QC Site Manager - #353870
Aspen Pharma Group
Date: 2 weeks ago
City: Port Elizabeth, Eastern Cape
Contract type: Full time
Job Purpose
Planning and Unit Management
Skills Required
- 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
Planning and Unit Management
- Provide technical and operational input into processes, procedures, and policies, and monitor operational objectives and plans.
- Make decisions regarding exceptions to policy and procedures.
- 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.
- Identify training needs of QC 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 specification and method transfer activities against deadlines to ensure effective and accurate compilation of raw material and finished product specifications.
- 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 minimize risk/ instill preventative measurements.
- Ensure OOS reported, and corrective/preventative actions initiated.
- Oversee the QC testing and release of packaging materials for adherence to standards.
- Oversee the maintenance of database security, access levels and validated state of database.
- Initiate and manage projects for upgrading SLIM, perform validation upgrades & track licenses.
- Ensure unit’s activities comply with operating guidelines and policies for the organization and function.
- Monitor and correct compliance with legislation, policies, and procedures to impact on the effectiveness of QC activities.
Skills Required
- 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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