QA Manager (Pharmaceutical)

SUMMARY:
Company based in Roodepoort is looking for a suitable candidate to provide support relating to the implementation, maintenance, monitoring and continuous improvement of Quality Management System (QMS) at Technikon Laboratories (Pty) Ltd in line with SA GMP guidelines, PIC/S guidelines and requirements and other standards where applicable. QA batch release of manufactured products

POSITION INFO:

Duties:

• Manage the QA Batch Release process

Ensure that all documentation is completed on time and in full (OTIF) to support the timeous release of products.

Coordinate the review of batch documentation for manufactured and or packed products on behalf for Technikon.

Batch Release on behalf on Technikon Laboratories (Pty) Ltd. 

• Compiling and reviewing Quality documentation and SOP’s

Writing, reviewing and approving Standard Operating Procedures (SOPs). 

• Management of customer and product queries and complaints

      Coordinate technical queries and product investigations.

             Responding to enquiries in a timely manner, giving advice on ‘specials’ quality requirements in order       

              to maintain the company''s reputation for customer service and technical acumen. 

• Training Management System

       Keeping abreast with current GMP standards, requirements and industry best practices.

Conducting GMP training or delivering internal training e.g. GMP and Hygiene Induction training when necessary.

• Ensuring good relations and communications with all members of the team and responding politely and in a timely fashion to internal and external customers.
• Working with all members of staff to maintain and develop the positive progressive culture within The Specials Laboratory.
• Observing and complying with company Health and Safety Policies.
• Observing and complying with company Standard Operating Procedures (SOPs).
• Undertaking any other duties, either for this department or any other department within the business, which may be requested by the Line Manager, for which training and/or an explanation has been provided and understood.

 ·         Support, maintain and manage the QMS system with respect to following:

Technical agreements, quality risk management, PQR’s, self-inspection supplier audit reports, and SOPs.

Conducting/assisting with internal self-inspection audits

Participating in regulatory inspections.

Observing and complying with Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP)

Change management process - Implement and manage change via a change control system. Ensure that all changes are captured, assessed and trended appropriately.

CAPA management system so that such CAPA’s are raised, managed and trended periodically. Ensure that there is a system in place to assess CAPA effectiveness.

Monitor and trend CAPA’s associated with unacceptable risks to the organization

 ·         Ensure that a Training Management System is in place

Implement a training management system such that all GxP personnel within the organisation are adequately trained to perform their tasks.

 ·         Coordinate the Implement and management of an effective Document Management System (DMS)

Implement a DMS in line with GxP requirements and one that meets the operational requirements of the organisation. Ensure that the DMS allows for the swift creation and approval of master documents in an efficient and timeous manner.

 ·         Quality Management Reviews

Support quality management preparation reviews for internal discussion and senior management

  Management Responsibilities

• Direct Reports: 3

Minimum Qualification and Experience required

• Tertiary qualification; B Pharm
• Registration with the SAPC as a Pharmacist
• Knowledge of QMS in the Pharmaceutical Industry
• At least three years experience in quality or production.
• Syspro

• Knowledge of Quality Management Systems

  Knowledge of Training Management System

  Knowledge of Documentation Management System

  Knowledge of Audit Management

  Knowledge of Quality Risk Management

  Knowledge of CAPA Management

  Knowledge of the Regulatory Environment in SA; requirements, regulations and guidelines

Should you not receive a response within 10 working days, please consider your application as unsuccessful

NB! This job is now closed. You can apply for other jobs by uploading your CV.