Job Ref. ID:
Team Lead - Quality Assurance - Non Sterile
UNITED ARAB EMIRATES
UAE (RAK head office)
Full Time Employment (Limited Contract)
Leading the Quality operations & Validation oversight for Respective site “Solids and Liquids dosage forms” nonsterile sites (Manufacturing and Packaging) in addition to leading IPC team in both sites, Responsible for the management of Deviations, Investigating in Complaints, CCFs “Change controls”, CAPA, APQRs, sites quality councils and QIP “Quality Improvement plan
Key responsibilities & Accountability:
Leading Site QA Operations in terms of Audit readiness and cGMP compliance.
Managing the IPC Team and samplers in Respective site
Responsible for developing Quality Generals SMEs for Deviations/ CAPAs management.
Accountable for Deviation management in Respective site
Responsible for the QA Operation investigation in Market complaints and OOS.
Responsible for assessing any change control and provide on-time impact assessment.
Responsible for CAPA effectiveness check for respective site
Ensure Quality incident associated with products manufactured and packed in Respective site are managed in line with Julphar QMS and designated regulatory procedures.
Responsible for implementing Quality improvement plan in respective site coordinating with CFTs to establish and spread the Quality Culture.
Responsible for the QA Operations KPI adherence and timely reporting for Respective site
Ensuring and spreading the culture of continues improvement and imbedding quality mindset in Respective site operation environment.
Identifies, develops and trains successors for the role, if needed, and coaches’ others in his/her area of expertise, ensuring other functions (e.g. operations) have enough product knowledge and understanding to execute their roles.
Bachelor/Master degree in science/ pharmacy
Minimum 8-10 years of experience in non sterile QA
Good Computer knowledge and knowledge of QMS system “Agile, Trackwise, Ampelogic”
Proficient in English.
Quality and Business decisions taker
Good Knowledge and command on cGMP
Risk Assessment knowledge
In terms of competency, you are highly result oriented with strong sense of accountability & ownership.
High on compliance adherence, having strong attention to detail, proactive and flexible
Good communication, interpersonal, and collaboration skills.
Having a demosnetrated skill in leadership and people management
Motivated, organized, focused & overall compliance.
Must be able to manage tasks, plan workload effectively, priorities and easily adapt to changing situations.
Ability to understand new learnings and implant in workplace.
Demonstrate a good capability in People management and conflict resolving
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