Affiliate Quality Manager (Responsible Pharmacist)

Job Description


Affiliate Quality manager and Responsible Pharmacist is responsible for Product Life cycle management, IRC issuance and renewal as well as health authorities’ communication at highest level of expertise on top of Interaction with business partners. The individual would be the contact point in all processes of Safety/quality/shipment/Audits. As Quality Manager he/she should promote quality and compliance excellence within the Affiliate by embedding quality principles throughout the organization. This is achieved through strong individual drive and close collaboration with other departments or key business representatives within or outside the Affiliate. and his/her main responsibilities would be as per below:

• Supervision on production
• GDP supervision and cold chain management
• Order and follow up on scratch labelling
• Stability report supervision
• Sampling and Reference Standard request
• Sample storage for each consignment for 6 months
• Quality check of consignment loggers and documentation
• TTAC process (from electronic filing, registration, release up to payment)
• Release permission documentation for BPs
• Post Marketing Study report to HA
• Pharmacovigilance reports
• Supervision on quality till expiry of products
• Product recall/HCP notification of safety concerns
• Deviation, excursion and complaint reporting
• Archive importation history for all shipped consignment
• Liaising with responsible pharmacist of importers, manufacturers & distributors
• Updated knowledge of regulation & principles of GXP (GMP, GDP, GSP, GLP) approved by IFDA, WHO and PIC/S
• Undertake, present and provide reports of portfolio analysis, market analysis for new business opportunities, as well as existing initiatives and performing statistical analysis on company data and preparing reports
• Lead the strategic projects in Iran aiming to provide more patients with innovative treatments

Requirements


- Doctorate degree in Pharmacy and valid Permanent Pharmacy License
- At least five years of experience in in Pharmaceutical/ Healthcare industry
- Superior English verbal and written communication skills
- Track record of project management experience in a complex and multiple project environment
- Strong analytical skills (data analysis – data interpretation – Data consolidation and reporting).
- Track record of working in a matrix environment
- Strong collaboration and communication skills
- Good network and knowledge of key IRFDA and MOH stakeholders beneficial
- Self-driven and likes working with autonomy
- Ability to travel

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