About this role
The team is seeking a highly experienced QA Head to lead their quality assurance efforts in the API pharmaceutical sector in Ankleshwar. This role is crucial for ensuring compliance with regulatory standards and maintaining the highest quality in product development.
Key Responsibilities:
- Oversee the preparation and implementation of Standard Operating Procedures (SOPs) related to quality assurance.
- Ensure knowledge and adherence to all regulated guidelines and pharmacopoeia.
- Manage the justification of specifications and documentation for regulatory filings.
- Address nitrosamine, elemental, and genotoxic impurities in relation to Drug Master File (DMF) submissions.
- Collaborate closely with the Quality Control (QC) team to ensure laboratory testing meets required specifications.
- Conduct regular internal audits of manufacturing processes to ensure compliance with quality standards.
- Lead and mentor the QA team, fostering a culture of continuous improvement and compliance.
Required Skills & Qualifications:
- Bachelor's degree in Pharmacy, Chemistry, or a related field; a Master's degree is preferred.
- Extensive knowledge of pharmaceutical regulations and quality assurance practices.
- Proven experience in the API pharmaceutical industry, particularly in a leadership role.
- Strong analytical skills and attention to detail.
- Excellent communication and interpersonal skills.
Experience:
- A minimum of 8-10 years of experience in quality assurance within the pharmaceutical industry, with at least 3 years in a managerial role.
What we offer:
- An opportunity to lead a dynamic QA team in a growing organization.
- A collaborative work environment focused on professional development and continuous improvement.
- The chance to make a significant impact on product quality and compliance.
Applications are read by our talent team, usually within two working days.
If you look like a fit we will call you, and you will hear from us either way.