1. Strong understanding of USFDA/ MHRA/ EU or local guidelines


2. Responsible for setting strategy direction for the entire Production Department and team.


3. To enforce the batch manufacturing as per cGMP requirements in order to obtain high quality products.


4. To achieve targeted production with span of control.


5. To ensure the manufacturing equipment remains in validated stage


6. To co-ordinate with interdepartmental functional to carry out day to day activities in a smooth manner minimizing loss of the manhours.


7. To ensure maintenance plan of machines so as to reduce down time of machines which result in increase of product yield, productivity.


8. Management and valuation of the work performed by the subordinate staff to ensure implementation of GMP standards and SOP


9. To assure the in-house specification, SOPs and Master formulae and approvals.


10. To ensure the Quality policies of the company and compliance.


11. Readiness of production area for the Regulated Markets and lead the Regulatory audit team.


12. Compilation of daily, weekly and monthly reports and their submission to the leadership team.


13. To lead the plant’s Production plan &  team towards the goal of the organization


14. To ensure Safety norms as per EHS policy of the site, meet 100% guidelines.


15. Preparation of department’s budget & its executions.
    Communicating regularly with site leadership regarding problems or issues impacting production


16. Evaluating machine resources to ensure continued production and minimal downtime


17. Establishing a balance between increased productivity and reduced costs of manufacturing operations by setting productivity goals for each manufacturing team


18. Assess production standards in relation to plant capacity, materials supply, manpower availability and financial limitations.


19. Ensures that proper manufacturing validation is being done at appropriate intervals.


20. Ensures that all production equipment is maintained in good working order along with engineering department.

Skills

• Prevous experience in the production of Sterile Injectables (Solution & Immersion Products)


• Understanding of Microbiology aspects of sterile manufacturing


• Skillful in managing a large team (50-80)


• Familiar with all Regulatory Audits (EMEA, MHRA & SFDA)


• SAP RM/PM Modules