Quality Assurance Controller - Somerset West Verfied Gold Badge

R 45k - 50k per month Somerset West, Western Cape Somerset West, Western Cape more than 14 days ago 04-10-2018 2:19:18 PM
01-11-2018 2:19:18 PM
International Pharmaceutical Company based on the East Rand has a vacancy open for a Quality Assurance Controller (2IC to the current Quality Assurance Manager).
We are looking for a dynamic individual with a Relevant Scientific Degree/Diploma who is familiar with GMP and ISO 22000 FSSC. The right applicant for this position will have 5 years’ experience in pharmaceutical/ chemical or nutritional supplements sector;

What will I be responsible for in this position?

• Ensure documentation and procedures are continuously reviewed and updated as per management directive, local standards, and regulations
for Forward Solutions.
• Assist other departments with identifying and creating new procedures.
• Manage control of all forms, reports, records, and new documents created, control their issue and the archived documentation.
• Manage Forward Solution test specifications by;
o Reviewing and creating worksheets on SAP.
o Developing Test criteria.
o Managing external testing where required
o Maintaining master file of all worksheets

• Review all batch records, capture results and release product for sale.
• Investigate and manage all deviations related to Forward Solutions
• Participate in MOC investigations
• Manage all Forward Solution Toller quality
• Coordinate and performs Toller audits
• Manage the Validation activities of the site.
• Perform line opening, closing and in process checks for all Forward Solution packing on site.
• Deputize for the QA Manager in his absence taking on the responsibility of material release.
• Projects/Special Assignments

• Premix and Forward Solutions Stability program;
o Compile stability protocols and test criteria based on relevant
o reference material and regulatory requirements
o Manage outsourced storage
o Control time interval sample extraction and submission for analysis
o Review results
o Trending of results
o Compilation of stability reports
o Manage stability program by identifying new trials and termination of obsolete trials

What experience and qualification do I need to apply?
• Relevant Scientific degree/diploma
• Familiar with GMP and ISO 22000 FSSC
• Knowledge and 5 year experience in pharmaceutical /chemical or nutritional supplement sector
• Must have experience in initiating and maintaining a stability program.
• Must have experience in compiling and interpreting stability data
• Supplier auditing
• Accuracy and attention to detail
• Understanding and adherence to SOP’s
• Ability to work to a demanding work schedule
• Analytical thinking
• Ability to plan and organize an effective work flow
• Conscientious and responsible
• Ability to work under pressure

Recruiter: ITS Personnel