Job Ref. ID:
Manager - Manufacturing Compliance - Sterile
Technical Operation - Manufacturing Compliance
UNITED ARAB EMIRATES
UAE (RAK head office)
Manager - Manufacturing Compliance - Sterile
Full Time Employment (Un-limited Contract)
The Manager –Manufacturing Compliance is responsible to provide the oversight for the GMP compliance systems of manufacturing sites for continual improvements and closely work with site heads of Manufacturing, Engineering, and Warehousing Management. The role holder must implement & support the review mechanism for structured evaluation of Sites Operational procedures to identify the cGMP risks and implement remediation plans. The role holder focuses on better value and quality, responsible for compliance.
Responsible to ensure adherence to GMP Compliance and Quality Systems requirements specific to the Manufacturing operations. Responsible for establishing and maintaining Manufacturing Compliance governance, processes and improving overall Operating unit’s technical capability.
Key responsibilities & Accountability:
All plants in RAK.
Key Responsibilities & Key Result Areas
• Assess GMP Compliance Systems and works with the Manufacturing site Heads for required improvements to meet the group and organizational goals.
• Support data-driven insights into business performance and opportunities for improvement in Inspection Readiness and Inspection Management, Regular on-site visits to manufacturing sites to assist in inspection readiness activities, execution, CAPA response, and remediation.
• Facilitate gap analysis for the observations from site visits and regulatory inspections and provide short term and long-term remediation plans.
• Utilizes manufacturing process knowledge and investigational skills to identify and resolve manufacturing issues and drive continuous improvement in process operations.
• Implement best practices as applicable to the industry and compliance with statutory regulations.
• Facilitate the roll-out of new compliance programs in the manufacturing sites.
• Involve in the review process of Change Management, Deviation Management and Complaint Management activities related to Manufacturing operations.
• Ensure that the required initial and continuing training of the department personnel related to GMP, Quality Systems, Inspection readiness and Manufacturing Compliance activities is carried out and adapted according to the needs of the Organization in coordination with HR and training department.
• Support & lead the manufacturing compliance review meetings to discuss the operational metrics with focus on quality systems and process improvements.
• Participate in the quality council meetings and support to identify the opportunities for continual improvement.
• Review the system related operating procedures (SOPs), Job Descriptions, On Job Training schedules, Organograms, and drawings of facilities/Utilities of the Manufacturing sites are up to date and comply with Julphar Quality Systems.
• Responsible for BMR and BPR system improvement in coordination with Quality
• Adhere with the cGMP principles and maintain them in an effective manner. Ensuring compliance with all applicable regulations, work performed in area of responsibility is conducted in right manner.
• Bachelors / Master’s degree in Science / Pharmacy.
• Professional experience in similar compliance management role in pharmaceutical organizations is mandatory.
• At least 10-12 years of experience of relevant strategic and tactical leadership experience in the Manufacturing process and Quality for issues that impact manufacturing operations in the pharmaceutical industry, including managerial experience and diverse pharmaceutical experience with different dosage forms.
• Must be experienced in handling the National and International regulatory inspections USFDA /MHRA/ANVISA, preferred experience with interaction, execution, writing responses and implementation of CAPA is desirable.
• In terms of competency, you are highly result oriented with strong sense of accountability & ownership
• Ability to anticipate potential problems and risks related to manufacturing & operations, investigate solutions, and implement preventive actions.
• Must be experience in interacting with people at all levels of the organization leveraging strong communication, negotiation and influence skills.
• High on Change agility, having a flexible approach in leading by influence and collaboration
• Strong attention to details, process & system adherence, having demonstrated ability to think creatively, deal with ambiguity, and manage changing priorities.
• Excellent problem solving and decision-making skill, must possess good negotiation skill for better fitment
• High on task management & prioritization skill to manage projects according to business objectives and can pursue several objectives simultaneously.
• Excellent reading, writing and verbal communication skill to work effectively with cross-functional teams.
• Advanced knowledge in pharmaceutical production and packaging processes and experience in product formulation and performance; working experience with process technologies manufactured at the site.
• Knowledge of process, regulatory and quality documentation requirements for Manufacturing operations and compliance activities.
• Professional training obtained in the areas of regulatory inspection, compliance with cGMPs, technical submissions and requirements for monitoring compliance within the pharmaceutical industry nationally and internationally.
• In depth knowledge of national and international regulatory Guidelines associated with pharmaceutical GMP operations
• Ability to function in a fast paced, dynamic environment with multiple priorities simultaneously.
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