1. JOB DETAILS :

- Position Title: Sr. Manager - CQA

- Reports to: GM - Quality and RA

2. JOB PURPOSE:

- To lead and manage the Quality function across India operations.

3. KEY Duties and RESPONSIBILITIES include but are not limited to the following activities:

- Develop and implement the Quality Systems of the Company for various sites & products.

- 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.

SKILLS :

Experience : 12 - 18 years of relevant experience in CQA or QA/QC function in reputed Indian/foreign MNC- Pharma Formulations Company.

Experience in WHO - Geneva is desirable.

- Age: 34-42 years

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