RA Quality Officer– South Africa ( 3 Months Contract, On-Site) at Aspen Pharma Group

Description

Company Description

We are a global specialty and branded pharmaceutical company, improving the health of patients across the world through our high quality and affordable medicines. Active at every stage of the value chain, we are uniquely diversified by geography, product and manufacturing capability.

Aspen is a dynamic organisation built on entrepreneurial strength and forward-thinking minds. We attract high performing individuals who are passionate about their career and have a desire to exceed expectations. At aspen, not only do we source for the best talent but we also provide a host of opportunities for continuous development.

The Group’s key business segments are Manufacturing and Commercial Pharmaceuticals comprising Regional Brands and Sterile Focus Brands. We have approximately 9 100 employees at 69 established offices in over 50 countries and we improve the health of patients in more than 150 countries through our high quality, affordable

MAIN DUTIES

FINANCIAL

• Effective utilization of resources to keep processes cost effective

CUSTOMER

• Display a professional attitude when responding to customers
• Propose, develop, and update methods to improve customer services
• Effective liaison and communication with internal and external customers

QMS – UNDER SUPERVISION OF THE QUALITY PHARMACIST / LEAD

• Providing support for QMS activities, including change controls, GMP deviations, technical agreements, quality risk assessments, customer complaints, PQRs, self-inspection and external audit reports, and SOPs.

Assist with change controls and deviations in line with SOPs, standards and product quality and specifications, including

• Timeous initiation on Change Management system
• Assignee role on change control system which includes Co-ordinating and completing the evaluation and/or pre-implementation requirements of the change and following up regularly and ensuring the change control record is completed within the required timeframe
• Reviewing and following up on action items and tasks
• Change controls comply with SOPs, standards and specifications
• Assist in the customer complaints process – logging, review, follow up, customer response and any other duties as assigned

Documentation Management:

• Review and update of required SOPs/ Work Instructions/ SFs / Templates for QMS functions
• Compiling, updating, reviewing documents on the Document Management System
• Verify good document practice as per SOP and regulation
• Documents and records are logged, updated and maintained as per SOPs and schedules
• Query Documents

Support and Involved in:

• Vendor management process, including audit schedule and matrix, scheduling audits, assistance in compilation of audit reports, follow up on reports and CAPAs, drafting TQAs, circulating for review, implementation and distribution
• Internal self-inspection process, including audit schedule, participation in self-inspection, compilation of audit reports, follow up on reports and CAPAs
• Annual product quality reviews, including schedule, requesting and collating data, compilation and follow up
• Waste management – assisting in management of sample requests, sample destruction and related tasks
• Assist with the Short-dated stock release process, blocked stock notifications, co-marketing arrangements, material listing verifications at internal and third party distributors / wholesalers
• Permit application process for SA and SADC
• Complete forms as required
• All compliance and audit checks are completed
• Systems are updated and maintained
• Site Master File - Assist in compilation and updating of the Site Master File

QSMR

• Participate in QMS monthly and annual reviews
• Assist in the compilation of the QSMR under the guidance of the Quality Pharmacist and the Quality Lead

GENERAL

• Any other duties as assigned by line manager / HOD
• Adhere to agreed Key Performance Indicators (KPIs) 
• Support the continuous development and improvement of the Quality function while upholding Aspen core values 
• Adhere to Company Health & Safety procedures 
• Provide systems and SOPs implementation support for identified Woodmead Departments/Divisions
• Maintenance of trackers and databases
• Working with all members of staff to maintain and develop the positive progressive culture within Aspen.
• Observing and complying with Good Manufacturing Practice (GMP), Good Wholesaler Practice (GWP) and Good Distribution Practice (GDP). 
• Observing and complying with company Standard Operating Procedures (SOPs).
• Active collaboration with the local Regulatory and Operations teams to ensure the appropriate flow of information and decisions
• Utilise systems, data bases and trackers to provide accurate information to internal and external customers on request 
• Adhere to deadlines/due dates
• Escalate to line manager all possible delays and critical issues

Requirements

LEARNING AND GROWTH

• Training and development identified and planned with the line manager
• Training is implemented according to ongoing personal and team development plans
• Up-skilling and multi-skilling are co-ordinated in line with staff development

KNOWLEDGE

• Understanding of pharmaceutical quality
• matters, legislation, regulations, and
• guidelines. 
• Having attended a quality or regulatory
• course would be advantageous.
• Computer skills in MS Office suite and Adobe Pro require.
• Experience with electronic quality management systems 

SKILLS AND ATTRIBUTES:

• Results oriented
• Systems thinking
• Focused
• Cooperation
• Proactive
• Responsibility & Accountability
• Resilience
• Informal communications skills
• Active listening skills
• Flexibility and tolerance for ambiguity
• Transition management
• Capacity for resistance to stress
• Perseverance and tenacity
• Understands Aspen story
• Aspen knowledge
• Optimism
• Passion
• Curiosity/learning agility
• Self-awareness
• High standards
• Effective planning and organisation skills
• Customer focused – understands the needs and priorities of customer
• Accuracy and attention to detail
• Manage evolving deadlines effectively with regular feedback, updates
• Integrity 
• Work ethic  
• Ability to meet deadlines 
• The ability to communicate effectively (written and verbal) is essential
• Sense of urgency
• Information Seeking
• Service orientation
• Initiative 

EDUCATION & EXPERIENCE: 

• Matric
• Qualification in Quality, pharmacy or medicine is preferable
• Minimum 3 years’ experience in Quality in a GxP-accredited pharmaceutical environment, preferably in an MA Holding, Distributor, Wholesaler or Manufacturing facility
• Experience in Quality Management Systems required