Purpose:

A pharmaceutical company is looking for a Responsible Pharmacist & Head of Quality who is responsible to develop, maintain and continuously improve the Quality System to ensure that all products manufactured, analysed and distributed on behalf of the company meet the desired specifications. Be part of a critical part of the local Quality Assurance team in order to improve Quality Culture, focus on compliance, build program (with the assistance of GOA) to support key programs such as data integrity, investigations, manufacturing controls including PPQ, product health, Cleaning, Laboratory, Cross-training and GOA audits

Ensure that the Company meets its statutory requirements in terms of the Medicines & Related Substances Act 101 of 1965, Pharmacy Act 53 of 1974, and the relevant Regulations and guidelines, as amended from time to time. Lead, train and mentor a team of Quality personnel comprising of Pharmacists and QA Officers, ensure that Final Product Release Responsibility Criteria are met for all the company products and the release thereof for sale on the South African market. Establish and ensure that Regulatory Affairs processes and Quality Systems are in place to ensure Regulatory compliance in the event of Regulatory Body inspections, discharge all duties as required of a Responsible Pharmacist for the company (Applicant) as per current legislation. Review, build strong relationships with Contract Sites and manage all processes and procedures to ensure an efficient, compliant Quality Operations System

Key Job Outputs:

• Manage and be accountable for the release of batches
• Responsible for Quality Complaints Investigations
• Ensure that all quality and legal files are current and in place, vis. Applicant Site Master File, Inspection File, Quality Manual, APQR, Technical Agreements
• Ensure adherence to MCC, SAPC GMP and GDP guidelines by all relevant personnel
• Ensure that all APQR's generated by the manufacturer for each product have been received, reviewed, summarised and signed off
• Ensure the implementation of transport validation for all products which are imported
• Ensure that all third-party contractors / vendors are audited timeously and that audit reports including responses are available on file
• Assist with Regulatory Authorities’ inspections and readiness
• Ensure responses to all inspection reports received from Regulatory Authorities are compiled and submitted within timelines
• Keep company documents updated with Regulatory Authorities
• Investigate and compile reports on any OOT, OOS results and deviations
• Ensure that the stability data for each product is up to date
• Ensure that the validation reports for each product are received timeously from manufacturers
• Manage products which are returned from the market
• Ensure that all systems are in place to ensure products are traceable at any given time in case of a recall
• Provide support for any Pharmacovigilance queries for the Applicant's products when required
• Review, approve and file all technical documents (subsequent versions of batch manufacturing documents, change controls, non-conformities etc.) to ensure product regulatory compliance
• Develop and maintain SOPs in line with the latest GMP/GDP and the company Policies requirements
• Lead, train, provide advice, guide and mentor the Quality Assurance personnel to develop their skills and abilities
• Provide technical support to commercial partners for manufacturing and distribution activities
• Review and approve Product Master Documents
• Implement, manage and monitor the KPA's of direct report
• Ensure timeous quality activities related to the release of products for sale in order to meet commercial objectives
• Ensure adverse events are handled and reported timeously as per regulatory requirements
• Ensure compliance of all marketed & promotional materials in line with legal requirements
• Manage and compile local and Global Monthly metrics reports
• Be responsible and accountable for the review and approval of all contract site’s change controls and deviations, including the Regulatory impact assessment and the follow-up on ensuring the obtaining of the relevant documentation resulting thereof

Core Competencies:

• Extensive Quality Assurance experience in the Pharmaceutical Manufacturing and Distribution environment
• All relevant Acts, legislation, regulations, and guidelines that govern the Pharmaceutical Industry
• Leadership abilities – train and develop teams
• Planning and Logical thinking ability
• Proactive solution orientated
• Relationship building ability
• High level of assertiveness, self-confidence, honesty, and reliability
• Ability to analyse problems, identify alternative solutions, project consequences of proposed actions, and implement recommendations in support of goals
• Good professional written and verbal communication and interpersonal skills
• Ability to motivate teams to produce quality materials within tight timeframes, simultaneously manage several projects, and participate in and facilitate group meetings
• Excellent inter-personal skills to liaise with other departments, customers, Third Party contractors and Global teams

Qualifications:

• B. Pharm Degree
• Registration with the South African Pharmacy Council as a Pharmacist

Experience:

• Minimum 5 years of experience in pharmaceutical Quality teams
• Knowledge of pharmaceutical manufacturing processes
• Management and technical experience in Regulatory Affairs
• Experience in dealing with Regulatory Authorities
• Experience in other technical departments (QA, QC, Production)

Salary: Market related

Should you not hear from us within 2 weeks, kindly consider your application as unsuccessful.

All personal information received will be processed in accordance with The Protection of Personal Information Act No. 4 OF 2013