QA Compliance Manager

**Position Summary**:
**Industry**:Wholesale & Retail Trade

**Job category**:Pharmaceutic

**Location**:Cape Town

**Contract**:Permanent

**Remuneration**:Market related

**EE position**:Yes

**Brand**:Clicks Group

**Introduction**:
We are looking to recruit a Compliance Manager to work within the Unicorn Pharmaceuticals division within Clicks. This role will report to the Quality Assurance Manager/Responsible Pharmacist.

**Job description**:
**Job Purpose**:

Develop, implement, and maintain a sustainable Quality Management System (QMS) that complies with the mandatory requirements of SAHPRA under the supervision and management of the QA Manager and Responsible Pharmacist

**Job Objectives**:

- Ensure good manufacturing practice (GMP) compliance in accordance with Act 101 and SAHPRA requirements.
- Develop and maintain Unicorn Pharmaceutical’s Quality Management System (QMS).
- Assist with local and international audits.
- Ensure adherence to internal and external audit schedules.
- Promote a risk management approach within the company.
- Review and approve deviations from manufacturing, packing and distribution sites, as applicable.
- Review and approve change controls from manufacturing, packing and distribution sites, as applicable.
- Manage the corrective and preventative actions register to ensure timeous completion of actions.
- Maintain all registers and trending records of the QMS.
- Prepare the QMS performance data.
- Schedule periodic management review meetings and manage the completion of any actions originating from these meetings.
- Ensure compliance with validation program.
- Ensure compliance with the annual product review schedule.
- Ensure compliance with the stability program.
- Manage the standard operating procedures (SOPs) matrix.
- Prepare and promote GMP training.
- Manage the training matrix.
- Investigate any product or customer compliant relating to quality issues.
- Manage the change control procedure system.
- Ensure the business remains complaint with all legal and regulatory requirements.
- Manage reporting staff
- Assist with any other duties as per operational requirements within the QA department.

**Minimum requirements**:
**Job related knowledge**:

Essential:

- SAHPRA, ICH and PICs GMP guidelines (Essential)
- SAHPRA, ICH and PICs GMP quality assurance requirements and practices (Essential)
- International PICs Auditing requirements (Essential)
- Good documentation practice (Essential)

Desirable:

- Development of training modules
- Staff training

**Job related skills**:

- Computer literacy with the ability to effectively use Excel, Word and PowerPoint
- Auditing skills
- Communication skills, both verbal and effective writing
- Analytical and problem-solving skills
- Training and Presentation skills
- Planning and Organising skills
- Verbal and written communication skills
- Management and supervisory skills
- Relationship building skills

**Job experience**:

- At least 3 years quality assurance experience
- At least 5 years working experience in a pharmaceutical QA environment
- Computer literacy with the ability to effectively use Excel, Word and PowerPoint
- Preferable: history of effectively managing reportees

**Education**:

- Essential: B. Pharm Degree or a suitable Scientific or Life Sciences Degree
- Desirable: Course in GMP / Quality Assurance/ Document Management / Document integrity

**Essential Competencies**:

- Deciding and Initiating Action
- Working with People
- Adhering to Principle and Values
- Relating & Networking
- Writing and Reporting
- Planning and Organising
- Following Instructions and Procedures
- Coping with Pressures and Setbacks
- Presenting and Communication Information