Senior Executive Quality

About Shalina Healthcare: Shalina Healthcare is among the largest privately owned pharmaceutical businesses in Africa with its Global Headquarters based in Dubai, UAE. The company has recently diversified into new lines of businesses such as Digital Healthcare, Diagnostics, and Consumer Healthcare. Shalina Healthcare has a remarkable track record and its brands are highly trusted across Africa. With a vision to become the health champion of Sub-Saharan Africa by 2030, the company is seeking individuals who can contribute to its growth and make a positive impact on the communities it serves. If you share our Core Values and are passionate about our Mission, we welcome you to join us on this journey. Website: http://www.shalina.com/ Department: Corporate Quality Qualification: M Pharmacy / B Pharmacy Designation: Senior Executive - Quality (Audit and compliance) Role: Vendor Quality Audit Reporting to: DGM- Corporate Quality Assurance Location: Turbhe (Navi Mumbai) What to expect: As a Senior Executive - Quality (Audit and compliance) at Shalina Healthcare, you will be responsible for the following key tasks: - Preparation and adherence to annual planner for Quality audits for Loan license Units (LLU), Third Party Manufacturing Sites, public testing laboratories & Shalina Operating units (OUs). - Reviewing audit compliance reports for external/regulatory/customer audits and ensuring timely closure of observations. - Conducting self-inspections, compiling reports, tracking compliance, and ensuring audit readiness of manufacturing sites. - Coordinating technical document evaluation from vendors, conducting training on quality aspects, and supporting cross-functional teams for quality system maintenance. - Developing and implementing vendor qualifications and onboarding processes, monitoring vendor performance, and ensuring compliance with quality and regulatory requirements. - Planning, scheduling, and conducting internal and external quality audits, following up on audit findings, and driving quality improvement initiatives. - Providing training and guidance to internal teams and vendors on quality and compliance expectations. Skills Required: - Deep understanding of ISO, GxP, GMP, FDA, ICH, or other regulatory frameworks. - Proficiency in implementing, auditing, and maintaining Quality Management Systems. - Strong problem-solving skills and ability to investigate non-conformities. - Excellent writing skills for audit reports, SOPs, and compliance documentation. - Ability to interpret audit trends, compliance metrics, and performance indicators. - Effective communication of audit findings and compliance issues across all organizational levels. Perks and Benefits: - Office Travel opportunities. Join Shalina Healthcare and be a part of our journey towards becoming the health champion of Sub-Saharan Africa by 2030.,