Key Role Specific Requirements:
- Ensures that the Quality Control team supports all production shifts with in-process testing, and overseeing Raw material testing and scheduling to support production activities
- Oversees postproduction finished product testing and specifications are completed to support disposition of product. Supports resolution of deviations and OOS in accordance with company SOPs.
- Assists in the preparation for Health Authority inspections and audits and provides support to their execution and follow-up.
- Leads by example and proactively communicates and collaborates with internal staff, colleagues, and external stakeholders to drive results.
- Achieves results through direct reports by communicating job expectations & company vision; establishing individual goals in line with corporate/departmental objectives, coaching, reviewing performance results; holding accountable; providing training and skill development opportunities for growth and improved performance.
- Leads in the investigations regarding batch discrepancies, non conformances and out-of-specification events to evaluate impact on product quality and ensure corrective action and non-recurrence.
- Development and updating of SOPs, validation protocols, validation reports and method validation / verifications and equipment qualifications.
- Develop and maintain quality systems within the laboratory to ensure ongoing compliance with cGLP.
- Oversee calibration program for the lab and ensue timely completion.
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:
INTEGRITY/PERSONAL CREDIBILITY – Demonstrated ability and concern that one be perceived as responsible, reliable and trustworthy
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.
INITIATIVE - Identifying what needs to be done and doing it before being asked or before the situation requires it.
THOROUGHNESS/DETAIL ORIENTED – Ensuring that one’s own and others’ work ad information are complete and accurate; carefully preparing for meetings and presentations following up with others to ensure that agreements and commitments have been fulfilled.
PLANNING – is the process of thinking about and organizing the activities required to achieve a desired goal.
LEADERSHIP – is the ability of an individual to influence, coach or inspire followers or other members of the organization; to enhance others’ commitment to their work and to a high -performance culture. Provide motivational support, and the ability to develop and communicate goals in support of the business mission. Provide direction with purpose and alignment to Company vision and values.
- Bachelor’s Degree within a Scientific Discipline essential
- Minimum 5 years’ experience in GMP environment within a pharmaceutical (HPLC) environment.
- Minimum 2 years’ experience in a leadership role.
- Strong analytical/quantitative skills
- Excellent technical writing skills
- Good understanding of root cause analysis and its application
- Good computer skills with high proficiency in Microsoft Office a plus
- Thorough understanding of quality systems and cGMPs.
- Experience in defending processes, procedures and investigations during Regulatory inspections
- Customer Focus – takes personal responsibility for speed, quality and accuracy of delivery.
- Self-motivated, determined and able to work under own initiative
- Progressive – Pro- active approach to best practice within the QC function
- Collaborative – a team player who can mobilise managers cross functionally to deliver high quality standards
- Competitive – Self driven with a desire to be the best as an individual and as a business to deliver for our customers
- Ability to work under pressure in a challenging and fast-moving environment.
- Excellent oral and written communication skills
- Thoughtful leader who understands the value of coaching and supporting their team to exceed expectations
- Problem solving ability using robust 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 optimize the health, wellbeing and productivity of the world’s animals.