Job Purpose
The Specialist for OnePH Quality Assurance Operations (QAO) is responsible for ensuring compliance with the quality management system for secondary repacking release, returns upon delivery requiring QA assessment, Complaints Intake and verification of all documents on-site that are under QA oversight (i.e., calibration records, inspection reports requiring QA assessment).
This role is responsible for ensuring that all quality assurance activities align with business objectives, regulatory requirements, industry standards, client and customer requirements while fostering a culture of quality and compliance within the organization.
Responsibilities(Key Result Areas and the major activities that must be achieved)
Key Result Areas (KRA)
- Batch Release On-Time
- Batches released on time as per agreed lead time
- Complaint Intake on-time
Performance Measures (Quantitative/Qualitative)
- % of complaints reported within one business day or as per client requirement
- QMS and Dangerous Drug Guidelines Compliance
- % Compliance to QMS and regulations
Major Challenges (The major challenges the position faces in carrying out the job, how to overcome)
- Navigating and adapting to complex and frequently changing regulatory requirements in the pharmaceutical industry.
- Managing cross-functional teams to ensure consistent adherence to QMS protocols.
- Balancing compliance and operational efficiency, especially in high-pressure situations
- Balancing the needs of the business unit with the regulatory and compliance requirements of QA, Clients and Customers.
- Ensuring consistent communication and alignment between quality standards and various operational practices across business units.
- Navigating and responding to changing industry regulations and client and customer requirements, ensuring compliance at all times.
Operating Network (Operating system reflecting position's internal and extent context)
External Stakeholders
- Regulatory Agencies (DFA, DOH)
- Quality Assurance Teams of Clients, Customers, Suppliers and Vendors
- Industry Associations
- External Consultants
Internal Stakeholders
- Senior Management
- Distribution Operations
- Commercialization Teams
- Other Functions
Qualification and Experiences
Qualification and Education Requirements
- Bachelor's degree in pharmacy, Life Sciences, or related field
- Certification in Quality Management Systems (e.g., ISO 9001, ISO 13485) is preferred
Relevant Experiences
- A minimum of 2 years of experience in Quality Management Systems within the pharmaceutical or life sciences industry.
- Demonstrated experience in process improvement methodologies such as Six Sigma or Lean is highly desirable.
Minimum Requirements
Technical
- In-depth knowledge of GxP standards and regulatory requirements in the pharmaceutical industry.
- Strong analytical and critical-thinking skills to address quality issues effectively.
- Excellent leadership and interpersonal skills, with the ability to collaborate across departments.
- Strong communication skills, both oral and written, capable of conveying complex quality concepts to a variety of stakeholders.
- Proficient in quality management software and tools, as well as Microsoft Office Suite.
Managing Complexity
- Excellent communication, negotiation, and interpersonal skills, capable of building relationships and influencing stakeholders at all levels.
Leading Change and continuous improvement
- Strong analytical and problem-solving abilities, with a proactive approach to identifying and mitigating quality risks.
- Demonstrated leadership skills with a focus on collaborative problem-solving and a commitment to continuous improvement
