Role Objective:
A key objective of this profile is to ensure the effective planning, execution, and documentation of validation and calibration activities, in compliance with regulatory standards and internal policies. The role focuses on maintaining high-quality standards, managing internal and external audits, and ensuring adherence to ISO 13485 and other relevant quality management standards. Additionally, the role supports continuous quality improvement initiatives and ensures that validation activities align with business needs and regulatory requirements.
Desired Candidate Profile:
- Bachelor's or Master's degree in Engineering, Life Sciences, or a related field.
- A minimum of 6 years of experience in Quality Assurance within the medical device or pharmaceutical industry.
- Strong knowledge of validation processes, quality systems, and regulatory standards, such as MDD 93/42/EEC and ISO13485.
- Experience managing CAPA (Corrective and Preventive Action), conducting risk assessments, and handling internal/external audits.
- Proven ability to manage validation projects, including scheduling and team coordination.
- Excellent communication, organizational, and analytical skills.
Role & Responsibilities:
- Plan and execute validation and calibration activities according to the approved schedule, including HVAC, process, transport, sterilization, equipment qualification, and temperature mapping.
- Coordinate the preparation of PR, PO, material issuance, and service entries for validation-related activities.
- Provide training to relevant personnel on validation processes and artwork review.
- Review and compile validation reports from external agencies, ensuring timely approval and payment processing.
- Verify vendor agreements and certifications, ensuring timely renewals and regulatory compliance.
- Oversee and ensure the proper execution of QMS activities, including document management and software use (e.g., TrackWise).
- Participate in line clearance and IPQA (In-Process Quality Assurance) activities as needed.
- Prepare and review GMP (Good Manufacturing Practice) documents such as SOPs, protocols, and other required documents.
- Ensure adherence to ISO13485 standards and other relevant regulations.
- Collaborate with the regulatory department to provide validation and calibration documents as needed for regulatory submissions.
- Participate in internal and external audits, ensuring timely and accurate documentation submission.
- Manage PR initiation and closure in TrackWise for qualification and calibration activities.
- Prepare and execute equipment and utility validation documents as per schedule.
Functional Skills Required
- Expertise in Quality Management Systems (QMS) and validation processes.
- In-depth knowledge of MDR and other relevant regulatory frameworks.
- Strong proficiency in CAPA management, auditing, and risk assessment.
- Technical expertise in process, equipment, and product validation.
- Ability to manage multiple validation projects and meet strict deadlines.
Behavioral Skills Required
- Strong team management and leadership abilities.
- Excellent problem-solving and analytical skills.
- High attention to detail and a commitment to accuracy.
- Strong interpersonal and communication skills.
- Ability to collaborate effectively across teams and departments.
- A proactive approach to continuous improvement and maintaining high-quality standards.
Team Size to be Handle:
- Manage the team of 2-3 team members of Validation & QMS, reporting to AGM-QA.
Learn more at: https://www.biotechhealthcare.com
Biotech is an Equal Opportunity Organization promoting diversity while ensuring no discrimination on any ground, including gender, race, religion, age, sexual orientation, disability, etc.
Skills Required
trackwise , Risk Assessment, Auditing
