QA Executive - QMS #SgUnitedJobs
STRIDES PHARMA GLOBAL PTE. LIMITED
Healthcare / Pharmaceutical, Manufacturing, Sciences / Laboratory / R&D
S$2500 - S$4000
KEY DUTIES AND RESPONSIBILITES:
- Tracking and trending closure of deviation, OOT and change control
- Issuance, retrieval and tracking of incidents, deviations, Change Control & OSS forms
- Review SOP base on any changed pharmacopeial requirement or feedback from shopfloor or any comments from previous audit, incorporate changes, inform supervisor seek appropriate approval and authorisation to ensure update of SOPs
- Update of Site Master File (SMF) with necessary changes as and when required
- Review the log books for online entries and its correctness
- Ensure the timely revisions and availability of currents SOPs
- Ensure the SOPs are in line with the practice and revision thereof if required
- Facilitate timely completion and effective implementation of QMS system
- Ensure batch records are disposed-off on time
- Issuance of incident/deviation forms
- Review of master BMR/BPR and issuance of BMR/BPR
- Review and preparation of the SOP work instruction of related departments and verify compliance
- Online review and report of GMP non-compliance to QA Head
- Review of incidents and deviations related to exhibit, validation & qualification batches
- Involve in the generation of User Requirement Specification, preparation of Design, Installation Operational, performance protocol of equipment, utilities & facility to validate its compliance so as to meet the predefined quality attributes of the products
- Timely submission of protocols and reports related to exhibit and validation batches
- Participate in the CFT meeting related to exhibit and validation batches and ensure the completion of the pending actions prior to batch manufacturing
- Co-ordinate with QA, QC, Production and another functional departments for maintaining Quality standards and to have a continuous compliance as per regulatory requirements
- To identify and implement process improvement opportunities, cost improvement and monitor the effectiveness of the same
- Optimize usage of all existing resources, identify new/additional resources as required
- Participate in periodic reviews to ensure that business/regulatory needs are met
COMPLIANCE & QUALITY REQUIREMENT:
- Personnel must have knowledge and experience of qualification/QMS principles and their practical application
- Ability to pay attention to detail and to work independently, outstanding organizational, interpersonal and analytical skills, excellent verbal and written communication skills required
- Must demonstrate multitasking and organizational skills.
- Must be able to interact and lead effectively in a team-based environment.
- Proficient in the use of Microsoft Word, Excel, Access, PowerPoint and Explorer.
- Familiarity with regulatory/compliance (cGMP, USP, BP, FDA) in Solid oral dosage drug manufacturing.
EDUCATION & EXPERIENCE:
- Degree a scientific discipline or equivalent.
- Experience in a regulated industry preferred.
- A minimum of 4-6 years’ relevant experience in Pharmaceutical manufacturing environment
Closing on 06 Feb 2021orview more job listings from this company