Fresh Opportunities at Pharma Dynamics (Pty) Ltd

Description

KEY RESPONSIBILITIES

Operational efficiency

• Contribute to the creation and implementation of best practice processes and procedures to aid and improve operational performance and timeous release of product to market.
• Contribute to timeous implementation of QA projects.

Operational activities:

• Conduct, manage and coordinate batch release reviews and approve final product release to the market as per the legal requirements and guidelines set by SAHPRA and the Department of Health, and in line with the registered dossier.
• Always maintain and coordinate all the GMP principles as required by the SAHPRA as stipulated in the latest version of the SAHPRA / PIC/S (Pharmaceutical Inspection Co-operation Scheme) guidelines for cGMP and related systems and procedures to ensure compliance.
• Liaise and coordinate with relevant 3rd parties to ensure all pre-requisites are available to action a product release.
• SAP releasing and processing, including but not limited to batch creation and amendments.
• Ensure direct communication and continuous pursual of achieving annual plans and schedules (including but not limited to annual stability plan, annual product quality review schedule, Quality Agreement renewals, annual audit plan, departmental training plans).
• Liaise and communicate any anomalies, non – compliances and discrepancies to the rest of the team and assist with deviations and investigations.
• Ensure accurate capture of data across all electronic platforms.
• Assist with any product related GMP activities, including but not limited to stability, annual product quality reviews, quality agreements, audits and risk assessments.
• Review of executed Batch Manufacturing documents received from 3rd parties.
• Assist in product recalls/mock recalls.
• Ensure Head office sample storage is accurately controlled and ensure S6 and SS5 registers remain balanced at all times.
• Maintain in-house documentation relating to QA processes, ensuring compliance with current SAHPRA licensing conditions for import and export functions (procedures, forms, registers, records and reports).

Review and monitor the below but not limited to:

•  Product change control process
•  Issue log (Including deviations, CAPAs, change control process, Investigations)
•  Destructions
•  Risk Assessments
•  Internal QMS documents: SOPs, forms, registers and records
• Temperature monitoring during transportation.

General

• Perform any other duties as per changes in operational requirements of the department.
• Perform any other duties as required.

Requirements

 PRE-REQUISITES

• B. Pharm registered with the SA Pharmacy Council.
• Minimum of 2 years Quality Control or Quality Assurance hands-on experience within the pharmaceutical industry.
• Knowledge of the quality environment within the pharmaceutical industry.
• Working knowledge of cGMP and the maintenance of Quality Management Systems.
• Working knowledge of the requirements and process of batch release to the market.

COMPETENCIES

Adaptability/Flexibility: (Level 2_ Tactical Lower)

• Adjusts to work effectively within new work structures, processes, requirements, or cultures
• Views change as opportunity to improve
• Willing and eager to change
• Actively seeks out positive spin-offs of change and investigates ways in which change can be used
• Anticipates change and continuously remains prepared for change
• Demonstrates resourcefulness in acquiring necessary knowledge, skills and competencies to adapt to change

Professional Knowledge and Skills (Level 3 _ Tactical Higher)

• Thorough understanding of the knowledge / skill area
• Effectively applies a broad range of principles, practices and procedures in the knowledge / skill area
• Is sought out by others for advice for the resolution of difficult problems
• Can work independently
• Keeps up with current developments in area of expertise

Analytical Thinking/Problem Solving (Level 2 _Tactical Lower)

• Appropriately derives and organises the essence of information to draw solid conclusions
• Effectively resolves problems of a moderately complex nature
• Synthesises data from different sources to identify trends
• Looks beyond symptoms to uncover root causes of problems to be solved
• Presents problem analysis and a recommended solution rather than just identifying and describing the problem itself
• Proactively approaches others to obtain missing information
• Takes action to reconcile discrepancies

Resilience and Tenacity: (Level 3 _Tactical Higher)

• Tackles difficult and complex problems and takes personal responsibility and accountability for reaching solutions
• Remains determined despite frequent obstacles
• Maintains enthusiasm of others after disappointment or rejection
• Bounces back very quickly
• Leads others through dealing with disappointment/rejection
• Re-engineers or creates new processes and systems to get around obstacles
• Anticipates problems and proactively designs contingency plans

Quality Commitment and Work Standards: (Level 2 – Tactical Lower)

• Pays attention to the processes or elements leading to the accomplishment of results within own team or department, looking for ways to improve quality and efficiency
• Examines output of own department, looking for potential improvements
• Establishes measurements to evaluate the quality of work outputs and processes
• Expresses concern about quality
• speaks up about practices that may compromise the quality of service
• Alerts others about potential problems or implications for plans or actions

Results Focus and Accountability: (Level 2 – Tactical Lower)

• Puts in extra effort (above what would normally be required) to accomplish a goal
• Takes on-going, repeated action to overcome obstacles to goal achievement
• Looks for and identifies better, faster, less expensive, or more efficient ways to achieve results
• Continuously monitors progress towards goal achievements, and acts decisively when progress is stalling
• Willingly takes on difficult assignments

Teamwork/Collaboration: (Level 2 _ Tactical Lower)

• Solicits the input of team members and encourages their participation
• Ensures participation of others who are affected by plans or actions
• Puts team’s agenda and the good of the whole ahead of personal needs
• Finds areas of agreements when working with conflicting individuals or groups
• Supports and acts in accordance with final group decisions even if such decisions may not reflect entirely one’s own opinion
• Helps others to solve work problems and achieve team objectives

Written Communication: (Level 2 – Tactical Lower)

• Organizes moderately complex written work that is clear and easy to follow
• Writes in a manner that expresses the intention and achieves desired results
• Uses vocabulary and sentence structure that is appropriate to the context and the audience
• Develops and uses graphics, as appropriate, to convey content 

