Manager, QA

**Title : Manager, QA**

**JOB PURPOSE**
- To review and approve all inspection responses, change controls, deviations, CAPA and annual product review reports while overseeing and reviewing validation area processes and procedures to make recommendations for changes and/or improvements.

**Policies, Processes & Procedures**
- Recommends improvements to departmental policy and directs the implementation of procedures and controls covering all areas of Quality activity so that all relevant procedural/legislative requirements are fulfilled while delivering a quality, cost
- effective service to customers.

**Day
- to-day operations**

Supervises the day-to-day operations of Quality section to ensure that work processes are implemented as designed and comply with established policies, processes and procedures.

**Job Specific Accountabilities**
- Reviews and approves documents generated by the department, in order to provide approvals on deviations, CAPA, and annual product review reports.
- Participates in quality risk management procedures, in order to manage and maintain the day-to-day change control process for product and process related information.
- Manages the creation and revision of batch record documents to support product development and product implementation.
- Participates in developing divisional procedures and guidelines to develop responses to corporate, regulatory, and third-party audits findings.
- Interacts with all plant departments to facilitate effective change control execution in order to meet the 2 Confidential anticipated timelines.
- Leads Participate in the complaints investigation group by promoting continuous improvement through leveraging direct reports to develop effective solutions, remove obstacles, and share/implement best practices.
- Utilizes data from QA Trending for Complaints, Deviations, CAPA, and Risk Assessment to identify and escalate Product Quality risk and monitor QA metrics as appropriate.
- Reviews and investigates specific cases for quality issues at the supplier site during audits.
- Conducts gap analysis for Hikma functions actual and potential performance to facilitate harmonizing the system within the group.
- Manage the waste destruction process.
- Review and approve Validation Protocols & Reports.
- Review and approve process validation protocols & reports.

**Direction of Subordinates**
- Organises and supervises the activities to ensure that all work within a specific area of Quality activity is carried out in an efficient and procedurally compliant manner.

**Continuous Improvement**
- Contributes to the identification of opportunities for continuous improvement of systems, processes and practices taking into account ‘international best practice’, improvement of business processes, cost reduction and productivity improvement.

**Reporting**
- Prepares departmental reports of Quality timely and accurately to meet company and department requirements, policies and standards.

**Safety, Quality & Environment**
- Complies with all relevant safety, quality and environmental management policies, procedures and controls to ensure a healthy and safe work environment.

**Related Assignments**
- Performs other related duties or assignments as directed.

**QUALIFICATIONS, EXPERIENCE, & SKILLS**:
Minimum Qualifications: Bachelor’s degree in Pharmacy, Chemical Engineering, or equivalent with a master’s preferred. Minimum Experience: 6-8 years relevant experience in Quality within a pharmaceutical, industry including at least 2 years in Quality/Compliance role. At least 2 years of experience in a progressive managerial role.