Job Title (India Specific): Staff QA Engineer (Asst. Manager Quality Assurance)
Department: Quality Assurance
Location: Mumbai
Purpose of the position:
- To ensure Market Quality via programs like post-market surveillance, developing & deploying SOPs for quality compliance in product storage & distribution, Auditing of CDC/C&FA Warehouses and timely & effective closure of Audit Action Plan.
- To ensure total compliance to the requirements of Good Storage & Distribution Practices in Sales & Marketing countries.
- Quality System Compliance viz. Complaint Vigilance/Management, Change Control, NC & CAPA Management.
General Responsibilities:
- To ensure implementation of Good Storage & Distribution Practices at the C&FA and CDC warehouses, by training & education.
- Deployment of global and regional guidelines/standards at C&FA and CDC warehouses.
- Drive compliance through audits of C&FA/CDC warehouses and facilitating implementation of the audit action plan.
- Collection, testing, compilation of data and conclusion for products from retail shelf as per the plan for post-market surveillance program.
- Driving action plans arising out of the post-market surveillance studies.
- Active participation in implementation of actions arising out of a Quality Hold/Market Action.
- Planning & execution of periodic Mock Product recalls, ascertaining process effectiveness.
- Drive Quality System Compliance requirements in Sales & Marketing arena (S&M) i.e. monitoring of Non-conformances, Change control & CAPA.
- Participate in regulatory compliance audits of manufacturing plants and drive implementation of audit action plans.
- Management of complaints, ensuring on time closure, correct investigation and proper documentation. Routine trending, monitoring & reporting of complaints.
- Preparation/compilation of monthly QA Reports and quarterly Management Review decks.
Reporting Relationships:
- Reports to (Role): General Quality Assurance Manager.
- Direct Reports (Role & Number): None
Qualification:
- Education: B. Pharm / M. Pharm or M.Sc in Chemistry from a reputed university
- Sound knowledge of Good Storage & Distribution Practices, Quality system Compliance and Local/International Regulatory Guidelines/Requirements.
- Experience: Around 6-8 years in the Quality Assurance of a Pharmaceutical/Healthcare Company, of which at least last 2 years dealing in Market Quality.
- Other Skills (Certification/s): Proficiency in handling computerized software for quality system management, Conversant with local & international regulatory guidelines, Training skills, good written & oral communication, team player.
Please apply directly to anayyar@antal.com with all the details mentioned below:
- Updated CV
- Current Compensation & Benefits (Fixed + Variable + Perks)
Abhijit Nayyar
Consultant- Logistics & Supply Chain
Antal International Network
www.antal.com
402, Shalimar Morya Park, Off New Link Road, Andheri (w), Mumbai – 400 053, India
