Sr. Manager QA / QC (Pharma API/ Bulk Drug), Raigad in Aspiring Solutions

Job Posted on Jan 16, 2017

Company Name*:Aspiring Solutions

Raigad, Maharashtra 402301
Contact Person*:Reema Nambiar
Email Address*
Job Department*:Quality Assurance
Job Title*:Sr. Manager QA / QC (Pharma API/ Bulk Drug), Raigad
Qualification*:MSc Chemistry
Required in*:API Unit
Job Details*:We are urgently hiring for Sr. Manager QA-QC for a reputed API/ Bulk Drug co. for their plant located at Mahad (Raigad). Please find the details below:

Position: Chief Manager QA/QC & RA

Department: QA/QC & RA

Location: Mahad, Maharashtra

Reporting Functionally to MD/CEO and 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: 40-48 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 Regulatory Affairs experience

CTC range: Upto 25 lacs per annum

Industry preference: Pharma / Bulk Drugs / API

Candidates preferred from Chiplun, Roha, Mahad, Patalgana MIDC, Taloja Industrial Area

If the position interests you, please email your cv at with details on current CTC, expected CTC and notice period
Regulatory Exposure*:Required
Experience*:15+ Years
Vacancies *:1
Salary Per Annum:25 lacs per annum
Last Date*:28/02/2017
Additional Details:Accommodation will be provided
Note:Please send your resume to above email address to apply this job.

Follow @emfteam on Twitter | Facebook
Powered by EmailMeForm

Click Here

Write a Powerful CV

Click Here

Get App for News Updates

Scan to Download

Android App
Android App

Recent Articles