Reporting to the QA Supervisor, the Quality Assurance Intern will support the processing of GMP-controlled documentation in alignment with departmental goals and timelines. This role requires strong attention to detail and basic proficiency in Microsoft Office applications.
In addition to managing documentation, this position will receive cross-training to assist with incoming inspections of components, providing essential support as needed. This role will collaborate with various functional groups to help achieve business objectives and maintain compliance with regulatory standards.
The ideal candidate will demonstrate exceptional attention to detail, a proactive approach to efficiency, and a commitment to upholding current cGMP procedures and quality practices. This role supports the broader compliance and quality teams, contributing to continuous improvement efforts and aligning with the company’s strategic goals, vision, mission, and values.
Key Role Specific Requirements:
Maintenance of Quality Assurance documentation control system including the preparation, Registration, Distribution, and upkeep of all controlled documentation including specifications, procedures, batch cards, listings etc.
Issuing of all GMP documentation to departments where required.
Co-ordination of packing specification process including initiating of packing specification change requests
Performs reviews of the quality systems (change control, deviations, audit etc.)
Participate, plan, and coordinate the internal auditing schedule, reports and CAPA closures.
Supports the Auditing process as required.
Responsible maintenance of QA Databases, typing of all department documentation including but not limited to SOP, packaging specifications, and the filing of all QA related documentation including retain documentation and batch cards.
Maintenance of the documentation archive / retains area and the review of QA Documentation as requested by the QA Supervisor.
Carrying out tasks as requested by the QA Supervisor.
Maintenance and coordination of BAHL departmental requests from QA support.
Conducts QA Batch Review as required:
Supports the team when required with incoming inspections.
Completion of other activities that may be required as requested by the QA Supervisor
Please note that this job description is not exhaustive, and the role holder may be required to undertake other relevant duties commensurate with the grading of the post. Activities may be subject to amendment over time as the role develops and/or priorities and requirements evolve.
Competencies Required for the Role:
ADAPTABILITY/CHANGE AGILITY – Is the ability to be agile and adapt to constant change; shows good resistance to pressure and stress; is resilient and open-minded. The ability to demonstrate support for innovation and for organizational changes needed to improve the organization’s effectiveness, initiating, sponsoring, and implementing organizational change. The ability to change or be changed in order to fit or work better on some situation or purpose and embrace change. Strives for continuous improvement.
INITIATIVE - Identifying what needs to be done and doing it before being asked or before the situation requires it.
FOSTERING COLLABORATION/TEAMWORK- is the ability to work jointly with others or together especially in an intellectual endeavor; the ability and desire to work cooperatively with others on a team; as a team leader, the ability to demonstrate interest, skill, and success in getting groups to learn to work together. Builds partnerships for global performance. Respects others.
ENGAGEMENT, DRIVE AND EMPOWERMENT - The ability to convey confidence in employee’s ability to be successful, especially at challenging new tasks; delegating significant responsibility and authority to engage employees; allowing employees freedom to decide how they will accomplish their goals and resolve issues.
EFFECTIVE COMMUNICATION - Is the ability to convey information to another effectively and efficiently, to listen – to help facilitate sharing of information between people. It is about understanding the emotional intention behind the information. The ability to express oneself clearly in conversations, confirm understanding, communicate using data and facts whilst adapting to one’s audience. Exhibit willingness to listen and show respect for oneself and others in interactions with others. express oneself clearly in verbal and business writing.
Other Requirements:
Degree level within a Scientific/Pharmaceutical Discipline (essential)
Previous knowledge/experience with GMP (desirable)
Previous QA administration experience desirable
Ability to work under pressure in a challenging and fast-moving environment.
Excellent communication skills
Strong interpersonal skills
Good Attention to detail
Knowledge of Pharmaceutical Manufacturing
Knowledge of Pharmaceutical Packaging
Knowledge of GMP
Proficient in the use of MS Office tools
Bimeda is a leading global innovator, manufacturer and marketer of veterinary pharmaceuticals and animal health products and has over half a century’s experience in providing science-driven solutions to optimise the health, wellbeing and productivity of the world’s animals. Bimeda’s global innovation programme sees six state-of-the art R&D centres across four continents collaborate on an enviable product development pipeline which anticipates the ever-evolving needs of the animal health industry. Bimeda’s nine manufacturing facilities across seven countries allow the company to manufacture a broad range of preventative, curative and nutritional products including sterile injectables, vaccinations, nutritional boluses, feed additives, tablets, water-soluble powders, pastes and non-sterile liquids. Globally, the company focuses on the development, manufacture and commercialisation of quality Bimeda-branded products while also being the partner of choice for contract manufacturing and R&D services for prominent companies within the animal health industry.
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