Senior Quality Assurance Manager

About Shalina Healthcare:

Shalina Healthcare is one of the largest pharmaceutical companies in sub-Saharan Africa. For the last 40 years 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 and nutrition. 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 we serve.

Everyone in our company has a crucial role to play, and we are looking for people who identify with our Core Values and are as passionate about our Mission as we are.

The Global Supply Organisation is a multi-continental Function that comprises of the entire Value Chain from product conceptualization to delivery to the commercial front. Within the Global Supply Organization are included; Research & Development, Project Management, Manufacturing, Quality, Supply Chain Management and Logistics.

Role: Senior Manager CQA

Base location: Pawane, Navi Mumbai, India

Reporting to : Head - Quality

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 to conduct periodic, due diligence & for cause quality audits to ensure GLP compliance and to monitor overall performance of the testing facility.
• Preparation and adherence to annual planner for Quality audits for Shalina Operating units (OUs) to conduct periodic, due diligence & for cause quality audits to ensure GDP compliance.
• Planning of audits as per approved audit planner, Review of audit outcome and preparation of audit reports and co-ordination with vendors for compliance within timeframe.
• 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 initiate the actions based on audit findings and compliances reviewed from location for approval, rejection and conditional approval of the manufacturing/testing facility.
• 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 Shalina laboratories 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 Shalina 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 of Shalina laboratories Private Ltd.
• Any other specific work assigned by Global Head - Quality.

Required Skills & Experience

• 12+ years of experience in Quality
• Qualification: B. Pharmacy or M. Pharmacy Or any science graduate with relevant experience
• Thorough Knowledge of shop floor of OSD, External, Oral Liquid & Sterile formulations Handling of contract manufacturing Sites.

Competencies:

• Candidate should have good exposure to GMP environment and regulatory inspections.
• Candidate should be flexible for business travelling across India & Overseas Locations.
• Candidates working on Shop floor and should have good GMP/GLP exposure.
• Independent and Candidates who able make to decisions online.
• Cross functional working and good ability to communicate with external stakeholders.