Job Title : QA non sterile team leaderDivision : QUALITY ASSURANCE Country : UNITED ARAB EMIRATES WorkLocation : UAE (RAK head office) Job Type : Quality Assurance - Nonsterile team leader Employment Type : Full Time Employment(Un-limited Contract) JobDescription : Purpose : The team leader is responsible for providing operational support,implementation and maintenance of a corporate Quality Assuranceplan.
This involves evaluating and enhancing Julphar’stotal quality programs. Will adhere with the cGMP principles andlead the QA operations activity for the non sterile manufacturingsites (Solids , Liquids and Semi solids) with ensured complianceThe QA team leader is a subject matter expert in Technicalknowledge with Pharmaceutical cGMP guidelines and should lead theissuance & review of the quality documents issuance (SOP,Protocols, Assessments, etc.
The incumbent will manage QIP as wellas leading the continuous improvements and managing the qualityprojects and should be able to define the business &quality priorities Key responsibilities & Accountability : Key Responsibilities & Key Result Areas
Leadingsite QA operations team and effectively implement qualitymanagement systems.
Responsible for Line clearance,In-process quality checks, Environmental monitoring, GMP utilitysystems 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 continuousimprovement plans to ensure Product Quality and monitor site KPIs.
Should act as Lead for the product QRMs andinvestigations including deviations / Market complaints / OOS / Productrecalls and ensuring effective root cause analysis and assigning ofappropriate CAPAs.
Perform a periodic quality review onbatch documentation.
Responsible for product andfacility changes assessment.
Responsible for review andapproval of product PQR reports.
Responsible for reviewof product master documents not limited to Batch records,Specifications, Stability Reports, product validation reports.
Prepare and review of Annual Product Quality Reviewreports.
Participation in Internal and Regulatory auditsand assure site readiness for the GMP audits
Activelyparticipate in continuous improvement initiatives.
Responsible for CAPA implementation and monitoring itseffectiveness
Responsible for On Jobtraining and people development. Core Competency
SolidTechnical knowledge with strong implantation skill , peoplemanagement skill
High on communication and collaboration, having an ability to manage multiple stakeholders at a time
In terms of competency you are highly result orientedwith strong sense of accountability & ownership.
Must be able to manage tasks and priorities and easily adapt tochanging situations.
Good command in English(Communicating, writing and speaking)
Should have Goodtechnical knowledge - Non-sterile manufacturing process operations / technologies, and in handling CMC changes.
KPImanagement, proven experience in conducting Risk Assessments.
Problem Solving and high agility on taking rightscientific decisions
Departmental budgeting and basicfinance knowledge is desirable Qualifications : - Education
Bachelors ( 4 years) / Masters in Pharmacy orBiochemistry or Chemistry
MBA or MS in QualityManagement a plus - Experience :
Minimum of 8+ yearsprogressive experience in the quality assurance, manufacturingfunctions, or product release roles supporting commercialregistered product operations having GMP approval from highlyregulated authorities (HRAs) USFDA / MHRA / EU / TGA.
Training : KeyCompetencies :
Must be highly organized, self-motivatedand experience in building or updating quality system forpharmaceuticals Technical Competencies :
Solidtrack-record in Managing Quality System and handlingFDA’s inspections