Senior managers responsibilities

The senior manager responsible for validation is expected to recruit appropriately qualified and experienced staff to conduct the validation tasks and ensure that these are properly and effectively carried out. Specific responsibility for validating computer systems should be assigned to a manager who is suitably qualified — someone with relevant computer systems experience and appropriate training. 

In many organizations the senior manager responsible for GxP may also have other duties. The company must formally acknowledge and concede that these other duties do not excuse or relieve his or her responsibility for validation to the GxP regulatory authorities. In the phrase forever associated with President Harry S. Truman, the buck stops here ... 

The ORR guide refers to the need for directors and senior managers responsible for the overall policy of the company to be aware of the general objectives and benefits that may result from the use of the guidance. However, implementation is more likely to be successful if directors and senior managers are more than just aware , but demonstrate commitment to the process. 

Safety Officer The Safety Officer will be the specialist member of staff, having responsibility for health and safety within the company. He or she will report to the senior manager responsible for health and safety. 

Does the Quality Assurance Coordinator have clearly defined authority and responsibility and does he report directly to a senior manager ... 

The coordinator should have authorities and responsibilities that are defined and documented, for example, in the job description. He or she should report directly to a senior manager in quality matters even if reporting to a lower level on other duties. 

Given that multiple contractor and subcontractor organizations could be involved in work activities, senior management should address any misunderstandings concerning specific operational responsibilities and accountabilities that could cause problems in the administration of site-specific programs. 

Span of control is most likely to be a concern among those reporting to senior management. However, if top level responsibility for PSM and ESH is divided among several managers, it can arise at this level as well. For example, occupational safety may fall under human resources, while environmental is within the legal department. 

Similarly, security should be a function of senior management, and it should rank alongside other management responsibilities. This will help to demonstrate that the company is committed to a security program that appropriate resources are allocated and those protective systems and procedures are properly used and maintained. 

He will be responsible to the chief executive and will achieve the objectives laid down by senior management. 

While the overall policy responsibility for health and safety rests with senior managers, all employees within the organization, irrespective of their duties, have some degree of responsibility for carrying out the policy. Where appropriate, nominated persons with specific responsibilities for health and safety should be named with a summary of their responsibilities defined. It follows that there should be a procedure established whereby deputies are available during the nominated person s absences. 

Structure and responsibility. These are concerned with ensuring that there is a senior manager with overall responsibility for the programme and that the responsibilities of other staff are clearly identified and communicated. These individual responsibilities should fit with the overall policy and objectives. 

The supervisor, manager, or engineer responsible should be reminded when a test or inspection is due, and senior managers should be informed if it has not been carried out by the due date. Test and inspection schedules should include guidance on the methods to be used and the features that should be inspected. For example, if the time of response is critical, it should be checked. 

The organization s incident investigation management system should specify the team leader s responsibilities and authority. Upon selection of the team leader, the leader and senior management should review and agree on all assigned responsibilities. The agreed responsibilities should... 

Pharmaceutical companies frequently establish a committee of senior management to authorise the first study of a NME in humans, the review and approval generally being a prerequisite for submission to the external lEC. However, as stated in Section 4.3.4, the clinician responsible for the first study in humans must be personally satisfied that the preclinical data, relating to efficacy and safety, justify administration to man. A useful test is for the physician and other responsible personnel to ask themselves Would 1 be prepared to volunteer for this study and would 1 be happy for a loved-one to do so ... 

Incident Command System (ICS) An ICS is an organized approach to control and manage operations at an emergency incident. The OSHA Hazardous Waste Operations and Emergency Response regulations (29 CFR 1910.120 (q) (3) (iii)) require that and ICS be implemented by the senior emergency response official on the scene. The reader should refer to Appendix 6, of the OSHA rule for more information on ICS. 

Resources Sufficient resources should be provided to create a robust quality system that complies with the GMP regulations. Senior management or a designee should be responsible for providing adequate resources. 

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