| 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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