PYMEPHARCO

Job Description

ESSENTIAL DUTIES

• Manages and provides leadership for the Quality Control’s development, direction, and effectiveness, adhering to organizational policies and processes and supporting overall business and corporate objectives.
• Develops and maintains policies, programs, and strategies to ensure continuous full compliance with relevant EU-GMP, US FDA, Pharmacopeias, and ISO requirements.
• Effectively plans and execute QC capacity strategy to accommodate and excel in company’s compliance and business targets.
• Communicates performance expectations and business and corporate policies to section staff and others.  Ensures accurate and complete associate records are maintained within the section. Coaches and develops local QC team to ensure business continuity and sustainable people development.
• Develops and justifies Capital Expenditure Requests and Corporate policies to support goals and mission objectives.
• Provides continuous oversight and guidance, and systematically monitors the optimization projects within QC to ensure successful continuous improvements
• Ensures QC Tech Transfer projects are appropriately managed and resourced;
• Working with local leadership, develops preliminary section budgets, goals, objectives, and operations that will be integrated into the full department budget.
• Responsible for the QC department KPIs and addresses unmet targets appropriately.
• Interprets, monitors regulatory requirements in Chemical, physical, and microbial testing.
• Manages the team’s workload, projects arrangement, QC activities relevant to product transfer and testing support for validations and others.
• Develops strategies to assess and mitigate cross-contamination risks within QC responsibilities.
• Actively works to identify new and expanding areas of contribution for the lean processes and utilization of technologies
• Routinely updates and reports to Site Quality Head on emerging issues, changes relevant to overall strategic direction.

OTHER DUTIES AND RESPONSIBILITIES

• Will be responsible for all technical assessment on microbial aspects of production and control necessary to ensure the sterility of relevant manufactured products.
• May contribute as a member of the business regulatory compliance team.
• Reviews physical and equipment requirements for the laboratory.  Regularly assesses short and long term needs and prioritizes equipment acquisition.

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MINIMUM QUALIFICATION REQUIREMENTS

Education

• Bachelor’s degree in Pharmacy, Biology, Chemistry or equivalent education and experience sufficient to successfully perform the essential functions of the job.
• A Master’s degree in Pharmacology or related discipline is preferred.

 Experience

• Minimum 12 years progressive management experience in pharmaceutical QC Lab at a globally recognized organization
• Proven track record in managing large team with completing priorities and developing sustainable and growing QC team.

Skills

• Demonstrated effective leadership and managerial skills.
• Ability to manage complexity of QC projects and compliance responsibilities
• Demonstrated knowledge in applicable regulations affecting areas of responsibility.
• Comprehensive knowledge of the principal chemical, physical and microbial testing
• Strong leadership skills and demonstrated successes in managing a medium to big-sized team (50-70).
• Excellent and effective verbal and written communication skills in English
• Success with working with multifunctional teams: Global and local
• Comprehensive knowledge of EU-GMP, US FDA, and international regulations relevant to pharmaceutical industry and to Quality Control and Quality Assurance.
• Ability to succeed in a team-oriented atmosphere and lead team activities.
• Working knowledge of Lean methodologies such as 6-sigma, OpEx.
• Understanding of applications and limitations of testing methodologies.
• Knowledge and use of relevant PC software, Lab software applications and skills to apply them effectively.

All contact information:
+ Candidates please apply directly at the address: 166-170 Nguyen Hue, Ward 7, City. Tuy Hoa, Phu Yen
+ Either by post to the Human Resources Department, or by email: tuyendung@pymepharco.com
+ For more information please call: 02573 829 165 (Linh Nhu/ HR Dept.)