الوصف الوظيفي
Technical Head
date posted 03/30/2022 contract type Full time job id R2640715 location Jeddah, Saudi Arabia
F
*or
Saudi National only – Based in King Abdullah Economic City.
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JOB PURPOSE
* Responsible for Functioning of plant operation full filling all Regulatory Requirement and cGMP Guidelines to ensure that the products manufactured are of the required Quality for their intended of use. * Responsible for all Quality and Production department, Warehouse and Maintenance. * Represent as unique authorized person in front of any Regulatory and Governmental affairs such as but not limited to: SFDA, Customs Clearance, ECA, Chamber of Commerce.
KEY RESULTS / ACCOUNTABILITIES
* Ensure compliance of the Industrial Affairs operational process with the regulatory authority requirement and cGMP/Sanofi Requirements. * Lead and coordinate contact with SFDA for all technical and regulatory related to the Industrial Affairs. * Manage all Quality, Production and Warehouse operations and assume the full responsibility of daily operations of the linked Units in absence of Unit Managers of Production, Warehouse and Quality. * Final Approval of all the GxP activities, procedures and processes such as but not limited to: + Raw materials & Packaging Materials Suppliers. + All outsourced technical activities & services. + Majors changes in the plant facility/Production Lines/Product Formula. + Job Description for the key positions in Quality, Production, Maintenance and Warehouse. + Legal/regulatory responsible for all product release to the market. + Legal/regulatory responsible for all product complaints/Recall. + Legal/regulatory responsible for all Major and Critical events. + Technical dossiers intended for registration in Saudi FDA. * Periodic Evaluation of the quality System in the plant and approving of continuous development/improvement plans. * Responsible for hiring the employees of the reportees departments.
People Leadership
Performance manages the team through setting and reviewing priorities. Provides appropriate and timely feedback about performance and coaches team members to help them achieve their goals. * Supports the professional and career development of the team by identifying the skills and competencies that employees need for their current and prospective roles and provide opportunities to learn and practice new skills. * Leads the building of a motivated and engaged team through the use of formal and informal recognition, regular communications and the encouragement of cooperation between individuals and teams. * Ensure that the HSE policy is communicated to all employees. * Identify training needs and organize training interventions to meet area process technical standards. * Plans, promotes, and organizes training activities related to product quality and reliability. * Responsible with cooperation with HR for the development plan of Quality, Production and Warehouse team to improve their capabilities and professional skills.
Maintain Compliance
* Respect of personal data protection charter. * Ensure implementation of all SFDA requirements (Including new ones). * Monitoring progress on quality-related corrective and preventive actions (CAPA) linked to manufacturing & repackaging activities to assure timely compliance and continues improvement. * Identify root causes of deviation or non-compliance and put in place CAPA with regular follow up. * Develop, recommend and monitor corrective and preventive actions. * Evaluate audit findings and implement appropriate corrective actions. * Follow up CAPA of regulatory audits and self- inspection. * Perform other duties as assigned. * Approval of all SOPs that may impact GxP or other regulated activities. * Final approval of the investigation report.
Ethical Leadership
* Respect of Company’s values, Code of Ethics and Social Charter. * Responsible for safety of subordinates from ethical and legal prospective.
Environmental and Safety Leadership
To care for his own safety and wellbeing and the safety of others, and to co-operate with the company to ensure a safe place of work. Employees are therefore expected to: * Assist in the investigation of accidents with the objective of introducing measures to prevent recurrence Thoroughly read all safety documentation issues by the Company and comply with its requirements. Escalate any doubts or uncertainties to The direct manager. * Support and conform to Company safety rules and procedures to ensure a safe and healthy working environment. * Report any accident, incident or near miss, whether it be of personal injury or property damage. * Follow the approved HSE policy and requirements. * Follow the approved HSE SOPs. * Follow the emergency plan procedures. * Follow the adequate implementation of the PASS at the due dates. * Follow the adequate implementation of the Risk assessment, inspections and audits corrective actions at the due date. * Immediate reporting to any incident or accident occurring at each area. * Considering all HSE requirements during new projects feasibility evaluation.
KEY WORKING RELATIONSHIPS
INTERNAL
Cross Functional Collaboration with:
* Site Leader Team. * Sanofi Corporate Quality. * Sanofi Sites Middle East and others.
EXTERNAL
Would be expected to be involved with:
* SFDA and any other regulatory and Governmental sectors. * Suppliers. * Third Party (Service Provider). * Any other Local Administrative Sectors or External suppliers linked to the Industrial Affairs.
SKILLS, EXPERIENCE & KNOWLEDGE REQUIREMENTS
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Education Level
Bachelor’s Degree in Pharmacy. Master Degree is a plus. Valid registration at Saudi Commission for Health Specialties. *
Experience
Minimum of three years experience in Pharmaceutical field. Previous experience in a Multinational company is a plus. *
Skills
Fluency in Arabic – Fluency in English. Communication skills. Ability to work under pressure. Managerial Skills: Think Strategically- Develop People- Lead Teams- Make Decisions. Act for Change. Strive for Results. Cooperate Transversally. Commit to Customers.
PLAY TO WIN BEHAVIOUR
* Stretch. * Take Action. * Act for Patients and Customers. * Think Sanofi First. At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
تفاصيل الوظيفة
منطقة الوظيفة جدة, المملكة العربية السعودية
قطاع الشركة الاستشارات الهندسية العامة
طبيعة عمل الشركة غير محدد
نوع التوظيف غير محدد
الراتب الشهري غير محدد
عدد الوظائف الشاغرة غير محدد
https://www.bayt.com/ar/saudi-arabia/jobs/technical-head-64461484/