Job Purpose
Working with cross-functional teams, you will have to be an excellent communicator and will be responsible for ensuring that all projects have the appropriate local quality, safety and regulatory input and guidance.
Ensuring compliance with the legislative requirements as set out in the Medicines and Related Substances Act 101 of 1965 and Pharmacy Act 53 of 1974, as well as all applicable legislative requirements for the companys product portfolio.
You will have a solid knowledge GMP/GDP/GWP, Supply Chain, Compliance and Pharmacovigilance systems and have previously worked within the Pharmaceutical industry.
Principal responsibilities of the role
Legal
Act as Deputy Responsible Pharmacist and ensure compliance with the legislative requirements as set out in the Medicines and Related Substances Act 101 of 1965 and Pharmacy Act 53 of 1974, as well as all applicable legislative requirements for the companys product portfolio.
Responsible for RP responsibilities as delegated during RPs absence
Ensure compliance with statutory and regulatory requirements of SAHPRA, DoH, SA Pharmacy Council and related authorities in South Africa and other African countries where Guerbet products are sold.
Support activities to ensure compliance with the SA Marketing Code and comply with Global marketing policies.
To approve and sign off advertising material and to ensure that the material is legal.
Support activities to ensure implementation of ISO 13485:2016 requirements for a quality management system where the organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
Understand and apply Medical Device guidelines in the local subsidiary.
General
Ensure good relations and communications with all members of the team and responding respectfully and in a timely fashion to internal and external customers.
Interact influentially with all members of staff to maintain and develop a positive progressive Quality culture throughout the facility.
Support with submission of SEP (Single Exit Price) increases in a timely manner
Customer Account validation
Support with execution of projects as required
Quality Assurance
Ensure that the business complies with cGMP and ISO 13485 standards and requirements.
Support during regulatory body inspections (SAHPRA and SAPC).
QA batch release of fully finished imported pharmaceutical product by reviewing batch manufacturing-, packing- and analytical records prior to batch release.
Reviewing PQRs and engaging with relevant departments to address recommendations and outstanding information.
Oversee the Customer Complaints system and facilitate investigations to establish root cause and effective CAPAs.
Administration and support of the QMS, including quality management meetings, change controls, GMP deviations, quality risk assessments, customer complaints, periodic reviews, self-inspection and external audit reports, and SOPs.
Initiate and review quality documentation, change controls, CAPA and Good Manufacturing Practice (GMP) deviations if necessary.
Update and review Standard Operating Procedures (SOPs) and ensure compliance with Global SOPs.
Assist with internal self-inspection audits and response report.
Support with executing the internal training schedule, provide GMP training, GWP and applicable SOP training to staff.
Ensure that most current and correct FP specification of registered products are provided to the PIT laboratories.
Support supply chain activities pertaining to Guerbet products and medical devices performed by the subcontractor. Ensure that these activities are performed in compliance with the local legislation and regulations, and GDP/GWP/GMP.
Management of Returned goods.
Support Supply Chain team with Inventory management.
Pharmacovigilance/Materiovigilance
Act as Deputy Local Responsible Person for Pharmacovigilance/Materiovigilance
Maintain the local PV policy according to the Group PV policy, strategy and objectives as defined by the Corporate PV department.
Apply measures intended to minimize these risks, to promote the best usage of the products and to guarantee the patients safety in her/his country.
Use all necessary tools to evaluate the quality of the global PV processes and activities.
Support with conducting PV training in subsidiary where applicable.
Report ADR(s) to the Pharmacovigilance department in France.
Support routine or triggered internal and external Pharmacovigilance Quality Assurance audits.
Support execution of CAPAs for Pharmacovigilance related audit and inspection findings
Support with authoring and review of Pharmacovigilance SOPs and guidance documents.
Relationship with others
Internal: Pharmacovigilance, Regulatory Affairs, Quality, Commercial and sales teams, Customer Services.
External: Regulatory Authorities and Industry Associations.
Profile description:
Requirements / Expectations
Education:
University degree as a Pharmacist
Expert knowledge in GDP/GWP and GMP
Adequate knowledge of current GVP requirements
Knowledge in the field of Supply Chain.
Experience:
Minimum 2 years QA experience or relevant experience in pharmaceutical/medical device industry
Sound experience in quality assurance
Excellent knowledge of the legislative requirements
Demonstrable knowledge of Pharmacovigilance processes, across multiple Pharmacovigilance disciplines
Knowledge of document management/quality systems
Preferred Skills/Qualifications:
Fluency in written and spoken English
Strong and effective communication and interpersonal skills
Excellent analytical, problem solving and decision-making skills
Able to work independently, well organized, correct and timely
Ability to adapt to changing direction and needs of the business and directly apply this knowledge to daily tasks and assignments
Attention to detail, initiative, confidentiality, customer focused, logical thinking, information seeking and sense of urgency
Excellent computer skills
We offer:
When you join Guerbet Group, you
- Are choosing the worlds leader in the technological sector of diagnostic and interventional imaging,
- Are joining our 2600 collaborators who are committed every day to offering innovative solutions to improve quality of patients life in more than 80 countries all over the world,
- Are joining a company where we value our diverse team coming from various horizons.
To learn more and to apply, feel free to visit our website: www.guerbet.com
