Senior Sterile Auditor
- 3300, Kinsale Rd, Ballycurreen, Cork Airport Business Park, Co. Cork, T12 XN72, Ireland, County Cork (IRL)
- Negotiable
- Permanent
- Start date: 24 Jan 22
- Ref: 5081683
- auditing
- sterile
- pharmaceutical
Senior Sterile Auditor
The Company:
The company is a leading international supplier of generic pharmaceutical drugs
The Role
As a member of the Supplier Quality team the Senior Sterile Auditor will be responsible for assisting the Supplier Quality Manager in ensuring that licensed pharmaceutical products are manufactured, tested and released in compliance with cGMP, US FDA and other applicable regulations. The key function of this role is to minimise the risk by ensuring a high level of compliance is being adhered to for outsourced work. The post holder will be the lead for auditing and associated activities in our contract manufacturer sites in India, China and other territories on a regular basis specifically associated with sterile manufacturing facilities; this will require travel to these regions approximately 40% of time.
Responsibilities
- Be the SME and technical resource for the oversight of sterile manufacturing facilities including defining the approach to inspection of sterile FP facilities for vials and syringes
- Lead and conduct quality inspections of outsourced manufacturing facilities, including, but not limited to, sterile finished product manufacturing facilities and solid dose finished product manufacturing facilities to ensure compliance with cGMP and US FDA regulations.
- Lead and conduct Responsible Sourcing inspections of outsourced manufacturing facilities as per company guidelines.
- Lead and conduct quality inspections of other third-party service providers such as packaging sites, API manufacturing facilities, contract laboratories and any other audits that may be required to suit business needs.
- Responsible for the maintenance of Quality agreements from initial negotiation and the updates of these documents on an ongoing basis.
- Responsible for generation and maintenance of supplier scorecards.
- Perform supplier quality risk assessments and regulatory oversight.
- Compile inspection reports to include findings, corrections and process improvements.
- Track corrective actions and planned action agreements from inspections to closure.
- Participate in continuous evaluation and improvement of all quality aspects at manufacturing sites with particular emphasis on process systems and QMS.
- Carry out compliance due diligence exercises
- Assist in ensuring compliance policies are managed correctly and efficiently and provide recommendations and direction to relevant parties as necessary
- Keep the Management team and colleagues updated on issues and actions which impact the business
- Participate in regular team and group meetings
- Be flexible within the Quality function to meet the needs of the growing business; using technical expertise, skills, knowledge and experience as required.
- Provide technical and GMP direction and training to colleagues