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Description

ABLE TO UNDERTAKE ALL OF THE RESPONSIBILITIES BELOW

Product registration

• Conduct due diligence on received change controls, variation packages, and dossiers pertinent to, but not restricted to, LCM of the assigned product portfolio.   
• Compilation of dossier modules related to submission of variations and/or SAHPRA responses when not supplied by third party stakeholders.
• Identify and maintain updates on registered products based on SAHPRA guidelines and allocated priorities.
• Assist in review and sign off of submissions compiled by Regulatory Scientists.
• Interact on a regular basis with PD departments, overseas affiliates, third parties and contractors on necessary regulatory activities.
• Liaise with SAHPRA on behalf of Pharma Dynamics on new and existing queries, as and when required.
• Compile and submit all responses to SAHPRA recommendations, Safety Updates and variations, within agreed and specified time limits.
• Maintain the department’s online apps (eg. CCP database, docuBridge, AW app etc) as per official SOPs and/or working instructions.
• Assistance with the artwork process to finalise printed packaging components in submitted countries in line with Act 101 and the Marketing Code.
• Supervise/manage/coach staff complement and related activities, if/when necessary

General

• Perform any other duties as per changes in operational requirements of the department.
• Perform any other duties as requested

Technical /Compliance activities

• Manage and monitor the Change Control Process effectively
• Liaise with SAHPRA on registration status and technical queries
• Assist with technical queries internally and with the guidance of line management, externally, as/when necessary.
• Assist with answering relevant Pharmacovigilance and Technical queries, as/when necessary.
• Assists with review and approval of batch release documents, as/when necessary.
• Assists with periodic internal audits, as/when necessary. 

Packaging material

• Review and facilitate approval of printed packaging components
• Ensure all printed material, complies with the Marketing Code of Conduct and SAHPRA requirements

Document management

• Ensure the EDMS is current and up to date and in line with submitted dossiers.

Requirements

PRE-REQUISITES

• B. Pharm registered with the SA Pharmacy Council
• Minimum of 2 – 3 years Regulatory hands-on experience, within the pharmaceutical industry.
• Able to perform all standard registration processes under specialist guidance

COMPETENCIES

Initiating Action and taking initiative: (Level 1-2 _ Operational / Tactical Lower)

• Demonstrates drive and energy in performing the job.
• Recognizes and acts on opportunities to address present problems and sees what needs to be done.
• Acts without being told or forced by events; is self-directed.
• Responds to situations or opportunities with appropriate sense of urgency.
• Works to achieve more than average results.
• Willing and eager to seek out and accept new challenges.

Resilience and Tenacity: (Level 3 – Tactical Higher)

• Tackles difficult and complex problems and takes personal responsibility and accountability for reaching solutions.
• Remains determined despite frequent obstacles.
• Maintains enthusiasm of others after disappointment or rejection.
• Bounces back very quickly.
• Leads others through dealing with disappointment/rejection.
• Re-engineers or creates new processes and systems to get around obstacles.
• Anticipates problems and proactively designs contingency plans.

Professional Knowledge and Skills (Level 3 _ Tactical Higher)

• Thorough understanding of the knowledge / skill area.
• Effectively applies a broad range of principles, practices and procedures in the knowledge / skill area.
• Is sought out by others for advice for the resolution of difficult problems.
• Can work independently.
• Keeps up with current developments in area of expertise.

Information Management: (Level 1 - 2_ Operational/ Tactical Lower)

• Aware of the knowledge and information relevant to their roles and the value this brings to the company.
• Reviews and communicates gaps in knowledge and information which hinder the achievement of objectives.
• Shares knowledge and information appropriately and participates in activities to facilitate sharing.
• Understands and complies with information management standards and guidelines.
• Effectively uses standard retrieval and distribution tools.
• Uses appropriate knowledge and information resources.
• Complies with information confidentiality and security standards.
• Contributes to the development of processes, tools and standards.

Written Communication: (Level 2 _ Tactical Lower)

• Organizes moderately complex written work that is clear and easy to follow.
• Writes in a manner that expresses the intention and achieves desired results.
• Uses vocabulary and sentence structure that is appropriate to the context and the audience.
• Develops and uses graphics, as appropriate, to convey content.

Analytical thinking/Problem Solving: (Level 2 _ Tactical Lower)

• Adjusts to work effectively within new work structures, processes, requirements, or cultures.
• Views change as an opportunity to improve.
• Willing and eager to change.
• Actively seeks out positive spin-offs of change and investigates ways in which change can be used.
• Anticipates change and continuously remains prepared for change.
• Demonstrates resourcefulness in acquiring necessary knowledge, skills and competencies to adapt to change.

Planning and organizing/ Work Management: (Level 2 _ Tactical Lower)

• Plans and implements moderately complex activities/projects.
• Clearly defines objectives and translates them into workable activities.
• Plans with a realistic sense of the time and resource demands involved maintaining awareness of the interrelationships between own and other activities/project.
• Anticipates potential obstacles and their impact on the accomplishment of goals and timelines.
• Uses time and resources effectively to accomplish desired results.
• Monitors and tracks progress to ensure delivery of all planned commitments, and keeps the appropriate people informed.

Results focus: (Level 2 _ Tactical Lower)

• Puts in extra effort (above what would normally be required) to accomplish a goal.
• Takes on-going, repeated action to overcome obstacles to goal achievement.
• Looks for and identifies better, faster, less expensive, or more efficient ways to achieve results.
• Continuously monitors progress towards goal achievements and acts decisively when progress is stalling.
• Willingly take on difficult assignments.