Job Title- Quality Assurance Specialist
Location- Goa
Main Accountabilities:
- Ensuring that activities in his/her scope are conducted in compliance with applicable regulatory requirements.
- Ensuring compliance with Good Manufacturing Practices (GMP) and other relevant regulations.
- Conducting regular audits of production processes to identify and address potential quality issues.
- Collaborating closely with production to ensure quality standards are maintained throughout the product lifecycle; highly recommended to be located on the shopfloor.
- Managing and resolving quality-related issues in a timely and effective manner.
- Monitoring and analyzing quality performance metrics, implementing corrective actions as needed.
- Leading root cause analysis investigations for quality incidents and implementing preventive measures.
- Participating in internal and external audits and regulatory inspections providing support and documentation.
- Developing and implementing risk management strategies to mitigate potential quality issues.
- Fostering a culture of quality and continuous improvement across the organization.
Key Involvement in Decision Making Process
Key Roles (D,A,I):
- Request corrections when GMP rules are not respected (D)
- Prioritize quality and compliance objectives (A)
- Proactively implement remediation action from findings from internal and external audits related to quality issues (D)
- Request quality improvement initiatives and strategies (D)
- Identify discrepancies and corrective/preventive actions that need to be taken (D)
- Escalate to upper management any failure in GMP execution on shopfloor (I)
- Inform relevant stakeholders and team members of quality performance, corrective actions, findings, and preventive measures (I)
- Advise on how to present a topic and answer specific questions (A)
- Advise on risk management strategies and plans (A)
- Advise on initiatives to promote a quality-focused culture (A)
Requirements/Qualifications
Expected Experience
- 5-7 years of experience in quality assurance within the pharmaceutical industry.
- Bpharm/ Mpharm.
- Strong knowledge of Good Manufacturing Practices (GMP) and quality assurance principles
Expected Technical skills
- Ability to analyze complex data and identify trends, issues, and solutions
- High level of accuracy and attention to detail in all quality assurance activities
- Strong verbal and written communication skills for effective interaction with team members and regulatory bodies
- Proficiency in identifying problems and implementing effective corrective actions
- Ability to manage multiple projects simultaneously, ensuring timely completion and adherence to quality standards
Language
- Local language and English
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