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Wednesday, December 22, 2010

DQA Sr.Mgr / Associate Director with QbD Exp required for MNC Pharma

Job DescriptionSkills:
• Should have a vision, a clear picture of the objectives of the organization and his team.

• Should demonstrate self confidence and inspire action.

• Should be good at interpersonal and leadership skills.

• Should be able to motivate the members of the team continuously and get the most out of them.

• Should have excellent communication skills
Competencies: Decision making, Business acumen, Establishing direction, Strategic thinking and Talent mindset
Operating Network: Interact with DQA team, PDTs and CROs


Send me your updated CV's with the Subject line "DQA / Sunil" to polarisindia@gmail.com .

Contact Person: Sunil
Contact Number: 09949751412
Desired Profile
QbD (Quality by Design) exp is a must for this position & he should be working for Research or Development QA.


Responsibilities:
 Enable DQA team members to enhance knowledge on various aspects of quality by providing the necessary support.

 Ensure proper review of all the documents.

 Responsible for proper audits and self inspection by the team.

 Ensure that the PDTs get adequate support from DQA members.

 Ensure a proper quality plan (controls to ensure quality in product, process, documents, procedures, etc.) for the project keeping in mind the target geography regulatory framework.

 Ensure appropriate implementation and control of change control mechanism.

 Responsible for Regulatory requirements for Clinical trial batches & Bio batches release.

 Ensure appropriate qualification of CRO (clinical research organization/contract research organization) and manufacturing sites.

 Ensure that the existing GMPs, STPs, GLPs or SOPs are reviewed and updated regularly.

Contact Details:

Contact person: Sunil

Mail id: polarisindia@gmail.com

Contact Number: 09949751412 / 04027403495 / 04027403497 / 04027403498
Experience10 - 17 Years
Industry TypePharma/ Biotech/Clinical Research
RoleHead/VP/GM-QA/QC
Functional AreaProduction, Maintenance, Quality
EducationUG - B.Pharma - Pharmacy
PG - M.Pharma - Pharmacy
LocationHyderabad / Secunderabad
KeywordsReserach Quality Assurance or Development Quality Assurance or DQA and QbD or Quality by Design
ContactSunil / R Varadarajan 
Telephone91-40-27403497

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