Key Responsibilities
- Report to Head Quality and Compliance regarding day today activities of company’s Quality Control department.
- Identify department staff requirement and recruit the employees for Quality Control.
- Provide support to the manufacturing operation during the execution of commercial batches with in the stipulated timeline.
- Ensure the investigation is closed on time and the quality trending is completed in stipulated timeline.
- Ensure a disciplined work environment aligned to the Quality Culture and to provide expertise to subordinate colleagues in the proper performance of laboratory procedure.
- Review and approve of method validation, method verification, cleaning validation, and qualification protocol and reports.
- Review and approve SOPs, process validation protocols, deviations, change controls, lab investigations and other QMS documents related to Quality Control.
- Ensure the compendia/supply driven changes are verified and completed on time to support the product supply.
- Provide support to conducting the stability study of commercial product, site transfer project to the organization.
- Ensure stability sample management and testing as per the procedures.
- Evaluate trends for stability samples, water samples, and initiate corrective action and if applicable follow up and report on quality improvement system.
- Responsible for the operation of all quality control laboratory in the company, including operation budget and resource management.
- Participate and support in USFDA audits and other regulatory inspections.
Candidate Profile
Key Skills
- Exhibited business acumen in understanding cross-functional processes, requirements, and relevant information flows, and translating gaps into solutions.
- Demonstrated strategic, process-driven, analytical, and critical thinking.
- Proven experiences in holding people accountable, developing cross-functional teams, and facilitating decision-making processes.
- Strong organizational, interpersonal and communication skills.
- Proven ability to lead, manage and motivate subordinates.
- Demonstrated interpersonal savvy and relationship management/networking skills.
- Strong ability to deal with ambiguity and manage through difficult situations.
- Proven ability to manage multiple, complex projects at the same time.
- Excellent ability to delegate and can effect change through others without direct involvement.
- Strong written and oral communication skills.
Qualification & Experience
- Master’s Degree in Science or Pharmacy
- Minimum 20+ years of professional related experience in Formulation pharmaceutical manufacturing environment and at least 10-12 years in managing the laboratory function.
- Experience in Pharmaceutical Manufacturing operations and controls change management processes, regulatory affairs, validation, leadership, influencing, and negotiation.
- Strong understanding of GMP requirements and their application in a manufacturing environment. Knowledge of international GMP requirements.
