Maintain and develop Compliance, Quality Systems. Assist in driving continuous improvement

• Review of Aspen Group policies and procedures and alignment with local processes. Ensure training is carried out and systems are used according to procedures.

 Change Control

• Manage change control system.
• Liaise with regulatory personnel for the regulatory impact assessment.
• Liaise with supply team on artwork change and implementation timelines. Ensure the verification of artwork change is completed.

 Deviation Management

• Review and communicate all deviations generated by the manufacturing sites for MAH approval.
• Raise and investigate internally raised deviations and ensure completion in timely manner. Raise and investigate internally raised deviations and ensure completion in timely manner.

 Artwork Changes Coordination

• Working closely with the regulatory team, Global Team, artwork studio and markets to manage the changes in the system.
• Liaise with supply team on artwork change and implementation timelines. Ensure the verification of artwork change is completed.

 Product Quality Complaints

• Ensure product quality complaints are registered and closed out in a timely manner.
• Liaise with the Aspen Global Team and Distributors to address and coordinate all market complaints.
• Provide customer complaint response letters to all distributors.

 Product Quality Review and Stability Program

• Maintain a schedule for periodic PQR and Stability for all marketed products to distributor countries.
• Ensure up to date Stability reports are maintained on file to ensure the necessary coverage of Aspen products.

 Corrective and Preventative Actions

• Maintain the CAPA register resulting from self-inspections, deviation, product quality complaint and recall.
• Ensure actions are implemented and closed out timeously.

 Qualifications and Requirements

• Degree holder in science related field.
• 4 - 7 years’ QA experience within the Pharmaceutical Industry. At 2 – 4 years in artwork management is desirable.
• Excellent attention to detail.
• Excellent communication skills both verbal and written.
• Good understanding of PIC/S GMP standard.
• Strong focus on and commitment to process improvement.
• Willing to participate in ad hoc projects and assignment as required.
• Demonstrate a high standard of teamwork and collaboration.

With a 160-year heritage, Aspen is a global specialty and branded multinational pharmaceutical company with a presence in both emerging and developed markets.  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 medicines.

Aspen is a dynamic organization 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.  Interested parties please apply in full resume with current and expected salaries to [email protected].

Our Purpose….. To improve the health and quality of life of patients.