Team Member Qualification

Company DescriptionDr Reddys Laboratories Ltd is a leading multinational pharmaceutical company based across global locations Each of our 24 000 plus employees comes to work every day for one collective purpose to accelerate access to affordable and innovative medicines because Good Health Cant Wait We started in 1984 with a modest investment 20 employees and a bold vision Today we have research and development centres manufacturing facilities or a commercial presence in 66 countries For nearly four decades we have stood for access affordability and innovation based on the bedrock of deep science progressive people practices and robust corporate governance As the pharmaceutical industry evolves and undergoes disruption we see an opportunity to strengthen our core further the next steps and to build the future the new bets xe2x80x98The Next and the New is how we aim to continue to be the partner of choice purpose-driven future-ready and sustainable Our aim is to reach over 1 5 Bn patients across the world by 2030 by growing our core businesses and building for the future with sustainability at the core of our purpose and strategy Sustainability for us means operating in a manner that respects people planet and purpose helping us conserve precious resources serve our patients create value for stakeholders give back to society fulfil our potential and maintain our integrity and transparencyDr Reddys maintains a work environment free from discrimination and is an equal opportunity employer We are committed to employ nurture all qualified diverse workforce without regard to race colour religion nationality sex age disability status genetics sexual orientation gender expression citizenship or any other characteristic or classification protected by applicable law s of the country we operate in We treasure every talent and recognize merit and diversity in our organization Job Summary We are looking for an individual for the qualification team to manage the documentation and execution of qualification activities including the preparation review and execution of various qualification documents The ideal candidate will oversee new project-related tests review and compile raw data and ensure compliance with validation master plans and SOPs Additionally responsibilities include implementing corrective and preventive actions conducting incident investigations and providing support during regulatory inspections Roles Responsibilities You will be responsible for documentation and execution of qualification activities This includes preparation review and execution of URS User Requirement Specification DQ Design Qualification FDS Functional Design Specification UTM User Traceability Matrix IQ Installation Qualification OQ Operational Qualification PQ Performance Qualification RQ and Requirement Qualification documents Your responsibilities include review of miscellaneous qualification documents and preparation and review of risk assessments for equipment and systems You will be responsible for new project related FAT Factory Acceptance Test and SAT Site Acceptance Test You will review and compile raw data relevant certificates analysis test reports and preparation and review of final summary report You will be responsible for preparation and review of protocols and reports for media fill validation and cleaning validation Your role involves initiation of relevant CRN Change Request Number for new or existing activity timely closure of assigned action plans as per CRN and CRN review and approval You will be responsible for corrective and Preventive Action CAPA implementation and handling of incident investigations and CAPA related to qualification As part of your role you will prepare and review VMP Validation Master Plan You will conduct training for employees and external vendors as a qualified trainer Your role includes preparation and review of qualification SOPs Standard Operating Procedure conducting investigations as a site investigation team member and updating Qualification status label You will be responsible for periodic qualification schedule preparation updating and execution and qualification of new or transferred equipment You will also provide necessary assistance and support to various regulatory internal and external inspections QualificationsEducational qualification B Pharm M Pharm B Tech M TechMinimum work experience 5 to 8 years of experienceSkills attributes Technical Skills Experience in working with sterile product facility related equipment qualifications such as Isolators Autoclave vessel Skids etc and validations such as media fill cleaning validation process validation area qualification and other miscellaneous qualifications Expertise in preparation review and execution of documents including URS DQ FDS UTM IQ OQ PQ RQ Experience in Handling incident investigations and CAPA processes Experience in preparation and review of VMP and SOPs Behavioural Skills Effective communication skills for conducting training sessions and qualification activities Attention to detail for preparing and reviewing documentation and reporting Application of problem-solving skills in incident investigations and CAPA implementation Efficient time management for meeting qualification schedules Additional InformationAbout 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 xe2x80x98factories of the future is integral to innovation and to build healthcare of the future Benefits Offered At Dr Reddys we actively help to catalyse your career growth and professional development through personalised learning programs The benefits you will enjoy at Dr Reddys 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 Reddys why they come to work every day and theyll say because Good Health Cant 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 were 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