Job Ref #: AI-370
Industry: Pharmaceutical And Medical/Healthcare
Job Type: Permanent
Positions Available: 1

Job Description

Adcock Ingram Holdings Limited and its Subsidiaries (“we”, “us”) is committed to protecting and respecting your privacy. Our Privacy Notice sets out the basis on which personal information collected inter alia from you, social media, recruitment agencies and our website, will be processed by us. The Privacy notice is available on our website www.adcock.co.za.

 One of the conditions under the Protection of Personal Information Act 4 of 2013 (POPIA) provides that candidates have the right to be informed about the collection and use of their personal information,

 In the course of your application: we may

• collect personal information that may be used to identify potential professional opportunities other than the job you have applied for but of which we think might be of interest to you.
• use your Personal Information to confirm references or background checks you have provided us.
• request your consent to participate in aptitude tests or recruitment assessments.

 We also use your personal information to respond to your inquiries, to verify your information and to share information with you.

 Your personal information will be securely stored by the Human Capital Department and it will be retained for a period of up to 12 months as of the closure of the application procedure if your application is unsuccessful, and in case of a successful application and you are hired, your data will be transferred to your personal employee file.

 By applying for this position, you consent to us processing your personal information.

 We reserve the right to make an appointment. If you have not heard from us within 30 (thirty) days of the closing date, please accept that your application was unsuccessful. Correspondence will be entered into only with shortlisted candidates.

Please note that this appointment will be made in line with company’s employment equity policy and divisional employment equity targets

Job Purpose:

• Provide support to the QA Compliance Manager ensuring CAPA effectiveness monitoring is performed for all Corrective actions implemented at site, in relation to internal and external audits.
• Perform Personnel change room locker inspection.
• Perform daily GMP walkabouts in the factory and warehouse.

Inform management of all non-compliance detected, follow-up on the corrective actions.

Key Outputs:

• Ensure strict adherence to gowning and de-gowning procedures in the facility.
• Ensure prohibited items are not always found in the personnel lockers and manufacturing facility.
• Ensure premises and equipment of all classified areas, including the laboratories, are well maintained and compliant.
• Review Pest control report monthly and quarterly.
• Review room cleanliness and cleaning logs. Ensure that there are no fading / peeling labels or demarcation tape.
• Perform line opening activities with the production team.
• Ensures that cleaning and routine flushing activities are executed as per departmental standard operating procedure, and documented correctly
• Check the compounding area and water plant for leaks and report to the relevant department.
• Check the sterilisation trucks for deterioration.
• Ensuring that truck loading patterns are strictly adhered to in the prevention of extreme overlapping and compromising the sterilization process of the product
• Check the calibration status and tags of online meters and gauges.
• Check the differential pressure readings that they are within limits at the start of the shift and report any out of limits.
• Perform in-process production inspections.
• Check the validity of departmental SOP’s and report any superceded SOP found.
• Packing area: ensure that all visual inspection booths and conveyor belts are clean, smooth and not damaged.  Lux verification is performed with a calibrated instrument.
• Compile a monthly report for all non- compliance and follow up on the corrective actions provided.
• CAPA effectiveness.

Special Knowledge, Skills and Duties:

GMP and Quality Systems

• Deep knowledge of GMP regulations, quality management systems, and pharmaceutical manufacturing standards.
• Proficient in auditing techniques and compliance assessments.
• Familiarity with local regulatory requirements related to pharmaceutical manufacturing and packaging.

 

Problem Solving and Corrective Actions

• Strong skills in identifying root causes of GMP deviations and implementing effective corrective actions.
• Proficient in the development and implementation of CAPAs.

 

Documentation and Reporting

• Expertise in maintaining accurate documentation and GMP records for regulatory audits.
• Ability to prepare clear and concise compliance reports for both internal and external stakeholders.

 

Training and Development

• Ability to develop and deliver effective training programs on GMP compliance and quality assurance.
• Capacity to assess the effectiveness of training and identify knowledge gaps within the team.

 

Pharmacovigilance Principles:

• Understanding of pharmacovigilance practices for monitoring and reporting adverse events.
• Commitment to contributing to pharmacovigilance efforts.

 

ISO 13485 Standards:

• Basic awareness of ISO 13485 standards for quality management systems.
• Recognition of the importance of quality management systems in ensuring product safety and compliance.

 

Interpersonal Skills:

•   GMP and quality-focused mindset with a strong commitment to compliance and regulatory standards.

•   Meticulous and detail-oriented approach to inspections, documentation, and reporting.

•   Ability to work effectively under pressure while maintaining accuracy and quality standards.

•   Strong teamwork skills with the ability to collaborate across departments and functions.

•   Ability to work independently with minimal supervision and demonstrate initiative.

•   Good verbal and written communication skills for effective stakeholder engagement and reporting.

•   Strong observation, analytical, and problem-solving skills.

•   Ability to identify non-compliance issues and follow through on corrective actions.

•   Excellent organizational and time management skills.

•   Professional, responsible, and accountable work ethic.

•   Ability to maintain confidentiality and exercise sound judgment.

•   Adaptability and flexibility in a dynamic manufacturing environment.

Job Requirements

Other

• In-depth understanding of PIC/s, GMP, GLP, and relevant local regulations
• Ability to create, implement, and maintain Standard Operating Procedures (SOPs) related to GMP
• Strong understanding of quality assurance processes, quality risk management, and corrective/preventive action (CAPA)
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and GMP compliance software

·        Experience in training staff on GMP compliance and regulatory standards Qualifications

• Bachelor’s degree in biotechnology, Microbiology, Chemistry, Total Quality Management or related field
• Registered with the South African Pharmacy Council (SAPC) (if applicable)
• Postgraduate qualifications in Quality Assurance or a related field would be advantageous

Experience ·        1 – 2 years’ experience in the pharmaceutical industry.

• Sound knowledge of SAHPRA and PIC/s cGMP Guidelines
• Proven experience in auditing, quality control, and regulatory compliance
• Familiarity with the Medicines and Related Substances Act and relevant South African regulatory requirements
• Experience in monitoring and ensuring adherence to GMP standards in all phases of pharmaceutical production

·        Hands-on experience with GMP audits and the preparation of compliance reports