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Description
About Shalina Healthcare: We are one of the largest, privately owned pharmaceutical businesses across Africa (Global Head Quarters- Dubai, UAE) with recent forays across multiple, new lines of businesses, viz., Digital Healthcare, Diagnostics, Consumer Healthcare, etc. Over the last 40 years, operating across multiple geographies, we have made it our mission to provide quality medicines to those who need it the most. We manufacture and distribute branded prescription and over-the-counter pharmaceutical and consumer products, across a broad range of therapeutic groups, including anti-malarial, antibiotics, anti-inflammatory, respiratory, gastrointestinal, nutrition, oral care, dermatology, sexual well-being, and antiseptic liquids & soaps. Leading brands, great teams and a focus on influencing the well-being of people have made Shalina a household name in Africa. We have a track record few can match, and our brands are among the most trusted in Africa. We are proud of our history and have big ambitions for the future. Our vision for 2030 is to be the health champion of Sub-Saharan Africa. To achieve this, we are looking for the right people to join us and create a lasting impact not just within our company but on the communities that we serve; people who identify with our Core Values and are as passionate about our Mission as we are. 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: Preparation and adherence to annual planner for Quality audits for Loan licence Units (LLU), Third Party Manufacturing Sites to conduct periodic, due diligence & for cause quality audits to ensure GMP compliance and to monitor overall performance of the manufacturing. Preparation and adherence to annual planner for Quality audits for public testing laboratories & Shalina Operating units (OUs) to conduct periodic, due diligence & for cause quality audits to ensure GLP compliance and to monitor overall performance of the testing facility. Review of audit compliance report for any external/ regulatory/ customer audits received from location and to monitor closure of individual observations by reviewing relevant supporting data. To conduct self-inspections of individual departments, Compilation of report, tracking and review of compliance for timely closure. To ensure the all-time audit readiness of own manufacturing sites. Co-ordination for compilation and review of technical documents received from vendors for evaluation and arranging analysis of samples, comparative evaluation of results and maintaining all the technical records for each vendor as per SOP. Introduction, implementation and effectiveness checks for Quality management system (QMS) to all manufacturing site. Preparation for presentation of monthly quality review meeting (QRM) to present overall status of the section and to highlight any open issues which was not resolved within timeline. Co-ordination, tracking and monitoring of all QMS, Vendor Management and documentation related activities in absence of designee from respective section, if required. To conduct the training at periodic intervals on important quality aspects and to get awareness and updates on current guidelines and GMP requirements. To support other cross-functional teams for any technical inputs for implementation and maintaining quality system. Develop and implement vendor qualifications and onboarding processes in accordance with corporate quality standards. Conduct risk assessments and due diligence for new and existing vendors. Monitor and evaluate vendor performance through KPIs, scorecards, and regular reviews. Ensure vendors comply with agreed-upon quality, regulatory, and contractual requirements. Plan, schedule, and conduct internal and external quality audits, including vendor audits. Assess vendor compliance with applicable regulatory standards and internal SOPs. Prepare audit plans, checklists, and reports with clear documentation of observations and non-conformities. Follow up on audit findings, CAPA (Corrective and Preventive Actions), and ensure timely closure. Drive quality improvement initiatives across the vendor base. Recommend process improvements based on audit trends, risk analysis, and vendor performance data. Provide training and guidance to internal teams and vendors on quality and compliance expectations. Maintain audit records and ensure data integrity, traceability, and regulatory readiness. Skills Deep understanding of ISO (e.g., SAHPRA, PICs, WHO, ISO 9001, ISO 13485), GxP, GMP, FDA, ICH, or other applicable regulatory frameworks depending on the industry. Proficient in implementing, auditing, and maintaining QMS frameworks Ability to investigate non-conformities and identify systemic issues Strong writing skills for audit reports, SOPs, and compliance documentation Ability to interpret audit trends, compliance metrics, and performance indicators. Strong problem-solving mindset to assess data, detect patterns or risks, and draw meaningful conclusions. Deep understanding of relevant industry regulations. Effectively communicates audit findings and compliance issues across all organizational levels Perks and benefits Office Travel Show more Show less
