ISO 9001 - Mehsana

ISO 9001 - Mehsana

2 Nos.
43543
Full Time
2.0 Year(s) To 5.0 Year(s)
2.00 LPA TO 6.00 LPA
Production / Quality / Maintenance
Pharma/Biotech/Clinical Research
Job Description:
  • Understanding the needs of interested parties: Clause 4.2 requires that the company determine who the interested parties of the QMS are, such as customers and suppliers, and determine what the requirements of these interested parties are. Performing this task and keeping the information up to date is one task that is often within the job description of the quality manager.
  • Establishment and continual improvement of the QMS processes: Once the company processes and their interactions are determined and implemented per clause 4.4, this process flow mapping needs to be maintained in order to track the continual improvement of the QMS. Maintaining an overall process integration flow is one activity that many quality managers perform.
  • Customer focus and product conformity: When looking at customer focus in clause 5.1.2, there is a need to determine the risks and opportunities that can affect product conformity. Managing the risks and opportunities for product quality could be one of the tasks of the quality manager, and is further elaborated in clause 6.1 of the ISO 9001:2015 standard.
  • Responsibility and authority for the QMS: In Clause 5.3 there is a need for top management to assign responsibility and authority for many activities of the QMS such as ensuring QMS conformance, promoting customer focus, and reporting on QMS performance. A quality manager has been the traditional employee to be given this responsibility.
  • Quality objectives: Monitoring the quality objectives (clause 6.2) that have been established and reporting this to top management is another traditional role of the quality manager. Having one person focus on the management of this important activity is a good idea to provide focus and direction.
  • Internal and external communication: Communicating with customers (clause 7.4) on quality matters is most easily done if you have one point of contact such as a quality manager. This way your customers know the best person to call to get answers when problems occur, rather than taking time to find the right person. Likewise, it is best if your employees receive QMS information from one source. A quality manager is ideal to fill these roles.
  • Release of products and services: In section 8.6 the requirements ask that you determine the planned arrangements to verify the products and services and indicate that the products and services have successfully met the requirements. The people who perform these inspections often report to a quality manager, so the quality manager would direct and control these operations within your company.
  • Internal audit planning & management: Of all the requirements in clause 9 for performance evaluation, the requirements for managing the internal audit most easily fit into the traditional role of a quality manager. Having one overall person responsible for this activity can once again focus the resources to perform the auditing role within the company. The quality manager can provide this focus, direction, and control for QMS audits.
  • Nonconformity and corrective action: Having a quality manager in charge of the nonconformity and corrective action processes per clause 10.2 is another traditional role of the quality manager. With one owner, these processes that are used throughout the organization can be better controlled so that one process is used everywhere and best practices are incorporated by everyone
Company Profile

A company is a manufacturing & distribution company based in India with more than 25 years of experience in the production of --- packaging --- for pharmaceuticals and medical device industries.

A company also distributes other packaging --- to give one-stop solution for all packaging needs for pharmaceuticals and medical device industries.

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