Senior QA Officer

**Senior QA Officer**
- ** Permanent full-time opportunity** with competitive renumeration and benefits
- Work with a **high performing, agile and passionate team**
- Career growth in an expanding market, up-skilling and broad exposure

**What You Will Do**

**Responsibilities include, however not limited to**:
**Prepares batch documentation in accordance with SOPs to meet production and testing schedules by**:

- Processing shop orders & issuing batch records and test worksheets.
- Allocating expiry dates.
- Completing BPCS transactions.
- Recording and tracking department KPIs and highlighting trends or deficiencies to management.

**Closure of Deviations**

**Reviews and approves closure of deviations which have no product impact by**:

- Reviewing and approving documentation supporting minor deviations.
- Requesting further information when required to support the deviation.
- Using root cause analysis to agree appropriate Corrective and Preventative Actions.
- Referring more complex deviations to Principal QA Officer or QA Managers.

**Auditing**

**Completes assigned audits by**:

- Auditing scientific reports in accordance with SOPs.
- Performing assigned internal GMP audits, including authoring audit reports.
- Qualifying as a lead auditor
- Performing external questionnaire audits.

**Continuous Improvement**

**Contributes to continuous improvement in the department/ on site by**:

- Authoring or technically reviewing SOPs.
- Performing QA review of SOPs
- Actively coaching colleagues in other departments for improvement in documentation standards.
- Authoring reports and protocols (eg stability, APR reports).
- Performing execution review of validation studies. Actively coaching colleagues in other departments for improvement in documentation standards and compliance with QA systems.

**Product Release**

**Performs review of batch documentation to enable product release on schedule by**:

- Reviewing batch records, test worksheets and ancillary documentation for accuracy, completeness and compliance.
- Facilitating correction or completion of documentation with colleagues in other departments.
- Reconciling documentation to ensure effective document control.
- Approving intermediate batch records (i.e. antigens) for use in further manufacture.

**Prepares batch release documentation to meet export schedules by**:

- Preparing release protocols.
- Co-ordinating the approval of product release documents.
- Issuing product release documents to markets and / or internal colleagues.
- Tracking and driving completion of product release documents to achieve the export schedule

**What You Must have**

**Education**

Bachelor’s degree or higher in science-based discipline.

**Certifications**
- Qualified Auditor desirable.

**Experience**
- Demonstrated experience in a continuous improvement environment, Lean Sigma Green Belt preferred
- Experience in a GMP or similar highly regulated environment.
- Experience in a similar role in a GMP/ GLP manufacturing environment
- Excellent written and verbal communication skills and the ability to positively influence others.
- Computer skills: Spreadsheet, Word, Access, Outlook, BPCS

**What You Can Expect**
- Be critical in integrating your Quality Assurance skills for a Global leading organisation.
- Joining a **collaborative **small team of **likeminded individuals**
- Be **developed and supported** in your role

**Who we are **

We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

**What we look for** Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

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**Employee Status**:
Regular

**Relocation**:
No r