Job Description:
1 .  Contract/External Manufacturer   Quality Oversight

Quality oversight of contract manufacturers        including: OOS/NCR/Deviation and CAPA, Change Control and routine        stability testing monitoring.  On time and in compliance to GMP and        applicable standards.
Release   of Products

· No recalls or Critical product   quality issue on product in the market due to batch release oversight.

· Release timeframe within   target timeframe.

Change   Control

· Actioning individual   change controls.

· Oversight and management   of change control process.

· Change Controls and tasks   to be actioned within the defined target dates and in compliance to GMP and   SOPs.

Artwork review according to requirements.

Deviations,   NCR & CAPA

· Actioning individual   deviations, NCR & CAPA.

· Oversight and management   of process.

· Deviations to be   completed in compliance with GMP and SOPs and in alignment with   timeframes of business needs.

· No recalls or Critical   product quality issue on products in the market due to due diligence oversight.

Customer   Complaints

· Work with internal   departments and 3rd party suppliers to maintain oversight of the   complaints process to ensure complaints are managed according to compliance   requirements.

· Complaints resolved   within required timeframes as defined in SOPs and according to the compliance   requirements of regulations and SOPs.

· Timely reporting of   complaints.

Document   Management

· Update of SOPs/WIs/FGS as   per position responsibility.

· All documents under   responsibility to be maintained and updated within the required due dates and   in compliance with regulations and SOPs.

Internal   and External Auditing

· Follow up of any NCR/CAPA   identified.

· Ensure audits are   conducted within the defined timeframes and in compliance to regulations and   SOPs where applicable.

· Facilitate process to   ensure that audit findings are resolved and closed out within the agreed   timeframes where applicable.

Training   and Development

· Individual training.

· Individual training to be   completed on time in full before due date.

Job Requirements: Min Degree in Life Sciences w min 3 yrs of relevant experience in pharmaceutical/medical device industry

Interested candidates, please submit your resume to: allylok@recruitexpress.com.sg

Ally Audrey Lok Xin Woon

Recruit Express Pte Ltd (Healthcare & Lifescience)

Company EA Licence number : 99C4599

Personnel EA License: R21102307

allylok@recruitexpress.com.sg