QA Manager Verfied

Salary Negotiable Not Specified more than 14 days ago 15-02-2018 9:34:47 PM
08-03-2018 9:34:47 PM

A leading company in the pharmaceuticals sector is looking for a thorough and efficient Quality Assurance Manager. This will be an excellent opportunity to drive oneself to great heights!

POSITION :  QUALITY ASSURANCE MANAGER

AREA          : EASTERN SUBURBS, GAUTENG

SALARY      : R 750 000 CTC - R 850 000 CTC

SKILLS & QUALIFICATIONS:

  • Must have a Completed B.Pharmacy Degree(Registered)
  • Minimum 5 years' QA/QC experience in a manufacturing environment and/or quality environment within the Pharmaceutical industry.
  • Must have Regulatory experience as well.
  • Extensive QA experience in the Pharmaceutical Manufacturing environment
  • Extensive Regulatory knowledge of MBR1/MRF1 to CTD dossiers and MCC Guidelines
  • Sound knowledge of SA GMP requirements, Industry standards and best practices sufficient to readily interpret, lead discussion and provide guidance on the relevant subject
  • Understand the requirements of the relevant Acts and regulations governing the pharmaceutical industry

 

DUTIES & RESPONSIBILITIES:

A) Quality Operations – to build a structure within the Quality Department to:

· Facilitate close collaboration with Supply to ensure timeous QA release of stock from warehouse.

· Ensure the timeous review and approval of master BMR/BPR/ Stability & Validation Protocols & Reports and QC documentation to ensure accuracy and compliance with the registered dossier and to ensure accurate manufacture of the company’s products.

· Provide Regulatory with updated data to facilitate accurate dossier amendments.  

· Train QA Pharmacists to adhere to company standards of documentation review with assurance of compliance with local and Global Quality Policies and Directives.

· Manage and be accountable for the release of batches in accordance with above.

· Manage and compile local and Global Monthly metrics reports. Investigate and compile reports on any OOT or OOS results.

· Develop strong relationships with local contract sites to assess any potential risk to the company and to report this to local Directors.

·  Be responsible and accountable for the review and approval of all contract site’s change controls and deviations, including the Regulatory impact assessment and the follow-up on ensuring the obtaining of the relevant documentation resulting thereof. 

B) Product Launch Co-ordinator – to develop a robust launch preparation procedure to manage the multiple launches expected annually:

To actively participate in each Business Unit’s (BU) launch process and responsible for implementing tracking data to ensure the release of each launch product in or before the planned launch date.

To provide the Registered product data to each Contract Laboratory to initiate the method transfer process. To aid with this process and to attend to problems that may arise to assist these sites with the knowledge required to succeed.

To timeously authorize the purchase of Contract laboratory testing equipment and reagents required.

To interact with the BU Heads to keep them informed of the status in terms of either expedited or delayed launch batch releases to assist them with accurate messaging to Customers.

To co-ordinate processes with internal and external stakeholders to reach the desired results.  

C) Quality Systems & Compliance – Responsible for initiating, reviewing and approving systems to support the Office of Global Quality (OGQ) and local GMP requirements:

To initiate and adhere to the Quality Policy.  

To review and approve Third Party Change Controls and obtain all documentation required to compile an amendment to submit to MCC. To retain Super-user status of the Trackwise CC System to drive the 3 Proposal PRs from QA, RA and Artwork and Labelling.

Stability Trials Program – to manage the local program including the capture of stability results according to monthly due date and to update the Stability Due Dates Schedule with new trials; to maintain a database for future stability results promised to MCC in submissions; to review and approve OOT or OOS results and to capture OOS on the QIR program; to review completed trials and initiate new trials to comply with GMP requirements.

Audits – to maintain the certified Auditor status to ensure compliance at TP Contractors; to assist with the pre-audit checklist, the report & follow-up on corrective actions; to train on Trackwise and use Trackwise for Audit monitoring; to perform actions resulting from our Internal Audit.

Perform actions required by the Quality Management System to include: - Compiling, reviewing and approving SOP’s using the Documentum Site Co-ordinator status already obtained - Retention sample control - Annual Product Review/ Product review – to implement the latest OGQ directives - Deviation/ Non-conformance Reports Control - to maintain a log of these - SA GMP training - to ensure Quality staff obtain annual refresher courses to maintain compliance and to roll this training out to Site personnel in conjunction with HR - ADR/AE/ PV review – to provide support to Regulatory in terms of testing or reviewing results obtained

 

Please note that if you have not received a response within 14 days of submitting your application that your application was unsuccessful. However, please keep a lookout on our website, for available positions which may be inline with your career aspirations.

 

Ref: JHB000151/S