QA Senior Specialist (QC oversight) - Sterile

Maintain oversight of the QC activities including testing, Out Of Specifications (OOS), Out Of Trend (OOT) , perform investigations to maintain GMP and quality standards.
Key responsibilities & Accountability:
Ensure effective and full implementation of GMP related requirements to Laboratory Practices
Comply with Julphar information security and policies
Comply with Data integrity, privacy declarations and procedures
Investigate lab associated deviations and OOS
Providing CAPA for relevant departments from deviation reporting to close identified gaps
Contribute in Technical Risk Assessments for analytical method validations
Maintain all system inspection ready & presenting lab deviation & OOS/OOT reports to internal & external audits
Escalate of any schedule predicted delays, deviation outcome issues in a timely manner for Team leader & Management decision making
Actively participate & value add in continuous improvement initiatives.
Support the CAPA implementation and monitoring its effectiveness
Conduct & support the for On Job training wherever needed
Reviewing and approving master technical documents including:
Raw Material Specification (RMS)
Raw Material Purchase Specification (RMPS)
Standard Test Method (STM)
Test Method Validation Protocols (TMRP)
Test Method Validation Reports (TMVR)
Standard Operating Procedure (SOP) QA/QC
Stability Protocols/Reports
Lead and closing up laboratories investigation for:
Raw Material and finished product analysis out of specifications (OOS)
Stability out of specifications (OOS)
Microbiology deviations
Deviations related to QC & QA Operations
Market Complaint
Any other responsibilities assigned by QA Head and QA Manager.
Core Competency
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.
Must be able to manage tasks and priorities and easily adapt to changing situations.
Good command in English (Communicating, writing and speaking)
Good prioritizing skills and being able to make a just decision also in case of (time) pressure
Flexible learning abilities
Excellent knowledge of cGMP and strong focus on clients and quality/compliance;
Excellent root cause analysis capabilities, Innovative abilities, creative, strong drive to improve
Must be highly organized, self-motivated to learn new things and implement them in building or updating quality system for Pharmaceuticals
Process the ability to develop and maintain an effective working relationship with internal and external sections, function as team player and comply with company policies.
Qualifications:
- Education
Master Degree in (Bio)Pharmacy or related other science
- Experience:
A minimum of 6+ years of relevant experience in similar industry (preferably in a sterile environment)
Must have a background in Biotech/ sterile QC testing data review/ trending
- Training:
Key Competencies:
Preferable to have prior experience with Insulin production process
Preferable experience in Minitab
Have strong leadership skills.
Technical Competencies:
Data Analytics/ Experience in Statistical Process Control