Lot Release Pharmacist at Johnson & Johnson

The main duties and responsibilities of the position are:

The Individual will be responsible for the following.

• Ensuring products are released in accordance to the manufacturing, packaging procedures, regulatory requirements and product specifications.
• Lead the collation, storage, retrieval and destruction of batch and related quality documentation and samples, ensuring retention stores remain in a state of GMP Compliance
• Handle Customer Complaints and ensure that complaints are investigated in accordance with company policy and procedures and regulatory requirements when required.
• Review of Quality related documentation e.g. Investigations, CAPA's, Change Controls, Master Documents and Product Quality Reviews.
• Oversee the Sampling and management of scheduled substances.
• Compilation of Quality related Documentation e.g. CoA, CoC’s, First Article inspections.

The individual will have the opportunity to perform internal Quality audits and Gemba walks as the need arises to ensure the plant meets compliance requirements. This will allow the individual to build their QMS knowledge and participate in Problem-Solving and Quality Improvement initiatives.

Qualifications

We’d love to hear from YOU, if you have:

Education

• Grade 12
• Tertiary qualification (Professional/Technical/ Academic) B. Pharm Degree/ Diploma in pharmacy- Registered with the South African Pharmacy Council

Experience

• Experience in Pharmaceutical Manufacturing Industry
• Experience in a Quality Related role in pharmaceutical Manufacturing
• Experience in Batch record review and Lot Release will be advantageous
• Knowledge of Quality Management Systems with a general understanding and application of cGMP Principles (Act 101 1965)

Skills

• High attention to detail including a logical approach to problem solving and troubleshooting.
• Strong analytical skills, and a meticulous method of working are essential.
• Demonstrates an ability to work in a fast-paced diverse team environment while taking personal responsibility for decisions and driving results.
• Communicate effectively with co-workers and management on results and status of release or projects. Ability to give and receive constructive and candid feedback. Ability to manage assigned work independently is required.