- Lead the Centralized Quality Control projects and services, including Stability Management, Investigations, Packaging Testing, Quality Systems and maintenance of laboratory instruments and equipment.
- Manage and guide the unit through team leaders.
- Performance management of direct reports and unit
- Interpret, implement and provide technical and operational input into processes, procedures and policies, and monitor operational objectives and plans.
- Make decisions regarding exceptions to policy and procedures.
- Plan, track and collaborate all QC central activities to ensure objectives are met.
- Identify gaps in current policies and procedures.
- Build and maintain relationships with internal/ external stakeholders.
- Provide input into the financial plan and manage budget.
- Ensure availability and optimal allocation of resources within unit.
- Perform HR functions to ensure optimal management of unit.
- Propose changes/improvements to processes, tools and techniques for continual improvement and regulatory compliance.
- Identify training needs of QC Central staff.
- Report on storage capacity, calibration, validation and maintenance of stability chambers
- Lead a comprehensive stability study program.
- Oversee data management of local and international stability trials for all Aspen products, and 3rd party products where required.
- Manage the review and approval of stability results and OOSs.
- Manage the Stability Forum and present stability OOS alerts, outcome of technical and analytical investigations, and proposed solutions to product stability failures.
- Manage new specification and methods activities against deadlines to ensure effective and accurate compilation of raw material and finished product specifications.
- Manages routine specification updates based on evaluation and interpretation of current vs latest Pharmacopeial routine requirements.
- Provide expertise and manage communication in order to resolve specification queries from internal and external customers.
- Request special investigations, assess outcome of these and initiate the appropriate actions to minimise risk/ instil preventative measurements.
- Manage the development and implementation of method validation, verification and transfer activities in support of technical transfers according to set timelines.
- Ensures the completion of process validation testing in support of technical transfers
- Ensures that methods are in line with regulatory requirements.
- Provides technical support to the QC Laboratories
- Manage scientific investigations across site laboratories.
- Develop systems and processes for conducting laboratory investigations within GMP environment.
- Provide assistance to the QC laboratories with problematic laboratory investigations.
- Manage all laboratory equipment maintenance, calibration, and compliance activities and adherence to specified timelines.
- Ensures that faulty lab equipment is repaired within set timelines and according to policies and procedures.
- Ensures new equipment is qualified and commissioned within set timelines.
- Assist and supports the QC laboratories with equipment trouble shooting.
- Oversee the QC testing and release of packaging materials for adherence to standards.
- Equipment Calibration and maintenance
- Manage all laboratory equipment maintenance, calibration, and compliance activities and adherence to specified timelines.
- Ensures that faulty lab equipment is repaired within set timelines and according to policies and procedures.
- Ensures new equipment is qualified and commissioned within set timelines.
- Assist and supports the QC laboratories with equipment trouble shooting.
- Equipment Calibration and maintenance
- Manage all laboratory equipment maintenance, calibration, and compliance activities and adherence to specified timelines.
- Ensures that faulty lab equipment is repaired within set timelines and according to policies and procedures.
- Ensures new equipment is qualified and commissioned within set timelines.
- Assist and supports the QC laboratories with equipment trouble shooting.
- Minimum of Bachelors Degree in Chemistry or Pharmacy with 10 years' related work experience
- Supervisory experience
- Analytical laboratory and specifications management experience
- Expert knowledge and advanced understanding of packaging testing, and raw material and finished product analysis.
- Advanced understanding of pharmaceutical and pharmacopeial testing, ICH stability guidelines and regulatory body guidelines for specifications and methods of analyses
- Advanced understanding of pharmaceutical manufacturing and corrective action programs, standards and compliance requirements
- Ability to interpret and implement policies, processes, and objectives.
- Offering Insights
- Creating Opportunities for Collaboration
- Customer Awareness
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QC Site Manager - Port Elizabeth, المملكة العربية السعودية - Aspen Pharma Group
وصف
Job purpose
Responsibilities
Planning and Unit Management
Stability Program Management
Specification Management
Technical Transfer management – Analytical
Laboratory investigation management
Equipment Calibration and maintenance
Packaging Testing
Quality Management Systems
Governance, Risk & Compliance
Requirements
Skills Required
Background/experience
Specific job skills
Competencies