Assistant Manager - Quality (External Quality)

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:

• Monitoring of Contract manufacturers of Rest of India region
• (Except North and West India)
• Quality Oversight at Contract manufacturing sites.
• Regional representative for Rest of India for overall Quality compliance
• FG Inspection, Review of batch records and Batch releases
• Review of Finished product related data to support new Third Party Launch
• IPQA - Tablets, Capsules, Oral Liquids, External and Sterile formulations etc.
• Monitoring of all shop floor activities covering OSD, Oral Liquid, External and Sterile products.
• Process Validation and Stability study execution and data review
• APQR preparation, Witness manufacturing and analysis of finished product.
• Quality Audits of Contract Manufacturers & compliance review
• CMO Management & co-ordination

Preferred Candidate:

• 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.

Qualification:

• B. Pharmacy
• M. Pharmacy
• Or any science graduate with relevant experience

Competencies:

• Thorough Knowledge of shop floor of OSD & Sterile formulations
• Handling of contract manufacturers