Compliance Pharmacist - Port Elizabeth, المملكة العربية السعودية - Aspen Pharma Group

Aspen Pharma Group Port Elizabeth, المملكة العربية السعودية

منذ أسبوع

دوام كامل

Job purpose

Review and approve quality related activities for value streams.
Identify and provide solutions to systematic issues – risk assessments and reviews.
Monitor compliance to GMP and statutory requirements and internal warehouse audits.
Monitor adherence to guidelines, procedures and document controls.
Deliver expected value stream targets as per business requirements.
Warehouse GMP compliance
Team and process development

Responsibilities:

Staff development

Facilitating training sessions as required related to improvements and CAPA's.
Train Warehouse Pharmacist and PMAs on SOPs in transition periods - improvements of systems
And stand-in when needed within the warehouses.

Planning and Process

Provide technical and operational input during drafting of plans and procedures specific to Unit

Process Compliance

Execute day-to-day quality activities for value streams related to department
Identify systematic technical and process issues by reviewing CAPA requests and trends
Develop CAPA plans and change incidents to address process compliance within the department
Implement operational changes to SOPs and processes, in compliance with control processes
Ensure deviationsplanned/unplanned and concessions are documented, reviewed, and analysed and recommend validation activities to be performed
Execute change control process by ensuring changes are documented, reviewed and approved.
Ensure process compliance up to date in all departments and drive close out of these.

In-process Quality Management

Product release management

Deviation management and adherence to daily, weekly targets.
Review and approve deviations, assist in investigations as required and implement corrective actions.
Maintain and update records and systems as required.
Ensure deviation owner allocation and re-allocation in accordance to prioritize.
Ensure CAPA actions are implemented deviations, CAPAs, Change Controls

Process and System improvements

Manage, review, and approve change control programs and deviations/concessions comply to standards and specifications.
Optimize processes and identify gaps in procedures.
Drive CAPA investigations in areas of focus.
Initiate formal and informal RA Risk Assessments for quality related topics for new processes.

Stakeholder management

Key interface between warehouse and support departments with main interface being with QA department.
Customer interface as needed to share information, feedback on open items, retrieve guidance and facilitate priorities.

Customer Relations

Important communication required with external customers regarding quality expectations of a product.
Implementing quality protocols which aligns with the customer.

GMP Compliance

Facilitate and support audit management in all warehouses.
Enforce and control area compliance personnel, documentation, process, product
Ensure warehouse process adherence to standards and specifications.
Enable teams and process to achieve documentation and deviation right first-time targets.
Serve as Deputy RP at Aspen distribution centre.

Requirements

Background/Experience:

Bachelor's degree B.Pharm with 3-5 years related warehouse or logistics work experience.
Pharmaceutical manufacturing or dispensing experience.

Specific job skills

Advanced understanding of the pharmaceutical manufacturing and corrective action programs
Pharmaceutical standards and compliance requirements
Ability to interpret and implement policies, processes and objectives.

Competencies