Job Description :
Purpose : Team Leader Engineering Compliance the role holder is responsible to coordinate the E-compliance & Engineering Compliance activities to ensure a systematic step wise improvement plan is in place and followed.
The role holder is responsible for approval of Calibration Certificates, and Lead E-Compliance team for CSV activities of IT systems.
Act as QM for all external area engineering deviations (not in facility premises). Moreover, the core deliverables & responsibility is to maintain all VMPs and SMF, responsible for final approval for extensions as per the LSOP for CAPA Management for engineering activities and participate in cross functional team for Deviation management process.
Key responsibilities & Accountability : Key responsibilities & key result areas The role holder is responsible for approval of Calibration Certificates.
Act as QM for all external area engineering deviations (not in facility premises) Accountable to lead E-Compliance team for CSV activities of IT systems Maintain all VMPs and SMF Responsible for final approval for extensions as per the LSOP for CAPA Management for engineering activities Participate in cross functional team for Deviation management process Weekly reporting for engineering compliance state, & reports on compliance testing, developments, and processes.
Create Continuous Improvement Framework for Engineering Compliance. Ensure the company's compliance with applicable laws and regulations.
Conduct tests and studies into the company's product compliance. Assist in planning best-practice procedures for compliance and risk mitigation.
Explain and define compliance protocols and measures to stakeholders and relevant authorities. Advise management on compliance-related matters.
Update job knowledge by participating in educational opportunities; reading professional publications; maintaining personal networks.
Accomplish goals and organization mission by completing related results as needed. Identify deficiencies in skills among sales associates managed, and work to improve individuals’ capabilities through coaching, development, and training.
Drive the relevant soft skills including continuous improvement, and team building activities. Maintain and promote a teamwork environment with effective and clear communication amongst colleague.
Core Competency Solid Technical knowledge with strong implantation, and influencing skills. High on communication and collaboration, having an ability to manage multiple stakeholders at a time In terms of competency you are highly result oriented with strong sense of accountability & ownership.
A Dynamic Leader with strong aptitude and should be master of technical knowledge. In-depth knowledge of the industry's standards and regulations guidelines excellent knowledge of reporting procedures and record keeping Must be able to manage tasks and priorities and easily adapt to changing situations.
Ability to create cross functional relations and manage conflicts. Problem Solving and high agility on taking right scientific decisions Qualifications : - Education 4 years Bachelor in electrical / Mechanical / Mechatronics Engineering / any discipline in same field.
Master degree is a plus. - Experience : At least 7 - 9 years of experience pharmaceutical industry sector with strong knowledge in Software testing basics.
Prior experience in handling similar role will ensure better fitment. - Training : Key Competencies : Excellent command in English (Communicating, writing and speaking).
Proficient in MS Microsoft office and computer knowledge. Proven track record in systems initiation and KPI design Proven experience in project implementation in GMP environment. Technical Competencies :