Title:  Team Leader - QA (Lactam VS)

Job Description:

1.       Should manage sterile and non-sterile plants (sterile Powder filling and OSD (PPS, tablets, and capsules)).

2.       Facilities risk assessment (process, Facility, and Equipment’s)

3.       Leading Site QA Operations in terms of Audit readiness and cGMP compliance.

4.       Managing the IPC Team and samplers in the Respective site

5.       Developed Quality Generals SMEs for Deviations/CAPA management.

6.       Accountable for Deviation management in Respective site

7.       Responsible for the QA Operation investigation in Market complaints and OOS.

8.       Responsible for assessing any change control and providing on-time impact assessment.

9.       Responsible for CAPA effectiveness check for the respective site 

10.     Ensure Quality incidents associated with products manufactured and packed in Respective sites are managed in line with Julphar QMS and designated regulatory procedures.

11.     Responsible for implementing Quality improvement plans in respective sites coordinating with CFTs to establish and spread the Quality Culture.

12.     Responsible for the QA Operations KPI adherence and timely reporting for Respective site

13.     Ensuring and spreading the culture of continuous improvement and embedding a quality mindset in the Respective site operation environment.

14.     Identifies, develops, and trains successors for the role, if needed, and coaches’ others in his/her area of expertise, ensuring other functions (e.g. operations) have enough product knowledge and understanding to execute their roles.

 

Core Competency

•         In terms of competency, you are highly result-oriented with an intense sense of accountability & ownership.

•         High compliance adherence, having strong diligence, initiative-taking, and flexibility.

•         Excellent communication, interpersonal, and collaboration skills.

•         Having a demonstrated skill in leadership and people management

•         Motivated, organized, focused & overall compliance.

•         Must be able to manage tasks, plan workload effectively, prioritize, and easily adapt to changing situations.

•         Ability to understand new learnings and implant them in the workplace.