One of our prestigious clients “Pharmaceuticals Company” is looking for “Quality Assurance (QA) Head”.
Desired work experience: 10 To 15 Years Minimum.
Qualifications: Master’s degree in pharmacy, pharmaceutical sciences, chemistry, or a related field. Advanced degree (e.g., PhD) preferred.
Location of job: Mahemdavad, Gujarat
Desired Profile of the Candidate:
As the Quality Assurance (QA) Head at Aan Group, he / she will ensure compliance with regulatory standards and maintain high-quality standards for pharmaceutical products across both manufacturing facilities: 1) Beta Lactam orals and 2) General orals/semisolids. Leading a team of QA professionals, you’ll oversee quality assurance activities and collaborate with other departments to implement robust quality systems and processes. Responsibilities include approving quality documentation, SOPs, and related documents, monitoring SOP compliance, approving validation protocols and reports, managing preventive maintenance activities and calibration/qualification arrangements, handling market complaints and product recalls, approving stability studies and vendor development programs, facilitating audits and inspections, and providing technical guidance to Production, QA/QC, and Utility/Engineering departments.
Job Description/Responsibilities
Compliance Management:
- Ensure compliance with relevant regulatory requirements such as EMA, FDA, and other applicable regulations
- Develop and maintain quality management systems (QMS) to meet regulatory standards
- Conduct regular audits and inspections to assess compliance and identify areas for improvement
Quality Systems Implementation:
- Develop and implement quality systems, policies, and procedures to ensure consistent quality across all operations
- Establish and maintain documentation systems for SOPs, batch records, and other quality-related documents
- Implement risk management strategies to mitigate quality-related risks
Product Quality Assurance:
- Oversee the quality control process for incoming raw materials, in-process materials, and finished products
- Conduct product quality reviews and investigations into quality issues or deviations
- Ensure that product specifications and quality standards are met throughout the manufacturing process
Team Leadership and Development:
- Lead and mentor a team of QA professionals, ensuring they’re trained and competent in their roles
- Foster a culture of quality and continuous improvement within the QA department
Collaboration and Communication:
- Collaborate with other departments such as production, regulatory affairs, and R&D to ensure alignment on quality objectives
- Communicate quality-related metrics, issues, and initiatives to senior management and relevant stakeholders
- Act as a liaison with regulatory agencies during inspections and audits
Qualifications:
- In-depth knowledge of regulatory requirements and quality standards applicable to pharmaceutical manufacturing (e.g., cGMP, ICH guidelines).
- Strong leadership and team management skills, with the ability to motivate and develop a diverse team of proffessionals
- Excellent communication and interpersonal skills, with the ability to effectively collaborate across departments and influence stakeholders at all levels
- Experience in implementing and maintaining quality management systems and leading quality improvement initiatives
- Strong analytical and problem-solving skills, with the ability to drive continuous improvement and problem resolution