Careers | Dr Darwin

We at Dr. Darwin are inspired by our purpose of 'Caring for Life' and strive to extend this philosophy to our associates and their families. Our endeavour is to build a high-performance and meritocratic work culture with care as the cornerstone.

Culture

At Dr. Darwin, we have found strength in our diversity, imbued by our culture of mutual respect, empathy, and adhering to the highest ethical standards. Our approach and culture is represented through Sunology: the Darwin way of life. Humility, Integrity, Passion & Innovation together form Sunology – a combination of two words, Sun & Ideology.

We encourage our employees to personify these ideologies, as they form the cornerstone of everything we create and value as an organisation. We are proud that our global workforce is bound together by our common values of quality, reliability, consistency, trust, and innovation. These values form the core of our culture and steer us towards our vision.

We attribute our growth and success to our strong multi-cultural workforce from different nationalities. Our team has taken Dr. Darwin to the heights that it has scaled and are now working to take it further up on its high growth trajectory. Our people are our most valuable asset. Our culturally diverse workforce is one of our biggest strengths and the rich experience they bring, across varied skill-sets and backgrounds, is invaluable. We are proud that our global workforce is bound together by our common values.

Experience Required: 5 years

Key Competencies:

Passion for Excellence
Leadership & Team Management
Result Orientation & Multi Tasking
Good Communication Skills
Head Quality is accountable for ensuring the all-time readiness of plant for various GMP compliance audits, being the single point contact on all Quality matters.

Quality Assurance:

Develop, implement, manage, audit and maintain GMP quality systems.
Coordinate and perform all vendor qualification and compliance audits.
Develop, manage and maintain a GMP compliant document control system.
Oversee investigations of all non-conformances (deviations, errors etc.).
Ensure that cGMP requirements and quality standards are recognized, understood and maintained across the Company.
Work across all disciplines (e.g. manufacturing, warehouse & QC, etc.) to ensure that the Company maintains a state of readiness for inspection by regulatory agencies.
Keep abreast of changes to quality regulations and guidelines, advising the management team of any business implications of these changes. Lead, manage and ensure proper training to any relevant change management programs throughout the company.
Provide quality guidance to product development projects and programs.
Maintaining and improving departmental operational performance, to meet the requirements of regulatory authorities, company Standard Operating Procedures (SOPs) and external and internal customers, with respect to quality, service, lead time and cost.
Ensuring the development of departmental SOPs (writing, revising and approving), ensuring regulatory compliance in conjunction with being - fit for purpose- operationally and commercially.
Ensuring that all activities are performed in accordance with GMP, company SOPs and Health and Safety policies.
Ensuring that there is a self inspection programme in place which is communicated to Operations to meet the requirements of cGMP guidelines.

Quality Control:

Managing all validation activities, including validation strategy and approval of protocols and reports.
Develop, communicate & adhere to best Testing practices to ensure that no non-conforming batch leaves Company premise
Ensure qualification & maintenance of equipment's, department & premises.
Ensure optimum utilization of the resources available so as to comply with the agreed timelines with customers, internal & external.
Ensure - ZERO- down-time for want of maintenance of machines, manpower & material
Observing and complying with GLP.

Management:

High level resource planning.
Represent QA at senior management, project, Board, and review meetings.
Providing direction and guidance to the Quality team.
Managing, motivating, coaching and mentoring direct reports, to higher levels of management capability.
Identifying and developing the Quality team structure.
Preparing and justifying the Quality department's budget.
Ensuring good relations and communications with all members of the team and responding politely and in a timely fashion to internal and external customers.
Undertaking any other duties, either for this department or any other department within the business, which may be requested by the Line Manager, for which training and/or an explanation has been provided and understood.
Budgetary and managerial responsibility for Quality Assurance and Quality Control.

Person Profile:

Scientific degree (ideally pharmacy, pharmaceutical sciences, chemistry or related).
Quality professional with 10+ years of hands on experience with increasing responsibility in a QA function.
Prior responsibility for Quality Control (preferred).
Hands on experience implementing quality systems in a GMP environment, and direct experience with FDA and other health authority inspections.
Extensive knowledge of various GMP compliances regulations and industry practices.
Ability to critically evaluate and troubleshoot complex problems is essential.
Strong hands on leadership and management skills with a - can do- attitude.
Ability to effectively participate on multi-disciplinary teams.
Ability to absorb, digest and relate detailed scientific, quality, and regulatory information.
Well-organized and detailed oriented professional, with strong verbal and written communication skills.
Strategic thinker with the ability to influence at a senior level.
Highly customer focused.
Commercially astute.
Strong analytical and problem solving ability.
Excellent project management skills.
Adept at Conflict Management & resolution