Qe- Manager

Job Title Projects Engineering - QE Business Unit Sun Global Operations Job Grade G10 - Manager 1 Location New green field site Pithampur - Indore At Sun Pharma we commit to helping you Create your own sunshine - by fostering an environment where you grow at every step take charge of your journey and thrive in a supportive community Are You Ready to Create Your Own Sunshine As you enter the Sun Pharma world you ll find yourself becoming Better every day through continuous progress Exhibit self-drive as you Take charge and lead with confidence Additionally demonstrate a collaborative spirit knowing that we Thrive together and support each other s journeys Key responsibilities Expertise in qualification of below process and equipment s To aware about the process like vial washing depyrogenation filtration filling manufacturing lyophilizer component washing and sterilization terminal sterilization isolators CIP SIP skid leak test X ray inspection VHP clean utility like steam compressed air PW and WFI generation system AHU FFM To handle the designing and qualification activity of process equipment s like vial washing tunnel sterilizer filling machine capping machine Lyophilizer loading and unloading system Lyophilizer filtration skid and isolators VHP passbox manufacturing skid suspension manufacturing skid CIP SIP skid for manufacturing and filtration equipment s dispensing isolators manufacturing isolators pH meter DO meter integrity tester Autoclave Terminal sterilizer ultrasonication machine GMP washer external washing machine leak test and X ray inspection machine packing equipment s etc To handle the designing and qualification activity of Utility like Pure steam generation and distribution system Purified water and WFI generation and distribution system Nitrogen and compressed air generation and distribution system AHU FFM LAF area cold storage etc To handle indenting to procurement of accessories and equipment s required for qualification activity of above equipment s and area To handle preparation review and execution of qualification protocol of new equipment like User requirement specification Design qualification Installation qualification operational qualification performance qualification and Computer system validation and qualification To prepare schedule for qualification activity calibration activity updation of status label of qualification activity etc To prepare and execution of schedule requalification protocol of equipment s and utility To prepare new standard operating procedure for qualification activity and also review SOP of process equipment s To handle the QMS documents like change control CAPA risk assessment deviation etc To handle communication with vendor and procurement team on design parts of new equipment s To ensure compliance to cGMP and documentation for various qualification activities Issuance retrieval and storage of qualification documents Ensure proper planning and execution of the qualification activity in accordance with the plan and allocation of man power Exposure of regulatory auditors like USFDA EU ANVISA CANADA etc Travel Estimate As required Job Requirements Educational Qualification B Pharmacy M Pharmacy Experience Tenure 5 to 10 Y Years of experience in relevant field in Pharmaceutical Industry Your Success Matters to Us At Sun Pharma your success and well-being are our top priorities We provide robust benefits and opportunities to foster personal and professional growth Join us at Sun Pharma where every day is an opportunity to grow collaborate and make a lasting impact Let s create a brighter future together 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