New Jobs at Aspen Pharma Group

Overview

• Manage and coordinate lab preparation and QC activities
• Manage and coordinate sampling and testing of external environment
• Provide analytical, maintenance and QC lab support
• Ensure continuous compliance of lab with GMP standards
• Ensure that products are produced, tested and stored according to the required SOP’s and documentation
• Performance management of direct reports

Skills Required

Background/experience

• National Diploma in Chemistry or Microbiology with 5 years’ related experience
• Laboratory and Good Laboratory Practice experience
• Minimum of 1 -2  Years Supervisory experience

Specific job skills

• Advanced understanding of pharmaceutical testing methods
• Knowledge of value chain and MCC principles
• Understanding of pharmaceutical manufacturing and corrective action programs
• Pharmaceutical standards and compliance requirements
• Ability to interpret and implement policies, processes and objectives

Competencies

• Interrogate Information
• Managing Performance
• Planning and Organising
• Customer Awareness

Requirements
Responsibilities

Planning and Section Management

• Provide input into operational planning of section, and prioritisation of objectives
• Provide input into, interpret and execute policies and procedures
• Provide input into and manage budgets and resource requirements for section
• Provide section staff with day-to-day direction and tasks

QC Lab Testing

• Manage and monitor compliance of QC lab testing activities to GMP, quality standards, and product specifications
• Manage and coordinate lab preparation activities according to SOPs (samples, working area(s), PPE and lab equipment)
• Prepare and implement maintenance and calibration schedules and records
• Ensure set priorities and targets are achieved, identifying constraints and solutions
• Investigate and report Out of Specifications (OOS)
• Enforce Good Lab Practice
• Proficient in Empower, Lab-X and LabSolutions usage
• Manage AMDV / AMT protocols, execution and review of AMDV / AMT outcomes
• Manage all OOS investigations and conclusions, and report to management

Environmental Management

• Manage and coordinate sampling and testing of external environment, according to SOPS and sampling plan/ schedule
• Aspen fully subscribes to the principles of Employment Equity and will make decisions in line with this ethos.

Lab Quality Reviews & Training

• Validate batch documentation approvals
• Review and approve corrections in batch documentation
• Identify and coordinate training of staff on SOPs
• Compilation of biannual trend report
• Proficient in SAP, LIMS, SLIMS, Veeva Docs, Process Compliance

Deviations Investigations

• Manage and coordinate deviation investigations and reporting
• Coordinate and initiate risk/ impact assessments and plans to address quality deficiencies
• Manage implementation of operational changes to SOPs and processes

Governance, Risk & Compliance

• Provide input to QC for improvement of risk-based compliance systems
• Monitor implementation and correct own and/or team compliance with legislation, policies and procedures;

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Description
Overview

• Management oversight of the testing and control of starting materials, consumables, components, intermediaries, bulk and finished products in accordance with Quality procedures, standards, specifications to meet planned requirements
• Develop, manage, monitor and approve Standard Operating Procedures, Methods of Analysis, specifications, protocols and reports in compliance with latest regulations
• Ensure appropriate method validations are performed and up to date
• Long term strategic planning for unit
• Manage, guide and monitor QC Laboratory activities through Team Leaders
• Staff management of direct reports and entire department (KPIs, performance reviews, disciplinary actions and other IR responsibilities)
• Risk identification and solution
• Approve all training to be implemented in the laboratory and ensure unit staff’s training are appropriately trained (initial training as well as re-training and qualification)

Responsibilities

Strategic Planning and Unit Management

• Interpret, implement and coordinate systems, processes, policies and procedures in the unit
• Provide technical and operational input into systems, procedures and policies that impact in-process control activities in value stream operations
• Perform human capital functions to ensure optimal management of unit and reporting sections
• Manage collaboration and coordination between reporting units
• Responsible to lead projects directly related to the value stream laboratories (Chemistry and Microbiology)
• Liaise, interact and provide technical guidance to QA and Production Managers
• Propose changes / improvements to processes, systems, tools and techniques
• Lead L2 and attend L3 meetings
• Make decisions regarding exceptions to policy and procedures
• Identify gaps in current policies and procedures

Financial Planning, Financial Management and Resource Management

• Develop and monitor the functional plan / budget (OPEX and CAPEX) of the value stream laboratories (Chemistry and Microbiology)
• Ensue availability and optimal allocation of resources within unit

People Management and Development

• Implement Human Capital Policies
• Identify training needs and monitor training compliance
• Participate in training, coaching and development of team members
• Develop and implement performance contracts and succession plans
• Manage conflict, disciplinary and safety issues
• Assist with recruitment

Release Starting Materials, Packaging Materials, Consumables, Intermediate, Bulk and Finished Products

• Lot release and/or rejection of starting materials, packaging materials, consumables, components, intermediate, bulk and finished goods
• Approve compliance of QC laboratory preparation and testing activities to GMP, quality standards and product specifications
• Ensure all testing is carried out as agreed / scheduled

Ensure laboratory outputs meet the agreed standard

• Approve Specifications, Sampling Instructions, Test Methods, other QC Procedure and Validation Documents
• Review and approve the documents to comply with technical, GMP and Data Integrity requirements

Analytical Method Validation and Analytical Method Transfer

• Take the lead and ensue the relevant value stream laboratory AMT activities are executed
• Manage the method transfer activities against deadlines to ensure effective and accurate compilation of raw material and finished product specifications
• Provide scientific and technical expertise and manage communication with Analytical Method Transfer partners
• Manage method validation and transfer activities against deadlines

Stability Management

• Ensure stability testing is conducted as per plan.
• Report on Stability storage capacity
• Oversee data management of relevant stability trials
• Manage the review and approval of stability results and OOS’s

Governance, Risk, Compliance to QMS and keep unit compliant to cGMP guidelines

• Ensure unit’s activities comply with current operating guidelines and policies for the organisation and function
• Monitor and correct compliance with legislation, policies and procedures to impact on the effectiveness of QC activities
• Ensue that appropriate validations are completed as per validation requirements and schedule
• Initiate and set targets and review GMP, quality and training needs
•  Ensure staff are trained on SOPs
• Request special investigations, assess outcome of these and initiate the appropriate actions to minimise risk/ instill preventative measurements
• Ensure OOS reported and corrective/preventative actions initiated Packaging Testing

Requirements
Skills Required
Background/experience

• Bachelor’s Degree or National Diploma in Chemistry, Microbiology or related fields
• Honours or Master’s degree advantageous
• 5–8+ years’ experience in a pharmaceutical QC laboratory, including
• 3–5+ years’ experience in a management role

Specific job skills

• Advanced understanding of pharmaceutical testing methods
• Understanding of pharmaceutical manufacturing and corrective action programs
• Pharmaceutical standards and compliance requirements
• Ability to interpret and implement policies, processes and objectives

Competencies

• Innovative Thinking
• Interrogating Information
• Offering Insights
• Managing Performance
• Networking