Approved Vendor List 5. New & Periodic Vendor Audits for packing material. 6. Shade approval & shade card management. 7. Interdepartmental & vendor co-ordination & follow ups. 8. Handling packing material complaints.

Role & responsibilities Conduct in-process checks during various stages of sterile injectable manufacturing, including dispensing, compounding, filtration, filling, and sealing. Perform line clearance and area clearance before the start of manufacturing and packaging operations. Monitor aseptic practices and personnel hygiene compliance inside cleanrooms and controlled areas. Verify critical process parameters and environmental conditions during batch processing. Ensure compliance with SOPs, batch manufacturing records (BMR), and batch packaging records (BPR). Participate in visual inspection activities and oversee container-closure integrity checks. Monitor the usage and replacement of sterilized garments, materials, and equipment in aseptic areas. Raise deviations, non-conformances, and change controls as needed. Assist in investigations for OOS, OOT, or any batch-related quality issues. Provide training to operators and workers on GMP, GDP, and aseptic technique

Role Summary: OSD Production QMS is responsible for ensuring adherence to quality standards within the production process. The role involves monitoring production activities, implementing quality control measures, maintaining compliance with regulatory requirements, and driving continuous improvement initiatives. Roles And Responsibilities Quality Compliance: Implement and monitor compliance with QMS standards Industry-specific standards. Conduct periodic audits of production processes to identify deviations and enforce corrective actions. Ensure all production processes align with regulatory and company quality standards. Documentation & Reporting: Maintain and update standard operating procedures (SOPs), work instructions, and quality records. Prepare detailed reports on quality performance, including non-conformance incidents and corrective actions taken. Process Improvement: Analyze production workflows and recommend improvements to enhance efficiency and quality. Participate in root cause analysis for production issues and implement preventive measures. Key Skills and Competencies: In-depth knowledge of Quality Management Systems and standards. Strong analytical and problem-solving skills. Excellent communication and interpersonal abilities. Proficiency in using quality management tools and techniques. Familiarity with relevant USFD, EU, TGA regulatory requirements and industry best practices.

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.

Roles and Responsibilities Prepare dossiers for regulatory submissions (ANDA) according to US FDA guidelines. Manage CMC sections of ANDA applications, including formulations and OSD products. Coordinate with cross-functional teams for dossier preparation and submission. Ensure compliance with regulatory requirements throughout product lifecycle management. Maintain accurate records and databases related to regulatory affairs activities.

Roles and Responsibilities 1. Review of Technology data package and preparation of Gap analysis document. 2. Preparation of technology transfer protocol and report. 3. Co-ordination with FD for smooth Tech Transfer. 4. Monitoring of validation batches at production site. 5. Perform Feasibility trials, Product evaluation trials to understand critical process parameter for smooth transfer and process understanding. 6. Review of MPCR and protocol. 7. Planning for Execution of Process design, Process qualification batch. 8. Coordination with Production, Quality assurance, Quality control, Engineering, Regulatory Affairs, SCM and warehouse for the TT activities. 9. Should be part of handling deviation, change control and failure investigations. 10. Process manufacturing parameters for Qualification batches Vs Commercial batches. 11. Preparation and reviewing of intended batch documents for regulatory submission. 12. Trouble shooting of existing products and process improvement to increase output or to reduce processing time or to improve the quality of products.