Leading Pharmaceutical Company has a vacancy for a Compliance Coordinator to be based in Cape Town

Purpose of position:
To support, administer and maintain systems that ensure regulatory compliance and the quality control of all products. To mentor junior staff

KEY RESPONSIBILITIES:
Maintain the contractor master documentation repository and ensuring that the company is in regulatory compliance with its current MCC licensing conditions for manufacture, packing and testing
Create, review and update Lot Release Forms per product, Product Trend Chars per product, Sop’s, Printed Packaging Material inspection reports, Bulk inspection reports and any other related QA forms, templates and registers
Coordinates the timeous sampling of incoming goods at the contract distributor and/or packer
Coordinated the timeous testing for post importation requirements and documentation thereof with contract laboratories
Compile and maintain the samples register and liaise with contractors
Coordinates, compiles and reviews all batch documentation relating to the lot release of all products - manufacturing, packaging and analytical records - in compliance with registered dossiers
Performs Bulk material inspections before packaging and liaise with contractors, maintain registers
Performs final packed product inspection, maintains the product trend charts and updates the lot release summary for all products on an ongoing basis
Coordinates the timeous final product release to market of all products by the Finished Product Release Pharmacist
Ensuring starting materials and bulk products are promptly released at contract packers
Create, review and maintain Printed Packaging Material Reference Masters
Proofreads artwork of products for compliance to quality requirements as part of the packaging approvals
Co-ordinates mass changes to packaging artwork as required by internal management decision, local regulations and/or the countries of export
Fields on-line issues and deviations at contractors to avoid an impact to quality and regulatory compliance of company products
Coordinates the importation testing program at the various contract laboratories
Coordinates the analytical reference standards at the various contract laboratories Field Product Reworks (Redress) with contractors to ensure compliance to quality and regulatory requirements of the company and as dictated by the dossier.
Coordinates and maintains the stability program and compiles, review and maintain the related register, logs and reports – covering the program on Bulk material as well as Finished Packed Product
Captures all stability study data generated and compiles stability summary reports
Assists with maintenance of Standard Operating Procedures (SOP’s).
Handles and logs quality complaints from the trade and the sales force
Handles and logs quality related credit returns
Coordinates Destructions; liaise with contractors and compile and maintain records.
Preparation, compiling and maintenance of new business development projects (New products)
Preparation, compiling and maintenance of all quality related issues for the Export markets
Coordinates and maintains the Product Quality Review (PQR) and compiles, review and maintain the related register, logs and reports – Conduct the review
Assist with training and maintenance of training material and records
Ensures all quality records and compliance documentation are filed appropriately
Update the Companies electronic Document Management System with all relevant information

PRE-REQUISITES
A science based degree in Chemistry or similar.
Minimum of 3 years work experience in a quality control position

TECHNICAL COMPETENCIES REQUIRED
Primarily a detailed knowledge relating to all aspects of quality control
Sound knowledge of the most recent analytical laboratory techniques, packaging analysis, in- process requirements and production controls
Knowledge of pharmaceutical, generics or consumer healthcare industries
Knowledge of production and packaging technology
High computer literacy and able to effectively use Excel
Up to date knowledge of validation, GMP and GLP would be valued

BEHAVIOURAL COMPETENCIES REQUIRED
Highly accurate and has good attention to detail
Highly organized and good planning skills
Analytical and evaluative ability
Effective written and verbal communication skills
Ability to work in flexible and dynamic environment
Pro-activity and task oriented
Organized and thorough
Alertness
Work well as part of a larger team
Able to work independently

Should you receive no response within 7days, please consider your application unsuccessful