- Min. 10 yrs. of experience in Pharma Industry preferably in QA
- Experience of leading 7-8 members
- Hands on experience of implementing Quality system & Regulatory Audits
- Experience of Licensing process with Local FDA and CDSCO
- Auditing skills, Experience of developing CAPA plans
Through knowledge of cleaning validation.
- In depth knowledge of Clean room operation, maintenance and qualification
- AHU operation and qualification
- Knowledge of do and dont's in Jet milling / microniser.
- Exposure to analytical testing like UV absorbance, moisture analysis and PSD by Malvern.
- Review of analytical reports and manufacturing records.
- Water system operation, maintenance and Qualification.
- In depth knowledge of SOP and validation protocol / report preparation.
- Good Investigation skills to handle OOS, deviation , incidents, customer & complaints.
- Good communication skills
Salary: Not Disclosed by Recruiter
Industry: Pharma / Biotech / Clinical Research
Functional Area: Supply Chain, Logistics, Purchase, Materials
Role Category: Purchase/Material Management
Role: Quality Assurance/Quality Control Manager
Employment Type: Permanent Job, Full Time
Desired Candidate Profile
Education:UG -B.Sc - Bio-Chemistry, Chemistry, B.Pharma - Pharmacy
PG - MS/M.Sc(Science) - Bio-Chemistry, Chemistry, M.Pharma - Pharmacy
Doctorate - Doctorate Not Required
BEC Chemicals Pvt. Ltd.
BEC Chemicals Pvt. Ltd., was founded by Late Mr. M. T. Shah in 1979 and is specialized in manufacturing of Active pharmaceutical Ingredients (API's) and Intermediates. The company's head office is based in Mumbai (close to the International Airport) and manufacturing unit at Roha (125 kms from Mumbai). The manufacturing unit has been approved by Indian, American ,European and Japanese Drug Authority and is EU-GMP, USFDA , WHO-GMP , State GMP and PMDA Certified. The company is ISO 9001:2008, 14001:2004, 18000:2007, OHSAS certified by SGS-UK. The manufacturing unit is an 100% Export Oriented Unit and is recognized as STAR EXPORT house by DGFT (INDIA).
The company's corporate policy primarily focuses on Product Quality, Customer Satisfaction, Patient's Safety, Health & Safety Measures, Training, Team Work, Social Responsibilities, monitoring thrive for Continuous Improvements which has resulted into trust and confidence among our International customers. We are a R&D driven company wherein, our Research and Development centre (situated in Mumbai) has been recognized by the Department of Science and Technology as DSIR Approved. We undertake contract research and new process development work for generic APIs under confidentiality agreements. The R&D is well equipped to undertake projects from Lab scale to Kilo scale, with complete technical package as per CTD format.