Senior QA Associate (Shift Role)

Key Responsibilities:

* Perform all activities in compliance with safety standards and SOPs

* Observe and provide real-time Quality oversight and support for Packaging unit operations.

* Perform Finished Pack Quality audits- "Pack checks", on each finished labelled and packaged lot during batch operations.

* Decision maker on classification of defective units found during combination product assembly, and labelling and packaging processes in accordance with the on-site defect manual

* Provide Quality support for triage of atypical events during production. Guiding the cross functional work centre team on the rationale for continued operation and appropriate next steps to ensure Product Quality requirements are met

* Perform Quality oversight of minor deviations, ensuring compliance with appropriate documentation.

* Review/approve production batch records, and associated documentation in preparation for Qualified Person disposition activities.

* Provide training and advice to staff in order for them to perform their desired functions.

* Write, review, and approve Standard Operating Procedures in accordance with Company Policies.

* Support continuous improvement and Operational Excellence initiatives

* Participates in Customer complaint investigations by virtue of completion of complaints based retrospective batch record review, and also as a team member in Cross functional Root cause analysis investigations

* Any other tasks/projects assigned as per manager's request.

Basic Qualifications & Experience:

* University degree. Engineering or Science related discipline preferred.

* Relevant experience (4 yrs +) working in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the requirements of the role.

Preferred Qualifications & Experience:

* Experience in the QA department for 2+years

* Excellent written and verbal communication skills

* Experience working with dynamic cross-functional teams and proven abilities in risk-based decision making

* Strong organizational skills, including ability to follow assignments through to completion

* Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Deviation investigations

* Experience working with combination products or devices in packaging-related or complaint-handling activities

* Knowledge of applicable Regulatory requirements, and ability to evaluate compliance issues

* Operational Excellence experience

Shift Pattern is as follows:

24/5: 12 hour shifts, 3 cycle (ie repeats every 3 weeks)

* Shift A example below:

* Week 1: Day- Monday & Tuesday, Off Wednesday, Night -Thursday & Friday

* Week 2: Off Monday & Tuesday, Days Wednesday - Friday

* Week 3: Nights Monday-Wednesday, Off Thursday & Friday