QC Site Manager
Job purpose
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
Responsibilities
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.
Stability Program Management
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.
Specification and AMT’s
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.
Packaging Testing
Oversee the QC testing and release of packaging materials for adherence to standards.
Quality Management Systems
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.
Governance, Risk & Compliance
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
Background/experience
Minimum of Bachelors Degree in Chemistry or Pharmacy with 10 years’ related work experience
Supervisory experience
Analytical laboratory and specifications management experience
Specific job skills
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.
Competencies
Offering Insights
Creating Opportunities for Collaboration
Customer Awareness
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
Responsibilities
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.
Stability Program Management
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.
Specification and AMT’s
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.
Packaging Testing
Oversee the QC testing and release of packaging materials for adherence to standards.
Quality Management Systems
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.
Governance, Risk & Compliance
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
Background/experience
Minimum of Bachelors Degree in Chemistry or Pharmacy with 10 years’ related work experience
Supervisory experience
Analytical laboratory and specifications management experience
Specific job skills
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.
Competencies
Offering Insights
Creating Opportunities for Collaboration
Customer Awareness
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