Assistant Manager - Quality Assurance

Company: SAVA Healthcare is amongst the fastest emerging pharmaceutical company in India with global reach to customers in Canada, Ukraine and the CIS, Asia, Latin America, Africa & FWA. With manufacturing units in Surendranagar, Malur and in near future in Indore holds various accreditations and produces wide variety of dosage forms across therapeutic categories.
Our GMP compliant, State of Art manufacturing facility for Tablet, Oral Dry Powder, Capsule, Nasal sprays, DPIs, Cream, Gel and Ointment formulations with dedicated manufacturing sections supported by In-House R&D Center, focuses on Formulation and Analytical Development with an annual turnover of more than 200 crores and manpower of 500+ employees engaged across locations. Job Location: Surendranagar Plant  Job Summary:We are seeking a dedicated and detail-oriented Quality Assurance (QA) Personnel to join our Pharma Manufacturing Plant. The ideal candidate will be responsible for ensuring that our manufacturing processes comply with regulatory standards and internal quality protocols. This role is critical in maintaining product quality, safety, and efficacy, and ensuring our products meet all required specifications before reaching the market.

Key Responsibilities

Quality Management System (QMS):

• Maintain and enhance the Quality Management System (QMS) to ensure compliance with GMP (Good Manufacturing Practices) and other regulatory requirements.
• Develop, review, and update quality assurance policies, procedures, and SOPs.

Documentation and Records:

• Ensure all quality-related documentation is accurate, complete, and maintained according to regulatory standards.
• Review and approve batch records, quality control reports, and other manufacturing documentation.

Compliance and Audits:

• Conduct internal audits and support external audits to ensure compliance with regulatory requirements and company standards.
• Prepare audit reports, identify non-conformances, and implement corrective and preventive actions (CAPAs).

Product Quality Assurance:

• Monitor and verify the quality of raw materials, in-process materials, and finished products through regular inspections and testing.
• Investigate and resolve quality issues, deviations, and complaints related to manufacturing processes and products.

Process Validation and Improvement:

• Participate in process validation activities to ensure manufacturing processes are robust and reproducible.
• Identify areas for process improvement and implement quality enhancement initiatives.

Training and Development:

• Provide training and guidance to manufacturing staff on quality assurance practices, GMP, and regulatory requirements.
• Stay updated on the latest industry trends, regulations, and best practices in quality assurance.

Risk Management:

• Conduct risk assessments to identify potential quality issues and implement strategies to mitigate risks.
• Monitor and analyze quality metrics to identify trends and areas for improvement.

Qualifications

Education:

• Bachelors degree in Pharmacy, Chemistry, Microbiology, or a related field. Advanced degree or professional certification (e.g., Certified Quality Auditor) is a plus.

Experience:

• Minimum of 7-10 years of experience in quality assurance within the pharmaceutical manufacturing industry.
• Strong understanding of GMP, regulatory requirements (e.g., FDA, EMA), and quality management systems.

Skills:

• Excellent analytical, problem-solving, and decision-making skills.
• Strong attention to detail and organizational skills.
• Effective communication and interpersonal skills.
• Proficiency in using quality management software and MS Office Suite (Word, Excel, PowerPoint).