Job Ref. ID:
Team Leader (Raw Materials)
UNITED ARAB EMIRATES
UAE (RAK head office)
Full Time Employment (Limited Contract)
The role of Team Leader is to carry out ,OOS & Deviation investigation ,ability training and supervision for analysts ,SOP revision knowledge usually through operation of various QC equipment. It will be requested from Team Leader to adhere with cGMP principles and to maintain them in an effective manner. He or she will use computer program that undertake handling and data entry as tables and reports.
Key responsibilities & Accountability:
Supervising and follow up analyst and lab activities for Raw Material labs.
Responsible for supervision the analysis of Raw Material labs.
Responsible for the operation of various QC equipment (depending on the section he working)
Communicate with production for smooth work flow.
Prepare to follow GLP, GMP and safety procedures and maintain hygienic conditions in lab.
Training of the newly joined staff.
Review/approve SOPs and work instructions.
Ensure all cGMP stability data are managed and evaluated as described in relevant internal SOPs (including OOSs/ deviations)
Complete corrective and preventive actions assigned by investigations or audit observations
Review and approve protocols and reports such as method validation, method transfer, process validation and stability.
Responsibility for adherence and timely completion of Quality systems processes OOS, OOT & investigations in line with current SOPs.
Good basis and familiarity in various analytical techniques.
Ensures Date Integrity implementation and follow up as per Regulations and Company Protocol.
Execute and approve all laboratory investigations.
Implement changes handled through change control system and review change controls.
Handling and supervision of Tech transfer project.
Shall be authorized designee for responsibilities of QC Manager.
Graduate of Bachelor/Master of Science in Chemistry or Chemical Engineering or Pharmacy.
At least 8-10 years’ experience in Pharmaceutical Industry is required.
Previous experience in a similar role is preferred for better fitment of this role.
Strong Knowledge with SOP writing, GMP compliance and data integrity requirements (21 CFR Part 210/211, Part 11) and analytical instrument qualification (USP 1058).
Must be experienced in managing complex and sensitive operational challenges.
Proven experience with computer system validations including leading, developing and implementing validation strategies and authoring required validation documents.
Good command in English (communicating, writing and speaking) and Arabic is preferred.
Good Knowledge in MS Office (MS Excel and MS Word, etc.).
In terms of Competency you are highly result oriented with strong sense of accountability & ownership.
Motivated and highly organized professional and should be able to juggle competing priorities, with high level of integrity and professionalism.
Strong organizational, planning and technical skills required.
Excellent communication, interpersonal and presentation skill.
In-depth knowledge of the industry's standards and regulations guidelines excellent knowledge of reporting procedures and record keeping/
Business acumen partnered with a dedication to compliance is essential for better fitment
Having an analytical mind with ability to think diversely ,diversely, resolve problems with outstanding planning skill to manage & expedite complexities of procedures and regulations
Ability to work under pressure, plan personal and team workload effectively and delegate.
You are a team leader with a proactive and collaborative approach.
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