IND
106 days ago
Senior Manager - Projects (Process Equipment)
**Position:** Senior Manager - Projects (Process Equipment) **Job Title:** Senior Manager - Projects (Process Equipment) **Job Grade:** **(G9B- Sr. Manager)** **Function:** PROJECTS **Sub-function:** **Managers Job Title:** **Skip Level Managers Title:** **Function Head Title:** **Location:** Central or South India (Greenfield Project) **No. of Direct Reports (if any)** **Job Summary** He will lead Installation commissioning of Ophthalmic and Injectable facility Process equipments. He is responsible for timely completion of project as per defined quality and cost. **Areas of Responsibility** 1. To handle manufacturing and component washing and sterilization area. 2. To handle process like manufacturing of liquid product including media, complex injectable and suspension manufacturing. 3. To handle the process equipments in manufacturing like manufacturing skid, filtration skid, suspension manufacturing skid, CIP SIP skid for manufacturing and filtration equipments, dispensing isolators, manufacturing isolators, pH meter, DO meter, integrity tester etc. 4. To handle component washing and sterilization area and its equipments like Autoclave, Terminal sterilizer, ultrasonication machine, GMP washer, VHP pass box, external washing machine, leak test and X ray inspection machine etc. 5. To handle indenting to procurement of new manufacturing equipments as well as component washing and sterilization equipments as mentioned above. 6. To ensure compliance to cGMP and documentation for various production activities 7. Experience for preparation and execution of qualification protocol of new equipment like, User requirement specification, Design qualification, Installation qualification, operational qualification and performance qualification. 8. To prepare of new standard operating procedure for process and equipments. 9. Experience for preparation of batch manufacturing records. 10. To handle the QMS documents like change control, CAPA, risk assessment, deviation etc. 11. To handle communication with vendor and procurement team on procurement to design parts of new equipments 12. Ensure proper planning and execution of the qualification activity in accordance with the plan and allocation of man power. **Travel Estimate** **Medium** **Job Scope** **Internal Interactions (within the organization)** Check in Internal as well as External both **External Interactions (outside the organization)** Check in Internal as well as External both **Geographical Scope** **Financial Accountability (cost/revenue with exclusive authority)** **Job Requirements** **Educational Qualification** B. Pharmacy, M. Pharmacy **Specific Certification** **Skills** **Technical Skills/Competencies (Software packages, experience with specific machines etc.)** AutoCAD, MS Office, MS Projects, Primavera. Excellent communication skills, strong collaborator, problem solving, interdepartmental coordination, team leadership. **Experience** (12to 15 Years of experience in relevant field in Pharmaceutical Industry.) **Age 27 to 32 years.** **_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)._ We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.
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