Must ensure end to end responsibility and completion of Tasks for distributor process (qualification, selection, oversighting and re-qualification).
Moreover, he/she will be responsible to face external quality audits regulatory/customer audits hosting and audit management.
Key responsibilities & Accountability:
Setup of system for distributor management that ensures :
a. Local Complaint handling and Coordination activity (Receiving, investigating, response and closure).
b. Product Surveillance activity
c. Recall management
d. Corrective Action execution
e. Local market Release of products according to GMP and Julphar quality system when needed
f. Deviation and non-conformities handling.
g. Change control committee.
System in Place for following GDP at all warehousing activities.
Ensure compliance with current Good Manufacturing Practices, Good Documentation Practices, applicable ISO standards and other areas of mandatory regulatory oversight.
processes needed for the quality management system are established and maintained.
Maintain proper system related KPIs and trending in a way that allow continuous improvement culture.
Evaluation of all distributors through which Julphar is channeling their Finished goods or carrying out any storage activities.
Ensure product storage is compliant with GDP and GCC/WHO guidelines.
Keeps up to date with all relevant regulations (GXP, GMP, ICH, WHO, FDA, ISO etc.); in compliance with regulations.
Establish SOP's based on QMS, and revise them as necessary. Manage SOP's based on related procedures
Lead team for RA/PV intelligence to ensure the final submitted documents to HAs are in compliance with procedures and guidelines.
Ability to present and articulate issues for resolution, communicating regularly with key stakeholders to ensure alignment, provide support as a scientific/technical resource for raised changes and projects, share experience with colleagues
Review and approve as quality assurance representative for PV(Pharmacovigilance) relevant documents.
Ensure that any health authorities communication are correct, tracked and implemented as committed.
Monitor monthly performance and function KPIs to ensure the organization objectives in the areas of cost, efficiency, and compliance are met.
Responsible for preparation, execution and aftercare of any such Improvement Projects within the assigned work area.
Bachelor s degree in Pharmacy / Chemistry, Masters degree is a definite advantage
Experience of minimum 7-10 years in Pharmaceutical Industry preferably in Quality Management systems. Must have proven experience in in market quality and distributor management
Previous experience in a similar role and with experience in a Pharmaceutical/ Healthcare Industry is preferred
In terms of Competency you are highly result oriented with strong sense of accountability & ownership,
Excellent communication, interpersonal and presentation skill.
Technical Competencies: In-depth knowledge of the industry's standards and regulations guidelines excellent knowledge of reporting procedures and record keeping, must have experience in handling Regulatory Authorities audits and questions and accordingly set up the action plan
Business acumen partnered with a dedication to legality is essential for better fitment
Customer-oriented approach with strong aptitude and innovative flair of mind
Having an Analytical mind with ability to think diversely and understand the big picture, Methodical and diligent with outstanding planning abilities an analytical mind able to "see" the complexities of procedures and regulations
Strong Manpower handling skills and having effective team communication and motivational skills.
Capable of suggesting ideas in a structured manner and having good Command on English language.
You are a team player with a proactive and collaborative approach and enthusiastically manage stakeholders in good spirit.
Extensive Knowledge in cGMP ,GDP ,PV and regulatory guidelines.
Knowledge in strategic and business planning will be an advantage
Must be experienced in managing complex and sensitive operational challenges.
Knowledgeable with SOP writing, GMP compliance.
Strong IT skills, inter personal skills and technical knowledge.