Position: Technical Services Manager
Department: Technical Services Department
Reports to: Plant Manager
Directly Supervises : QC Manager, QC Supervisor, QC Analyst, QC MicroAnalyst, QA Supervisor, QA Inspector, Document Control Officer, R&D Officer, R&D Formulator, Lab Aide
Provide technical leadership, direction and management of the Quality Services and Research & Development teams. Demonstrate, understand and implement quality in product and process development. Establish goals that are consistent with the department, implement plans and policies, assigns duties and responsibilities and control team performance to ensure and improve the level of compliance with PUPC policies and procedure as well as cGMPs.
SPECIFIC DUTIES AND RESPONSIBILITIES
1. Set the strategic direction of the department. Manage day-to-day operations of multi
disciplinary projects to ensure performance within the agreed timelines, budget and according to the required specifications.
2. Manage and monitor performance of Research and Development team members and
lead the projects. Report and discuss status of Product Development.
3. Plan and manage successive phases of developmental and transfer activities including
production of research, scale-up, component changes and process validation batches.
4. Manage Quality Control and Assurance team members and ensure that processes comply with Good Manufacturing Practice standards.
5. Reevaluate the Quality System as part of continuous improvement; track and trend quality
metrics, deliverables, highlights/lowlights, areas of risk, in order to ensure processes and
procedures are in accordance with internal and FDA requirements.
6. Drive inspection readiness activities to support Quality audits by regulatory authorities.
7. Ensure the completion of internal audits of the Quality System. Ensure completion of audits
of vendor/suppliers, testing laboratories, GMP service providers;
7.1 Perform audits as required; ensure management of internal audit schedules, approved
7.2 Tracking of audit responses and implementation of corrective action plans
8. Set up, manage and keep up-to-date the Production batch records in accordance with cGMP
in such a way that any relevant information can be presented promptly during internal or
9. Responsible for Batch release. Final reviewer and verifier that all batch record is complete.
Determine if a final product can be released and distributed based on, submitted test data and thorough review of production documentation.
10. Approve all laboratory results, investigations, protocols and test procedures.
11. Coordinate the activities within the company to manage production schedules ensuring the
highest quality standards, and safety issues.
12. Establish system, manage and monitor Annual Product Review/Annual Report Compliance.
13. Mentor and coach team members, facilitating and assisting in their growth within PUPC.
14. Maintain strict confidentiality of information.
15. Perform other duties which may be assigned by the Plant Manager, for which training and/or an explanation has been provided and understood.
Education and Training : BS (MS/PhD desirable) in scientific field; preferably in Life sciences, pharmacy or engineering.
Work Experience Requirements : Ten (10) + years’ experience in the Pharmaceutical industry, with at least three(3) years in a Managerial position. Previous related work experience in formulation/process and/or analytical service groups.
Skill/Knowledge & Other Requirements : Demonstrated ability to work independently to manage complex projects with multiple priorities in a fast-paced, team-based environment. In-depth technical understanding of pharmaceutical development, testing and manufacturing processes. Excellent knowledge of pharmaceutical regulations, GMP requirements and Quality System Management. Excellent written and verbal communications. Good moral character.