Website Adcock Ingram
Adcock Ingram is a leading South African pharmaceutical company with a proud 130 year heritage. It has a portfolio of trusted, quality brands and generics and an entrenched value system that assures integrity. Growing from humble beginnings as a small Krugersdorp pharmacy in 1890, Adcock’s portfo… read morelio includes an extensive range of Prescription, Over-the-counter (OTC), Consumer and Hospital products and life saving hospital products.
Key Job Output
Legal compliance to SAHPRA/PICs, cGMP requirements and Pharmacy Council requirements.
To ensure that all validation related audit points identified during internal and external audits are closed timeously.
To ensure that new and updated Guidelines and Policies from SAHPRA and other Regulatory bodies related to pharmaceutical industry are used at all times when developing internal documentation.
Qualifications and Validations
Compiling and updating a Validation Master Plan (VMP) and relevant Validation Plans (VPs).
Ensuring the qualification of all facilities and utilities areas as per Validation Schedule.
Standardising validation approach ensuring consistency of application in accordance with agreed timelines and schedules.
Ensure qualification of all equipment and validation of processes as per the equipment train and product portfolio.
Ensuring the requalification and/or periodic reviews of all qualified equipment and utilities as per Validation Schedule.
Comprehension of sterile manufacturing concept and associated processes such as the media fill, media hold, dirty and clean hold time studies.
Determining test requirements and detection limits for validation samples to the Laboratory.
Coordinating site calibration activities for all critical instruments and equipment.
Samples Analyzed and report all non-conformances and failures.
Providing recommendations and guidance on changes related to manufacturing process, equipment and procedures.
Performing cleaning validations and ensure that the cleaning validation matrix for all departments is maintained, protocols and reports are prepared in time.
Proficiency in computerised system validation and application of relevant guidelines such as 21 CFR 11 Part 11, PIC/S Annex 11, GAMP 4, GAMP 5 etc.
Compiling and updating departmental SOPs, protocols and reports.
Proficient in the use of structured problem-solving tools and Quality Management System such as RCA (Root Cause Analysis), FMEA’s (Failure Mode effects analysis), Change Control, Deviation, Corrective and Preventative Actions etc.
Proficiency in project management and use of relevant tracking tools.
Managing budget, operating and capital expenses.
Self-development
Study new guidelines and policies from SAHPRA/PICS to keep abreast with developments and changes with regards to legal aspects and regulatory requirement pertaining to pharmaceutical, product manufacturing.
Identify and communicate any skills/training requirements to help execute tasks efficiently.
Time Management and Self Discipline
To ensure time keeping at all times
To ensure that tasks allocated to individuals are performed and presented in time as scheduled
Requirements
Degree within Natural Sciences or Engineering
Minimum of 5 years in pharmaceutical validation experience of which 2 years must be as a Validation Manager.
Apply via company website ( N / A ) or
adcock.mcidirecthire.com