Job Detail

1 To monitor the compliance with the requirements of Good Manufacturing Practice

2 Ensure that the batches are manufactured as per production plan without any delays

3 Adherence to the standard operating procedures and ensure the team is following the defined procedures

4 Production planning and inventory control : Responsible for ensuring the availability of Raw material prior to start of batch

5 DS dispensing in coordination with team and ensure timely release of batches

6 Ensure the GMP documents are reviewed and submitted to QA as per the SLA

7 Investigation of non-conforming/Deviations/OOS/OOT and implementation of CAPA. To ensure these documents are closed on time as per SLA

8 Ensuring to maintain the qualified status of all the production equipment in coordination with CFT

9 Regular maintenance of production equipment in coordination with engineering and maintenance department 

10 Planning for CAPEX and OPEX requirements 

11 To initiate, coordinate and verify the CAPA taken against the nonconformance observed during the audit

12 Guiding the team members in the preparation, hazard and risk assessment register, aspect/impact register and reviewing the adequacy

13 To follow the established procedures and policies of the company pertaining to EHS and ensuring effective implementation of EHS management system .Reviewing the progress/status of EHS objectives & targets periodically

14 Responsible for giving objectives and proper utilization production personnel

15 Training and evaluation of production personnel and there by minimise the manual errors

16 Adherence to plans towards execution of commercial, clinical and developmental campaigns in compliance to pre-defined Quality and Safety procedures

17 Responsibility of functions and the people for continuous improvements in both functional competencies, career tracks and employee engagement

18 Establish product Life cycle management through validation cycle and continuous improvements towards high throughput. To maintain the quality and robustness of the process

19 As and additional responsibility to involve for all the activities related to Downstream purification -1, Downstream purification -2 and Buffer Preparation Area 

20 To ensure availability of  Personnel and schedule the requirements accordingly

21 Responsible for OTIF execution of  all the activities related to Downstream purification-1 and Buffer Preparation area as per the production plan

22 To have a visibility on SAP operations and  get trained on basic requirement