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Post: Assistant Manager - Quality Assurance
Job Description
Objectives
The Manager QA External Manufacturing role is to perform the role of the Site QA manager for External Manufacturing (EMs) sites in the Asia Pacific region.
The Asst. Manager / Manager QA External Manufacturing will work with the Managers and Director EM,
Senior Manager / Director QA External Manufacturing Asia Pacific, QC ww Account Directors GTO and local affiliate Quality Executives and management, J&J Consumer QTA and other parties to: ensure Quality and Compliance of J&J products produced by EMs. reduce the risk to J&J associated with the EMs. timely, efficient and cost conscious resolution of issues and release of products from EMs to meet market requirements.
Job Responsibilities
* Plan, participate, and follow up audits, evaluations and technical visits to achieve objectives
* Support EMs with quality and compliance activities including quality agreements, deviations, investigations complaints, product disposition, change control, product transfers, risk assessments and recalls
* Influence and build relationships with EMs and other internal parties to achieve objectives.
* Report on EM performance and issues via metrics and reports.
* Provide EMTA intelligence on EM, regulatory, market related issues.
* Ensure compliance with applicable J&J and JSC policy, procedure and guidance.
* Meet personal, EM QA, EMTA and JSC/ESIQ goals and objectives
* Undertake consulting, training and improvement projects with EMs to achieve objectives
* Undertake other projects and duties to support EMs and EM QA objectives as required.
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Qualifications
* Technical skills extensive knowledge of GMPs, validation, Quality systems, PE
* Interpersonal skills to build long term relationships, influence up and down, negotiate acceptable outcomes, multiple disciplinary, cross-cultural environments in EMs and J&J.
* Wide range of experience gained in at least 10 years in the pharmaceutical industry ideally including a combination of the following:
* QA, manufacturing, engineering, QC, development,
* solids, liquids steriles, devices and combination dosage forms
* multiple company, multiple country
* Business and customer focus
* Flexibility ability to travel across the AP region and to handle ambiguous situations, independence and self-sufficiency
Additional Information:
Qualification: Any
Location: Maharashtra-Greater Mumbai
Functional Area: QA
Industry Type: Pharma/Biotech/Clinical Research
End Date: 30th April, 2016
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