Process Lead - Complaint & Recall

Job Description

Process lead Complaints & Recall the role holder primary responsibility will be managing of the products complaints on daily basis in terms of communications.
Review of investigation and closure as well as handling the recall process with all concerned parties and calling for PIRC committee. In addition will also be responsible for the CAPA closure systems in terms of effectiveness check and act as an independent reviewer.
Key responsibilities & Accountability:
Key responsibilities & key result areas
The role holder is responsible to handle products complaint on daily basis, provide appropriate solutions and alternatives within the time limits and follow up ensure proper acknowledgement is done in a timely manner.
Identifying and addressing the root cause of complaints will help to prevent the recurring of complaints
Initiate the complaints on the system and ensure the appropriate timelines are adhered to
Share the final investigation outcomes of the complaints and close properly
Manage Recall process end to end including the communications and reconciliation confirmation
Responsible for closure of CAPA actions after performing independent review to ensure proper closure
Responsible for reviewing & approving extensions as per the LSOP for CAPA Management
Oversight for the Deviation management process and notify the OQ team of timeline non conformities
Weekly reporting for Complaints, recalls , CAPA closure and deviation performance
Create Continuous Improvement Framework for QMS systems in scope.
Accomplish goals and organization mission by completing related results as needed.
Core Competency
In terms of competency you are highly result oriented with strong sense of accountability & ownership.
Customer Oriented approach and having problem solving abilities with high agility on taking right decisions
Strong implementation and influencing skills.
In-depth knowledge of the industry's standards and regulations guidelines excellent knowledge of reporting procedures and record keeping
High on communication, interpersonal and collaboration skills required,
and easily adapt to changing situations.
Ability to create cross functional relations and manage conflicts.
Qualifications:
- Education
4 years Bachelor in Pharmaceutical/ Life Sciences /any discipline in same field.
Master degree is a plus.
- Experience:
Total 6-8 years of experience pharmaceutical industry with minimum 5 years in Quality management.
Prior experience in handling similar role will ensure better fitment.
- Training:
Key Competencies:
Excellent command in English (Communicating, writing and speaking).
Proficient in MS Microsoft office and computer knowledge.
Proven track record in systems initiation and KPI design
Proven experience in sterile & Biotech technologies.