Quality Assurance Executive

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/

What to expect:

• Monitoring of Loan License Site located in Navi Mumbai, Mahape, Palghar & Vadodara region.
• IPQA/Shop floor activities monitoring - Tablets, Capsules, Oral Liquids, External and Sterile formulations etc. (Preferred External preparations and Oral Liquid formulations)
• Quality Oversight at Loan License Sites and tracking for closure of actions.
• FG Inspection, Review of batch records and Batch releases.
• Site pre-assessment for regulatory inspections as per GMP requirement.
• Investigation of any non-compliance in co-ordination with LLU Site and tracking closure of CAPA.
• Review and COA and analytical data before release of finished product from LLU Site.
• Review of Finished product related data to support new product Launch.
• Process Validation and Stability study execution and data review at LLU.
• APQR preparation, Witness manufacturing and analysis of finished product.
• Quality Audits of Contract Manufacturers & compliance review
• Overall LLU Management & co-ordination.

Preferred candidate profile

• 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.

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