Qc Manager

2 weeks ago

Durban, South Africa Cipla Full time

**Job Purpose**
- To ensure that Quality Control functions are performed in accordance to Regulatory guidelines
- To effectively manage the Quality Control department to ensure that service level agreements with other departments are met
- To effectively plan, organize, lead and control the activities of the Chemistry, Microbiological, Packaging and In-Process laboratories and to ensure that the financial, safety and health, environmental and quality standards are achieved
- To provide technical service to problems arising in the plant
- To continuously review business systems, methods, and procedures to ensure effective and cost efficient administration of the QC department
- Keeps abreast of developments by research, literature and attending symposium

**Key Accountabilities**

**Management of the QC Function**
- Tests incoming raw materials and packaging components to defined specifications
- Tests intermediates and finished products to defined specifications
- In both cases the job holder must balance the rapid throughput needs of the business with its requirement for ensuring quality and meeting obligations
- Rapid decisions are constantly required, but with a high level of integrity and professionalism and to meet the legal requirements
- Develops, Implements and maintains systems for calibration of equipment and control of reference standards
- Release or rejects raw materials/packaging materials based on compliance to specifications
- Sampling of raw materials/packmats/ intermediates/bulk/finished packed product
- Approve specifications for above materials to ensure quality requirements are defined and meet current requirements
- Assesses and documents quality of products to specifications and reports results to QA
- Reports timely all non-conformances (Out of Specification/Out of Trends/Deviation) to QA and leads the investigations.

**Efficiency**
- Allocates the QC resources to best effect and ensures tasks are completed within specified timescales
- To prepare the laboratory budgets (capital and overheads) and to control expenditure within the approved budgets

**Analytical Improvements**
- Ensures the development of improved analytical test methods which utilize new technology or methodology improvements to improve the throughput speed or reliability of the methods
- Decides the suitability of the method, Tech Transfer responsibility
- Sets up and implements a reduced testing programme once justified/approved as above.

**Technical Support**
- Provides support to quality control and manufacturing for resolution of analytical and quality related problems
- Reviews and approves all QC specification, investigations and reports
- Implements activities to prevent recurring of OOS and OOT attributed to QC function.

**Employee Management and Development**
- Sets work objective, reviews performance and ensure the training, development and motivation of his team in order that they are competent in the analytical procedures before testing of any materials so it functions effectively and that all are able to realize their potential
- Training in basic laboratory techniques, complex analytical techniques and computer systems
- Provide ongoing training for staff/subordinates

**Validation**
- Ensures that all test methods are validated before use in the laboratory
- Is a member of the validations team for all manufacturing processes and procedures

**Manufacturing Development Measures**
- Provides quality performance statistics which form trigger for continuous improvement of the quality system
- Active input and involvement in problem solving through participation in the CI programme

**Technology Transfer**
- Provides input on all quality control aspects
- Ensures that stability studies are carried out on the first 2 production batches of all new products so that product quality is assessed throughout its shelf life
- Provides and interprets the stability reports and makes recommendations to shelf life
- Stability ensures that rolling stability studies are carried out on existing product per current SOP

**Audits**
- Assesses the quality control systems in place for compliance through self audits of the various laboratories
- Evaluates and reports on audits, implements and follows up on corrective action taken
- Is a member of the team for assessment of quality systems compliance
- Assists in external audits for contract laboratories

**Business Operating System (Syspro/SAP)**
- Updates relevant QC related data
- Ensures release of raw materials, packaging components and WIP via the system

**Master Documents**
- Generate and implements SOP’s for the Quality Control function
- Develops and approves raw material, finished product, packing materials monographs for new or revised.

**Skills & Knowledge**

**Educational qualifications**:
**Relevant experience**:
5-8 years Quality control laboratory experience in pharmaceutical, chemical or allied industries, especially analytical techniques (HPLC and GC)

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