Associate 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: Associate Manager CQA

Base location: Pawane, Navi Mumbai, India

Reporting to : Sr. Manager - Quality

What to expect:

• Handling of Change Control including review, evaluation, execution and post implementation checking along with tracking till action closure.
• Handling of Deviation including review, evaluation along with tracking till closure after completion of all recommended actions.
• Handling of Rejection of Loan license sites and own manufacturing sites including Destruction note creation in SAP, execution for approval of Rejection note and further tracking of rejection till physical destruction of material at location.
• Investigation of Market complaint with root cause identification till closure with effective implementation of identified corrective and preventive action.
• Monitoring of QMS related SOPs for effectiveness check and revision of SOPs for harmonization with any type of changes related to regulatory observation and ongoing process improvisation.
• To review the artworks, print proof and management of shade card.
• Conduct periodic quality audits for CTL & RM/ PM/ FP vendors, Self-Inspection, compilation of report & review of compliance.
• Any other task, cross function job assigned by Reporting Manager/Quality Head.

Required Skills & Experience

Qualification: B.Pharm/M.Pharm

Experience: 8 to 11 yrs., Skilled in QMS activities like Change control Management, Deviation management, CAPA, Complaint handling, Rejection handling and artwork management, SOP preparation

Competencies:

• Should be proficient in QMS activities of Oral Solid Dosage forms, Oral Liquids and External Preparations.
• Should be competent in MS-word, Excel & PowerPoint. SAP & QMS software handling experience will be beneficial