Sr Manager QA SOP Management

Job Purpose

• To develop and manage the Corporate QA SOP team. Review and approved the change request and corporate documents like SOPs, CTGs, Policies, non-routine protocol, etc. for quality systems and processes in order to ensure compliance with all regulatory guidelines and current GxPs (GDP, GLP, GMP etc.).
• Establish and maintain a framework for corporate documentation (QA SOP) by harmonizing set standards across all manufacturing sites to ensure compliance to current regulatory requirements and cGMP standards.
• Monitor harmonization and simplification process of corporate documents across all units to reduce complexities in processes and ensure standardized procedures across all locations and strengthen QMS in accordance with cGMP.
• Design and approved the corporate documents to meet highest levels of quality standards.
• Impart training to team member.
• Ensure effectiveness check of SOP
• Provide support to cross factional team.

Education Qualification

M. Pharm/ B. Pharm / M. Sc. With chemistry specialization (Pharma degree preferable)

Relevant Work Experience

• 16 - 20 years experience, Working with Formulation and / or API manufacturing in pharma.
• Knowledge in drafting the documents using tools like CipDox, Excel, PowerPoint, and Word.
• Skillset includes decision making ability, good written and verbal communication skills, strong organizational skills and ability to review/update processes and procedures.

Location

Vikhroli, Mumbai