Manager - 2

Job Title:

Sterile QMS In charge    

Business Unit:

Sun Global Operations

Job Grade

Manager

Location :

Dewas

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.”

Responsibilities:

• To ensure contamination control are available and followed at site as per Contamination Control Strategy (CCS) and respective procedures.
• Handling of QMS activities (OOT / OOS / Market complaint / Investigation / CAPA / deviation & change control).
• Implementation of site and global CAPA w.r.t. Block-P.
• To prepare audit (Self Inspection/Customer/External Inspection/Regulatory) observation response.
• To review & approve all the documents related to validation like protocols/reports etc.
• To explain the process and documents to auditors during the audits and implement the recommendation of internal/external/regulatory audits outcome and ensure audit compliance.
• To review & approve the SOPs, specifications, packing instruction relating to production & ensures their implementation.
• To ensure timely completion of validation/qualification activities for aseptic process simulation (Media Fill), equipment’s & systems as per approved procedure.
• To plan the packing activities of the department as per weekly / monthly delivery schedule.
• To meet the production schedule both in quantity & quality.
• To ensure the hygiene & maintenance of packing department, system & equipment are in neat & tidy condition at all time.
• To do counselling & grievance handling of the subordinates of packing section.
• To ensure that the finished products are produced & stored according to appropriate documentation & meet timely deliveries as per production schedule.
• To review the Batch Production Record / POPI & FOMI.
• To ensure completion of SAP Transaction on time.
• To review & approve for Master Batch Packing/Manufacturing Record.
• To perform in process checks & record in log books & PI / MI.
• Issuance of material from block store to process area as per P.O. / F.O and updates the stocks in SAP.
• To ensure online recording data and complete the documentation on time.
• To support the manufacturing section as and when required.
• Any other responsibility / task given by management/HOD from time to time.
• To maintain Harmony relationship with peers, seniors at work place and ensure the win - win situation for resolution of issues.
• Ensuring adherence to GMP, EHS standards, and SOPs across Block P through continuous monitoring.
• Responsible for maintaining departmental hygiene.
• To ensure that products are produced and stored in accordance with the appropriate documentation in order to obtain the required quality and monitoring of storage conditions for materials / products.
• To monitor and ensure strict implementation of all in process controls.
• To ensure that the production records are evaluated and signed by a designated person.
• To ensure proper maintenance of the department, premises, and equipment, as well as monitoring & controlling the manufacturing environment.
• To ensure that all required process validations, equipment calibrations are performed and that the corresponding reports are available
• To ensure that the required initial / continuing training of production personnel is carried out and adapted according to need.
• To ensure that documentation is maintained in accordance with the defined retention period
• To ensure that suppliers of materials are properly approved and regularly monitored.

Travel Estimate

Job Requirements

Education Qualification

B. Pharma / M.Sc. / M. Pharma

Experience

Tenure:  10 - 15 Years

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).