An opportunity has become available for a suitably qualified and experienced Responsible Pharmacist in Midrand. The ideal candidate will provide independent quality oversight of the warehouse operations to ensure that all products meet the quality that customers expect, and local regulations require.
As the central quality contact for the organisation, the Responsible Pharmacist will advise, decide, report, consult and escalate quality and pharmacovigilance matters relating to products distributed to the appropriate affiliate management, Quality Leader or Corporate management when needed. Perform the duties of Responsible Pharmacist for the Warehouse and operations to ensure that the operation legally complies with the requirements of the Medicines and Related Substances Act 101 of 1965, Pharmacy Act 53 of 1974 and Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act 36 of 1974.
- Assist affiliate management and quality leadership in assuring that all operations of the warehouse comply with applicable GxP and other applicable company quality standards and local regulations.
- Responsible for product quality related matters, escalate any local product quality related issue to quality leadership and the affiliate management, and collaborate in any local action to be taken as a result of that (i.e. recall, counterfeit etc).
- Raise Notifications to Management when required.
- Work closely with the business to ensure proactive identification and resolution of issues.
- Ensure that distribution, product release and warehousing is compliant with company standards and external regulatory requirements.
- Implement and monitor product quality systems and local Quality Manual in the warehouse.
- Ensure that an audit plan and Quality agreements are in place covering warehouse processes and service providers.
- Demonstrate continuous improvement and minimize risk by a routine self-assessment, corrective and preventative actions, and use of a Quality Plan.
- Ensure a training program for employees with quality duties and responsibilities is in place.
- Halt hold or quarantine product status as required.
- Ensure that there is a system in place to manage the disposal of rejected products in compliance with company and local regulatory standards.
- Responsible for Quality operational tasks: Deviations management, Change control management, procedure reviewer and approver and maintenance of the Quality Plan.
- Pharm (registered with SAPC as a pharmacist)
Previous experience as a Responsible Pharmacist (preferable) with oversight of warehousing and distribution activities
- Demonstrated leadership/influencing skills in a GxP environment; preferably within a quality role
- Ability to both lead and support and a track record of business partnering with internal stakeholders
- Experienced in leading regulatory inspection audits and management of health authority responses
- Experience managing near term priorities and strategic aspirations
Should you not be contacted within 7 days, please consider your application as unsuccessful.