Job Title: Quality & Technical Manager (Permanent) (*)
Department: Quality, Technical & Compliance
Reports to: Senior Technical Manager / Head of Quality
Line Report: Assistant Quality & Technical Manager
MAIN PURPOSE OF ROLE:
- External Audits 35%
- Complete QTAs 30 %
- Complete Stability Report Reviews 10%
- Complete internal and external “For Cause Audits” & Leading Internal Audits Bi- annually 10%
- Complete elemental impurities risk & excipient risk assessment 10%
- Tracking completion of all CAPA relating to Customer audit of Waymade & Internal Audit audits CAPAs 5%
- External Audit of all product formulations (Solid dose, APIs, Sterile, Liquid formulations).
- Quality and technical agreements to be completed in order of risk and engage with stakeholders to complete new / updates in a timely manner.
- Take a lead in agreeing with stakeholders & tracking to completion of all CAPAs relating to Customer audit of Waymade & Internal Audit audits CAPAs.
- Lead timely discussion of OOS with other Technical Managers and plan appropriate timely face to face or telecon discussion with all stakeholders.
- Complete assigned internal and external audits
- Lead Auditor for Internal Audits on a Bi-annually basis
- Support internal staff auditor development.
- Evidence for completion of assigned elemental impurities risk & excipient risk assessment
- Evidence of completion of assigned Quality and Technical Agreements to eliminate any overdues.
- Evidence of tracking & follow up on all outstanding assigned Quality and Technical Agreements.
- Evidence of completion of assigned internal and external audits.
- Evidence of Leading reviews of OOS and RCAs in a timely manner and timely escalations to HOQ/QP as required.
- Evidence of timely working with relevant stakeholders to achieve timely completion of all CAPAs relating to Customer audit of Waymade & Internal Audit audits CAPAs.
- Evidence of successfully leading of internal audits on a bi-annual basis to cover all areas of the business.
- Evidence of timely completion of Adhoc and other tasks as assigned.
- Completion of assigned elemental impurities risk & excipient risk assessment does not hold up batch release.
- To maintain a professional standard always.
- To be punctual, polite and courteous to Waymade Group customers and to all staffs always.
- To ensure compliance to all the Company’s Policy and Procedures, i.e. Health and Safety, GXPs, SOP and Dress code etc.
Before you complete this form
Please download and complete the Waymade job application form using the link below. The completed application must then be attached to this form.
Download the Waymade job application form