Job Ref. ID:
QA non sterile team leader
UNITED ARAB EMIRATES
UAE (RAK head office)
Quality Assurance - Non sterile team leader
Full Time Employment (Un-limited Contract)
The team leader is responsible for providing operational support, implementation and maintenance of a corporate Quality Assurance plan. This involves evaluating and enhancing Julphar’s total quality programs.
Will adhere with the cGMP principles and lead the QA operations activity for the non sterile manufacturing sites (Solids , Liquids and Semi solids) with ensured compliance
The QA team leader is a subject matter expert in Technical knowledge with Pharmaceutical cGMP guidelines and should lead the issuance & review of the quality documents issuance (SOP, Protocols, Assessments, etc.)
The incumbent will manage QIP as well as leading the continuous improvements and managing the quality projects and should be able to define the business & quality priorities
Key responsibilities & Accountability:
Key Responsibilities & Key Result Areas
• Leading site QA operations team and effectively implement quality management systems.
• Responsible for Line clearance, In-process quality checks, Environmental monitoring, GMP utility systems quality sampling and product sampling management.
• Collaborate with Quality Control, Manufacturing, Validation and Engineering functions to drive Quality awareness, facilitate Good Manufacturing Practices and implement continuous improvement plans to ensure Product Quality and monitor site KPIs.
• Should act as Lead for the product QRMs and investigations including deviations/Market complaints/OOS/Product recalls and ensuring effective root cause analysis and assigning of appropriate CAPAs.
• Perform a periodic quality review on batch documentation.
• Responsible for product and facility changes assessment.
• Responsible for review and approval of product PQR reports.
• Responsible for review of product master documents not limited to Batch records, Specifications, Stability Reports, product validation reports.
• Prepare and review of Annual Product Quality Review reports.
• Participation in Internal and Regulatory audits and assure site readiness for the GMP audits
• Actively participate in continuous improvement initiatives.
• Responsible for CAPA implementation and monitoring its effectiveness
• Responsible for On – Job training and people development.
• Solid Technical knowledge with strong implantation skill , people management skill
• 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)
• Should have Good technical knowledge - Non-sterile manufacturing process operations / technologies, and in handling CMC changes.
• KPI management, proven experience in conducting Risk Assessments.
• Problem Solving and high agility on taking right scientific decisions
• Departmental budgeting and basic finance knowledge is desirable
• Bachelors ( 4 years) / Masters in Pharmacy or Biochemistry or Chemistry
• MBA or MS in Quality Management a plus
• Minimum of 8+ years progressive experience in the quality assurance, manufacturing functions, or product release roles supporting commercial registered product operations having GMP approval from highly regulated authorities (HRAs) USFDA/MHRA/EU/TGA.
• Must be highly organized, self-motivated and experience in building or updating quality system for pharmaceuticals
• Solid track-record in Managing Quality System and handling FDA’s inspections
Copyright, All Rights Reserved | Julpharcareers 2020