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


Job Posted on Jan 16, 2017
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Company Name*:Aspiring Solutions
Venue*:Mahad

Raigad, Maharashtra 402301
India
Contact Person*:Reema Nambiar
Phone:09768813790
Email Address*:aspsol.recruitments@gmail.com
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 aspsol.recruitments@gmail.com with details on current CTC, expected CTC and notice period
Regulatory Exposure*:Required
Audit Experience:USFDA, MHRA, TGA, MCC, EMA, UNCST, ANVISA, WHO, HC
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.


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