Site QA Head for an API Plant, Aurangabad in Aspiring Solutions

Job Posted on Jan 16, 2017

Company Name*:Aspiring Solutions

Aurangabad, Maharashtra 431154
Contact Person*:Reema Nambiar
Email Address*
Job Department*:Quality Assurance
Job Title*:Site QA Head for an API Plant, Aurangabad
Qualification*:MSc Chemistry
Required in*:API Unit
Job Details*:We are urgently hiring for Site QA Head for a reputed API/ Bulk Drug co. for their plant located at Aurangabad . Please find the details below:

Position: Site QA Head (Functionally QA/QC)

Department: QA/QC

Location: Aurangabad, Maharashtra

Reporting Administratively to Head-Operations

Qualification & Experience: M.Sc. with minimum 18 to 25 years experience. Should have faced regulatory audits such as USFDA, WHO-GMP, EDQM/COS, KFDA, etc. and vendor audit, customer audit, etc.

Age: 38-48 years

Job responsibilities
· To ensure efficient and effective management of Regulatory Affairs, QA & QC functions
· Monitor regulatory environment and ensure that manufacturing practices comply with the regulatory requirements
· Ensure strict compliance to cGMP/GLP guidelines in all areas of QC lab
· Prepare documentation packages for submission to various overseas regulatory agencies
· Evaluate levels of in-house regulatory compliance and prepare answers to queries from regulatory authorities
· Encourage quality improvement programs and reduce costs of quality
· Define goals for validation and decide on the scope of all validation exercises related to products, processes and facilities
· Ensure timely approval of material by quality control and also to enable timely dispatch of finished products in accordance with statutory rules and regulations and customer requirement
· Provide guidance to Training Managers and approve all cGMP/GLP training programs for technical functions
· To review and approve all cGMP related documents
· Conduct self-inspection audits as lead auditor and ensure the compliance to cGMP requirements
· To approve or reject all finished products
· To conduct vendor audits & approval of new vendors
· To review stability study data and establish expiry or retest date
· Implement corrective measures on the basis of quality audits, out of specification, deviation data and market complaint analysis
· To review and approve of documents with respect to change controls, market complaints, deviations, OOS, reprocess, OOT, returns and annual product quality review
· Approving all procedures, specifications, BPRs, laboratory control records before release
· Should have QA/QC experience

CTC range: Upto 25 lacs per annum

Industry preference: Pharma / Bulk Drugs / API

Candidates preferred from Maharashtra

If the position interests you, please email your cv at with details on current CTC, expected CTC and notice period
Regulatory Exposure*:Required
Audit Experience:USFDA, MHRA, TGA, ANVISA, WHO
Experience*:15+ Years
Vacancies *:1
Salary Per Annum:25 lacs per annum
Last Date*:28/02/2017
Additional Details:Accommodation will not be provided by the company
Note:Please send your resume to above email address to apply this job.

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