Title:  QC Section Head - Raw Material

                                           JOB DESCRIPTION                                         

POSITION SUMMARY

Responsible for Raw material section w.r.t. Sampling, Testing and Release of Raw material section in Quality control department. Additionally responsible for review and approval of respective QMS like Change control, CAPA, Lab Event, OOS, OOT, Incident, Action item in Track wise.

The incumbent will assure individual compliance with the all concerned regulatory requirements, GxP’s and applicable department programs, including training, documentation, Standard Operating Procedures, and Sun Pharma Global Quality Policies, Standards and Procedures.

Key responsibilities:

1. Monitoring, Planning and execution activity of all Raw Material, GC, HPLC, RM Sampling.
2. Monitoring of analyzing samples received for Investigation, event, market complaint and Pharmacopoeial evaluation.
3. Document submission for Product Registration, Planning of execution on document preparation and submission for Regulatory filling.  
4. Troubleshooting / Training to analyst on regular basis to improve Lab system.
5. Responsible and overview to QC Laboratory Raw Material Department (i.e. GC, HPLC, RM Sampling, etc.).
6. Approve change control, CAPA, Lab Event, OOS, OOT, Incident, Action item in Track wise with respect to QC related activity.
7. Handling of Internal / external audits and compliance activity.
8. Handling of track wise, LMS and Empower software.
9. Timely review, execution and closing of Quality alert and Field alert reports.
10. Timely review, closing and approval of OOS, OOT, laboratory events report in track wise.
11.  Follow the EHS policy, standard operating procedures and maintain the compliance to GMP    requirements.
12.  Handling of Field alert reports and co-ordination in the product recall.                 
13.  Providing early alarms and feedback for Quality Improvements.

EDUCATION/EXPERIENCE REQUIREMENTS

•  M. Sc. In Chemistry
•  15 years’ experience in QC in pharmaceutical industry.

REQUIRED SUCCESS ATTRIBUTE

Knowledge of GxP’s, cGMP and other regulatory requirements.

Primary Attributes

• Planning and Prioritization
  Collaboration
  Accountability
  Compliance
  Customer Service orientation

• Secondary Attributes
  People Connect
  Attention to detail
  Emotional control
  Effective Communication & Problem solving

WORKING ENVIRONMENT/PHYSICAL REQUIREMENTS

Incumbent performs work assignments as per business requirement in Quality control. The incumbent is capable to comply with commitment for the business requirements for QC testing and release.

This job description is intended to describe the general nature and level of work being performed by the person assigned to this position.  The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job. 

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position.  There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.