Quality Compliance Director

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 Organization 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.

Department : Quality

Designation : Deputy General Manager

Role : Corporate Quality Assurance

Reporting to : Global Quality Head

Location : Turbhe (Navi Mumbai)

What you become a part of :

Deputy General Manager Quality To lead the team of quality professionals in CQA to review and approve documents, investigations, market complaints, CAPA, gap assessments, vendor management, technical trainings and support Inhouse sites for compliance etc. Ensure / comply with Shalina QMS systems in compliance with internal and regulatory requirements

What to expect :

• Review and approve change controls initiated by plants.
• Review and approve vendor qualification documents and ensure effective implementation of the vendor approval system.
• Monitor and ensure that all plants comply with cGMP, cGLP requirements and good documentation practices.
• Support to manufacturing site for investigation and regulatory audit compliance.
• Review and approve of CQA guidelines. Ensure that the CQA guidelines are in line with the regulatory requirement.
• Review and approve SOP of Corporate departments.
• Review and approve of change controls, deviations, protocols and reports, qualification documents, stability protocols and MFR / MPR of corporate department.
• Review and approval of relevant R&D documentation.
• Ensure quality agreements are in place with vendors, as per requirements.
• Ensure that detailed investigations are in place for out of specifications, market complaints, product recall, and stability failures and that appropriate CAPA is planned and executed as per the defined procedures.
• Ensure that all team members are trained and updated in line with regulatory requirements.
• Effective implementation of training policy.
• Ensure smooth transfer of technology for product transfers from one site to another.

Essential qualifications, experience, and skills :