Process Lead - Inspection Readiness

Job Description

Lead Inspection Readiness Activities including developing Inspection Readiness Tracker, hold weekly meeting with Site Compliance Staff to delegate tasks and manage updates.
Key responsibilities & Accountability:
Key responsibilities & key result areas
The role holder will be responsible for leading the Inspection readiness program in Julphar across all 12 sites. This includes walk through, GEMBA and escalating the status to the Quality council
Providing look out for the upcoming 6 months to ensure readiness is in place and highlight of major gaps where required.
Lead Inspection Readiness Activities including developing Inspection Readiness Tracker, hold weekly meeting with Site Compliance Staff to delegate tasks and manage updates.
Accountable for the preparation of audits, daily summary preparation, and coordinate responses and CAPA follow-up.
Manage all external inspections including room set up, Inspection Team Assignments, document flow, clean up, and document storage. Manage Inspection from the Control Room.
Manage Regulatory Audit responses including determining CAPA Owners, putting CAPAs into Amplelogic, tracking CAPAs to completion. Developed CAPA Clinic where SMEs attend to discuss their CAPAs and any roadblocks they are facing with completion.
Compile Inspection Readiness information such as Inspection Storyboards and Proof Books.
Monitor progress of the preparation of the inspection and report milestones, risks identified and remediation actions
Suggest process improvements to senior QA management (e.g.: tools, quality docs, KPIs )
Ensure adequate documentation to support inspection available through end to end processes (e.g.: Quality Documents, CAPA plan status )
Assist with compilation of weekly and monthly metrics as needed
Accomplish goals and organization mission by completing related results as needed.
Maintain and promote a teamwork environment with effective and clear communication amongst colleague.
Core Competency
Solid Technical knowledge with strong implantation, and influencing skills.
High on communication and collaboration, having an ability to manage multiple stakeholders at a time
In terms of competency you are highly result oriented with strong sense of accountability & ownership.
Strong communication, interpersonal, and implementation skills required.
In-depth knowledge of the industry's standards and regulations guidelines excellent knowledge of reporting procedures and record keeping
Must be able to manage tasks and priorities and easily adapt to changing situations.
Ability to create cross functional relations and manage conflicts.
Problem Solving and high agility on taking right scientific decisions
Qualifications:
- Education
4 years Bachelor in Pharmaceutical/ Life sciences / Engineering /any discipline in same field.
Master degree is a plus.
- Experience:
At least 6 -8 years of experience pharmaceutical industry sector with experience in passing regulatory inspections and aware of the inspection readiness programs.
Should have handled similar role for 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
Should have proven experience in SFDA and GCC audits