Purpose : The Affiliate & distributorQuality Team Lead is expected to ensure the adherence with cGMP principles and to maintain them in an effective manner.
The Team leaders will be responsible for the compliance ofQuality management system for all Julphar affiliates anddistributors.
The incumbent is mainly responsible forquality oversight for RA / PV / non-operational departments in Julphar RAK and all other affiliates.
Must ensureend to end responsibility and completion of Tasks for distributorprocess (qualification, selection, oversighting andre-qualification).
Moreover, he / she will be responsible toface external quality audits regulatory / customer audits hosting and audit management.
Keyresponsibilities & Accountability : Key Responsibilities
Setup of system for distributor management that ensures : a. Local Complaint handling and Coordinationactivity (Receiving, investigating, response andclosure).
b. Product Surveillanceactivityc. Recall management d. CorrectiveAction executione. Local market Release of productsaccording to GMP and Julphar quality system whenneededf.
Deviation and non-conformitieshandling. g. Change controlcommittee.
System in Place for following GDP atall warehousing activities.
Ensure compliancewith current Good Manufacturing Practices, Good DocumentationPractices, applicable ISO standards and other areas ofmandatory regulatory oversight.
processes neededfor the quality management system are established andmaintained.
Maintain proper system relatedKPIs’ and trending in a way that allow continuousimprovement culture.
Evaluation of alldistributors through which Julphar is channeling their Finishedgoods or carrying out any storageactivities.
Ensure product storage is compliantwith GDP and GCC / WHO guidelines.
Keeps up to datewith all relevant regulations (GXP, GMP, ICH, WHO, FDA, ISO etc.);in compliance withregulations.
Establish SOP's based onQMS, and revise them as necessary. Manage SOP's based onrelated procedures
Lead team for RA / PVintelligence to ensure the final submitted documents toHAs’ are in compliance with procedures andguidelines.
Ability to present and articulateissues for resolution, communicating regularly with key stakeholders to ensure alignment, provide support as ascientific / technical resource for raised changes andprojects, share experience with colleagues
Review andapprove as quality assurance representative forPV(Pharmacovigilance) relevant documents.
Ensure that any healthauthorities communication are correct, tracked and implemented as committed.
Monitor monthly performanceand function KPIs to ensure the organization objectives in the areas of cost, efficiency, and compliance aremet.
Responsible for preparation, execution andaftercare of any such Improvement Projects within theassigned workarea. Qualifications : -Education Bachelor’s degree in Pharmacy / Chemistry,Masters degree is a definite advantage - Experience : Experience of minimum 7-10 years in Pharmaceutical Industrypreferably in Quality Management systems.
Must have provenexperience in in market quality and distributormanagement
Previous experience in asimilar role and with experience in a Pharmaceutical / HealthcareIndustry is preferred - Training : Key Competencies :
In terms of Competency you are highly result orientedwith strong sense of accountability & ownership,
Excellent communication, interpersonal andpresentation skill.
Technical Competencies : In-depth knowledge of the industry's standards andregulations guidelines excellent knowledge of reportingprocedures and record keeping, must have experience inhandling Regulatory Authorities audits and questions andaccordingly set up the action plan
Businessacumen partnered with a dedication to legality is essential forbetter fitment
Customer-oriented approach with strongaptitude and innovative flair of mind
Having an Analyticalmind with ability to think diversely and understand the bigpicture, Methodical and diligent with outstanding planningabilities an analytical mind able to "see" the complexities of procedures and regulations
StrongManpower handling skills and having effective team communicationand motivational skills.
Capable ofsuggesting ideas in a structured manner and having good Command onEnglish language.
You are a team playerwith a proactive and collaborative approach and enthusiasticallymanage stakeholders in goodspirit. Technical Competencies :
ExtensiveKnowledge in cGMP ,GDP ,PV and regulatoryguidelines.
Knowledge in strategic and businessplanning will be an advantage
Must be experienced inmanaging complex and sensitive operationalchallenges.
Knowledgeable with SOP writing, GMPcompliance.
Strong IT skills, inter personalskills and technical knowledge.