Shalina Healthcare is a market leader in making quality healthcare and pharmaceutical products affordable and available across Sub-Saharan Africa. We achieve this by sourcing globally from WHO approved production facilities and by focusing on our first-class distribution expertise.
Shalina Healthcare has more than 40 brands and 250 products across more than 15 therapeutic areas. Our heritage is in prescription and OTC products; however we have diversified into consumer products and hospital supplies in recent years. The Shalina product range covers many therapeutic groups including analgesics, antibiotics, anti-malarial, dermatology, vitamins and nutritional.
Post: Corporate Quality Assurance Manager
Job Description
- Plan and provide support to manufacturing activities as per Quality Management Systems (QMS) / GMP guidelines.
- Ensure the preparedness of system/ records for external inspections/audits from regulatory agencies/certifying agencies.
- Development of Quality Assurance systems for compliance of regulatory audits, continuous improvement with risk assessment and management.
- Technical investigations, assessment of non-conformances and its management by CAPA.
- Review change control requests and deviations and analyse quality impact.
- Design and implement validation master plan.
- Monitor adherence to cGMP / Pharamacopoeial requirements;
- Review and approve all documents for technology transfer and oversee execution of the process.
- Develop & monitor sample management system for control samples, validation samples, stability samples & market/customer samples.
- Develop site master files and validation master plans of all sites.
- Identify training needs of quality teams; Conduct GMP, GLP and other training programs for employees across levels and functions;
- Provide strategic guidance to the teams which are responsible for dossier preparation / submissions, product approvals & registrations, compliance with policies and norms.
- Handle the review & approval of specification for pharmaceutical ingredients and finished products; ensuring compliance with company standards.
- Supervise & review achievements as well as monitor team performance.
- Lead the quality audit process for new & existing - RM& PM vendors, contract manufacturing sites & third party sites.
- Market complaints – Investigation, CAPA analysis, resolution of complaints & taking timely corrective action.
- Stability studies for all products (existing formulations & new formulations) as per FDA & internal guidelines and give feedback to the stakeholders.
- Establish effective plans, quality systems & procedures to assure compliance with all applicable regulatory bodies.
Candidate Profile
Qualification: B Pharm/MPharm/M Sc(Industrial/Analytical Chemistry)
Experience: 15 – 20 years of relevant experience in CQA function in reputed Indian/foreign MNC-Pharma Formulations Company. Experience in WHO - Geneva is desirable.
Additional Information:
Experience: 15-20 years
Qualification: B.Pharm/M.Pharm/M.Sc
Designation: Deputy General Manager - Corporate Quality Assurance
Location: Mumbai
Functional Area: QA
Last Date: 25th October, 2015
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