Manufacturing Quality oversight on all TS (Solution Preparation to Sealing). Develop succession planning for the Quality Unit.
1.Lead and monitor Quality Oversight for operation from Solution preparation to sealing to ensure compliance to cGMP systems and procedures
2.Managing and coordinating all quality functions within manufacturing area.
3.Ensure manufacturing policies, procedures and standards confirm to predefined regulatory (US FDA/India /EU etc), site standards / specification and corporate standards.
4.Work with manufacturing supervision to resolve issues with compliance.
5.Update SOP/SOI/SCI procedure as necessaryto address continuous improvement opportunity.
6.Update SOP/SOI/SCI procedure as necessaryto address continuous improvement opportunity.
7.Work with manufacturing supervision to resolve issues with compliance.
8.Update SOP/SOI/SCI procedure as necessaryto address continuous improvement opportunity.
9.Conducts data analysis, investigation of processing exception and ensure sufficient resources to revise gap document, corrective action /preventive action and ensuring the effectiveness of these actions.
10.Involve in the site quality audit and identifying corrective and preventive actions.
11.Involve in designing /preparedness of manufacturing of exhibits batch /submission /launch of commercial batches.
12.Ensure Exceptions, online activities, any process changes are followed for manufacturing as per defined site procedure.
13.Ensure Batch manufacturing record review completion.
14.Review, approve and certify master reports documents like SOP, SOI, SCI, batch records, validation protocol and reports.
15.Ensure training and qualification of department personnel
16.Conduct performance reviews with direct reports.
17.Adherence to Safety Procedures/GMP & GDP Practices.
18.Involve in the site quality audit and identifying corrective and preventive actions.
19.Involve in designing /preparedness of manufacturing of exhibits batch /submission /launch of commercial batches.
Technical Skills -
1.Knowledge of Validation of facility, equipment, manufacturing processes and cleaning methods used in manufacturing of 2.
2.sterile/terminal sterilized and dosage forms.
3.Must possess skills / abilities in the following
Reviewing batch manufacturing records and other QMS documents and reports
4.Leading investigations, arriving at RCA and implementing CAPA
5.Interpreting and guiding effective quality systems implementation
6.Presenting training programs
7.Coaching shop-floor manufacturing staff
8.Handling regulatory inspections from USFDA/ MHRA/TGA, etc.
Standards, Processes & Policies -
1.GMPs and regulations governing manufacturing operations for sterile products
2.Global Hospira quality policies and procedures.
Behavioral / Any Other Skills -
1.Leadership and decision making skills
2.Strong interpersonal skills
3.Able to make independent decisions impacting batch manufacture on the floor
4.Analytical thinking to grasp complex analytical issues and provide the feasible solutions.
5.Able to Effectively communicate.