Job Description

KEY RESPONSIBILITIES

Product release

• Assist with any/all documentation relating to product release and the accurate capturing of records and data.
• Assist with the control and storage of release samples.
• Perform Lot release checks according to prescribed procedures to ensure GMP compliance.
• Assist with Data Logger handling and temperature monitoring activities.

Operational activities:

• Assist with delivery of day-to day Quality Assurance activities, ensuring adherence to plans and schedules.
• Assist with the accurate completion of all database entries, registers and forms.
• Assist with the compilations and/or reviews of departmental SOPxe2x80x99s.
• Assist with recording of CAPAxe2x80x99s, deviations and any other reports.
• Assist with quality related investigations.
• Assist with recording and arranging destructions as and when required.
• Liaise with suppliers as and when required.
• To carry out any other administrative duty as and when required
• Assist with annual reviews per product including but not limited to report preparation, sample inspections and supplier requests.
• Assist with tracking, communication, and support of annual QA plan activities.
• Assist with review of laboratory and/or stability results.

Good Manufacturing practice (GMP)

• Maintain all GMP principles in line with departmental Quality System and SAHPRA requirements.

Training

• Attend and/or present training sessions as and when required.

PRE-REQUISITES

Post Basic Pharmacist Assistant or Bachelor of Science

COMPETENCIES

Adaptability and Flexibility _ Level 1 _ Operational

• Maintains an effective work style when experiencing changes in work tasks, processes or environment
• Remains focused on task despite changes
• Keeps own emotions from interfering with work
• Recognises and adopts positive aspects of change
• Responds to change with appropriate sense of commitment

• Actively engages in change to better understand the effects on own role

Building interpersonal Relationships _ Level 1 _ Operational

• Establishes a rapport with others
• Works well with people from diverse backgrounds
• Recognises the need for additional buy-in or support from decision makers to achieve objectives
• Works to be accepted by peers and co-workers
• Balances personal needs and those of onexe2x80x99s team with the needs of the broader company

Client Services and Support _ Level 1 xe2x80x93 Operational

• Asks questions to identify needs and expectations
• Responds with the appropriate level of urgency
• Takes into account the impact on the client when carrying out onexe2x80x99s own job tasks
• Takes personal ownership in ensuring that expectations are met
• Asks questions about the satisfaction with the service provided

Work Management_ Level 1 _ Operational

• Sets priorities with an appropriate sense of what is most important
• Manages time effectively to accomplish what needs to get done
• Knows the status of own work at all times

• Participates in planning sessions that affect own team

Quality Commitment and Work Standards _ Level 1_ Operational

• Pays attention to the quality of onexe2x80x99s own work, checking for the accuracy of work produced
• Provides information on a timely basis and in a usable form to others who need to act on it
• Completes all work according to defined procedures and standards

• Looks for potential improvements in own area of responsibility

Resilience and Tenacity _ Level 1 _ Operational

• Pursues objectives with energy and persistence
• Sets high personal standards for performance
• Adapts working methods in order to achieve objectives
• Accepts ownership of and responsibility for own work

• Does not give up at the first obstacle

Results Focus and Accountability _ Level 1 _ Operational

• Clarifies results/expectations for all work he/she is taking on; goes back to manager if there is any lack of clarity about results/ expectations
• Stays focused on task despite distractions, demonstrating commitment to the successful achievement of challenging goals
• Clearly defines the expected output and results of all assignments and projects

Teamwork and Collaboration _ Level 1 _ Operational

• Contributes willingly towards the accomplishment of own and team goals, doing his or her share of the work
• Demonstrates respect for the opinions and ideas of others
• Does not remain silent or withhold differing opinions in team settings
• Is willing to accept compromises to progress toward the achievement of group goals
• Follows through on commitments made to other team members

• Keeps people informed and up to date

Pharma Dynamics