Pharmacist Intern at GlaxoSmithKline (GSK)

Job description

Basic qualifications:

• Minimum of B Pharm or BSc Pharm
• Registered as a Pharmacist Intern with the South African Pharmacy Council

Experience

• No experience required
• Training
• In-house induction
• Relevant GSK policies procedures, processes and systems.
• GMP, QMS, EHS and GPS requirements.
• Continuing education with focus on current Act 101/1965 and Act53/1974
• Job specific Intern Training Curriculum (in-house) including -
• Core SOPs
• On-The-Job Training

Preferred qualifications:

Job Purpose

• To enable the Pharmacist Intern to apply in practice his / her theoretical knowledge and also to gain practical experience within a pharmaceutical manufacturing environment under the supervision of a registered pharmacist.
• Scope
• Practical application of legal and ethical aspects of professional practice
• Broad understanding of all activities within a pharmaceutical manufacturing facilities required to produce pharmaceuticals
• No direct reports.

Essential Job Responsibilities

Works under the professional supervision of a registered pharmacist whilst rotating through various departments and value streams across the Site.

Key Performance Area

GMP & Compliances

Works in manner that ensures products are manufactured to the required quality and compliance standards.

• Performs operational activities across Site following training, in compliance with applicable Pharmacy Act and Medicines Act requirements.
• Complies with applicable cGMP requirements.
• Assists in assuring the "In Place" and "In Use" status of GMP systems and procedures relating to the prevention of contamination, cross-contamination, mix-ups and maintenance of good documentation practices.
• Assists in ensuring compliance to relevant GSK policy and SOP’s.
• Liaises with the Production Pharmacist, Quality Assurance Manager and/or the Responsible Pharmacist regarding all product quality-related issues.
• Supports continuous quality improvement by participating in Quality-related trouble-shooting, problem solving and root cause investigations.
• Participates or completes additional activities including L1 Self Inspections, CAPA implementation, Change Control activities, etc as required.
• Assist with inventory management and stock control of scheduled and unscheduled pharmaceuticals
• Assist with the training and mentoring of production personnel.
• Participates in ZDP (Zero Defect Promotion) Program
• Environmental Health and Safety (EHS)
• Works in a safe manner & promotes safety on Site.
• Required to take reasonable care for their own health and safety.
• Carries out work in accordance with prescribed practices and procedures and in a manner that will not create health and safety hazards for either the employee or others in the workplace.
• Complies with and enforces use of EHS SOPs at operational level
• Complies with and enforces regulations pertaining to dress code and safety equipment at operational level.
• Participates in ZAP (Zero Accident Promotion) Program
• Operations
• Assists in executing Operational activities in accordance with agreed supply plan.
• Assists with compliance related activities in order to deliver the production schedule.
• Assists in supervising various stages of production
• Assists in completing batch documentation.
• Assists in Line Clearance checks, Line Opening checks, etc.
• Participates and may initiate trouble-shooting, problem solving and resolution of any obstacles in achieving agreed supply plan.
• Assists in investigating reconciliation discrepancies or other quality problems.
• General
• Perform all tasks and duties within the GPS framework
• Carries out relevant non-specific duties across the Site as requested
• Performs Administrative Activities e.g. day-to-day administrative tasks such as maintaining information files and processing paperwork.
• Assist with collection, collation and maintenance of information and data.
• Is an active team member by working cooperatively and effectively within the team
• Uses various computer systems in the execution of duties e.g. BPCS, email, Track Wise, etc
• Communicates well with Supervisors, Peers, or Subordinates - Providing information to supervisors, co-workers, and subordinates by telephone, in written form, e-mail, or in person

Person Specification

• Good Interpersonal Skills
• Good Organizational Skills
• Good Communication Skills
• Uses Initiative and is self motivated.
• Excellent Numeracy and Accuracy Skills
• Excellent attention to detail
• Ability to trouble shoot and solve problems
• Ability to work under pressure to deadline.
• Ability to work overtime and shift work if required

Knowledge

The job holder must have

• An understanding and knowledge of Good Manufacturing Principles.
• An understanding, knowledge and applicability of the Regulatory (MCC) requirements within a manufacturing environment.
• An understanding and knowledge of the Site and Value Stream's EHS and QMS requirements.
• A detailed knowledge and understanding of various compliance procedures e.g. Line Clearance, Line Opening, etc.
• A good understanding of the GlaxoSmithKline Production System, the GPS standards and its integrated approach
• Working knowledge of Microsoft packages – Excel, PowerPoint and Word

Complexity

The job holder must

Balance the demands for supply with that of Regulatory, Quality & Safety requirements - see GSK Judgment Ladder.
Performs a variety of tactical routines, some of which are diverse, e.g. Line Clearance, Line Opening, etc under the direct supervision of a registered pharmacist.

Independent Thinking

This position is highly governed by policy and procedures; however opportunity exists for independent thinking relating to improvement of processes and systems.

The job holder must be capable of using his own initiative, be progressive in approach and understand his/her limitations in terms of the Regulatory / QMS /EHS requirements.
Examples including improving existing processes, etc

Responsibility

• Compliance with Pharmacy Act 53 of 1974 and Medicines & Related Substances Act 101 of 1965 requirements
• Comply to GMP, safety (product and personal) and relevant regulatory authorities
• Escalates problems due to poor performance on specific lines.