Quality Operations Manager
PCI Pharma Services
21 days ago
The role is to implement and execute tasks relating to day to day Operational Quality aspects. The role entails taking responsibility for Quality matters around process and documentation. The role also acts as the key point of contact with customers in relation to quality issues.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
* Manage the generation and review of all batch manufacturing records within the business unit as part of production start-up and post batch review activities, ensuring agreed timelines are met.
* Drive the update, review and maintenance of all forms and records related to quality activities in the facility.
* Review all deviations and investigations arising from the process or related to the products packed in the business unit and respond to customer queries related to product investigations.
* Maintain compliance with GMP and customer expectations as defined in Quality Agreements.
* Schedule and manage the activities of the quality operations team:
* Sets performance objectives/goals for quality operations team and regularly evaluate employee's performance.
* Monitor and track the performance of batch file completion and evaluate performance against agreed indicators.
* Ensure that ongoing inspection and review of all logbooks and off-line documentation used is performed.
* Manage and perform GEMBA walks on a frequent basis to monitor the housekeeping practices in the area and to evaluate GMP compliance.
* Ensure that product inspections are performed, results comply with acceptable quality levels and investigations initiated when necessary.
* Direct quality activities within the incoming goods receipt area.
* Participate in regular meetings with customers to ensure current business needs are fulfilled and support continuous improvement projects including new product introductions.
* Identify and support opportunities for improving internal processes and or procedures.
* Become an area Subject Matter Expert on Quality matters relating to the process in order to assist in Customer and Regulatory audits as needed.
* Undertake such tasks and to manage specific or ad hoc projects as and when required to meet department and business needs and within the scope of the job-holder's capabilities.
* Demonstrable experience of packaging and processing activities within the pharmaceutical or medical device industry.
* Experience of quality critical activities within packaging and facility management.
* Experience in the review of deviation investigation and use of applicable investigation tools.
* High level knowledge of packaging equipment, facilities and processes.
* Good knowledge of Quality Assurance inspection requirements.
* Good working knowledge of cGMP.
* Continuous Improvement methodology.
* Risk Analysis principles and associated methodology.
* Knowledge of ICH, GAMPs, Annex 11 and Eudralex guidelines.
* Formally qualified to Degree level in an Engineering or other scientific discipline.
* Received formal training in cGMP requirements within Quality Assurance role.
* CI Green belt standard or equivalent.