Incorporated in 1990, Strides Arcolab is a first generation, pharmaceutical company headquartered in Bangalore, India. With business interests in differentiated Pharma generics, branded generics, and bio-Pharma. Strides Arcolab is a valued player in the global healthcare industry.
With world-class manufacturing operations, the company has 8 manufacturing facilities presence in more than 75 countries in developed and emerging markets and an innovative R&D hub in Bangalore. The core competence is in the development and manufacture of niche and technically complex pharmaceutical products. Strides are also among the world's largest soft gelatin capsule manufacturers and have done acquisitions in South East Asia and Australian Regions. In December 2013, Agila business (injectable product line) was sold to Mylan in order to grow organically.
Post: VP /AVP-Quality Control
Job Description
- Quality Management System: Understand and implementation of QMS guidelines, develop and approve SOPs for Quality control.
Validation: Review validation repot of all processes, methods & systems in plant as per Validation Master Plan, ensure user requirements are met with & provide technical inputs to guide team on validations in order to document confirm that design meets purpose for which it exists.
- Line Testing: Ensure availability of updated vendor list & test & sampling procedures to plant, review and authorize analytical & calibration records & any Out-Of-Specifications generated in lab, resolve queries related to OOS, ensure training to analysts on recent developments in order to ensure right quality of inputs & finished goods.
System Compliance: Review and approve of all analytical reports and maintenance of working standards. Ensure specification and STPs Compliance to current pharmacopoeia requirements. Co-ordinate with QA for internal quality audits. Review of analytical trends. Participation in the Management reviews of Process performance, Quality management system and advocating continual improvement. Ensure safety in QC lab.
- People Management: Recruit, induct, place & supervise staff, set goals, review & manage performance, guide, counsel & provide feedback to staff on performance, plan & monitor training & development of staff to qualify as per the Job description. Motivate & reward staff appropriately to ensure a committed, motivated & competent team.
- Lab / Equipment Calibration & Maintenance: Evaluation of all resources of laboratory man power, equipment and material. Procurement of chemicals, standards, spares. Monitor & coordinate with F&E, HR and external instrument supplier, monitor and ensure proper qualification, maintenance, periodic calibration of all lab equipment to ensure GLP standards are met. Authorize Purchase requisition for Chemicals, outside testing labs charges and instruments.
Candidate Profile
- Software applications related to QC Instrumental, LIMS, ERP, SAP, etc.
- Should have good knowledge about the good manufacturing and laboratory practices
- Should have knowledge on regulatory guidelines related quality
- Excellent technical writing skill
- MS office, Excel & Power point presentation
- Excellent communication skills (verbal & written)
Additional Information:
Qualification: B.Pharm / M.Sc. (Required); M.Pharm (Desired)
Experience: 15 -19 years
Industry Type: Pharma
Employment Type: Full Time
Job Type: Regular
Requisition No: 1011
Location: Bangalore
Functional Area: QC
End Date: 30th April, 2015
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