QA Associate Manager

7 days ago


Jakarta, Indonesia Merck KGaA Darmstadt Germany Full time

Work Your Magic with us

Ready to explore, break barriers, and discover more? We know you've got big plans - so do we Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

**CONTRACT BASED POSITION FOR 1 YEAR**

**FUNCTIONAL AREA**

Roles that are responsible for the analysis, development, and operation of quality and risk management systems. Activities include developing standards for quality, documentation and processes as well as continuous improvement and preventive activities.

**TASK & RESPONSIBILITY**
- Provide leadership to the Quality Assurance team in the timely and effective execution of batch documentation review, quality investigation, customer complaint, stability non routine, packaging artwork, regulatory dossier compliance and ERP master data management.
- Ensure timely QA customer service for product supply both for internal and contract manufacturing production.
- Ensure validity of Quality Manual and SMF
- Manage and ensure the implementation stability study for non-routine stability studies comply with Merck global and local regulation requirement.
- Review and reporting routine & non routine stability studies for Regulatory submission (Local and Export).
- Ensure the compliance and correctness of SAP master data (PM, SFG, FG and TG) with the Authority approval, quality requirement within SAP system and approved procedure.
- Ensure availability of VMP and implementation of qualification and validation according to approved VMP and comply with Merck global and local regulatory requirement
- Ensure implementation of PQR program at site comply with Merck global and local regulation requirement
- Ensure implementation of CPV program at site
- Responsible as a back up for Quality release disposition (Usage decision and stock posting) of FG for sale, intermediate, semi-finished goods, change control or validation for the next step of Production and release for packing for Trading goods in absent of Site Quality Head.
- Responsible as back up for Quality disposition for release for packing or other internal manufacturing / packaging process and perform usage decision in SAP system in absent of QA Supervisor.
- Participate as QA lead auditor/auditor for self inspection and external GMP audit in adherence with approved planning and schedule.
- QA review and approve CAPA, and review CCP within Trackwise system and ensure the compliance with the requirement and approved procedure.
- QA assessment, review and close out Complaint and Complaint Investigation on Trackwise system and ensure the compliance with the Merck internal and local regulation requirement and approved procedure.
- QA review for deviation and Investigation on Trackwise system.
- Perform deviation assessment within Trackwise system
- Responsible as a backup for QA quality documents approval (e.g SOP and Specification) related to the product and operational in absent of Site Quality Head.
- Quality approval for Working Instruction (as delegation of Site Quality Head).
- Coordinate site e-Quality management system (Trackwise), quality documentation management system with ManGo, and other manual system for quick access and traceability.
- Prepare all Standard Operating Procedure as above responsibilities, perform periodic review and ensure the validity comply with Merck internal and local regulation requirement.
- Prepare monthly and/or annual report for all above inquiries as required by the quality system/standard procedures.
- Support and actively participate site continuous improvement program, EHS and 5R

**WHO YOU ARE***:

- Graduate degree in Pharmacy, Chemistry, Chemical Engineering, and any related field
- Minimum of 4 - 5 years of experience, in a similar role
- Shows a desire and motivation to work in a Quality and regulated environment.
- A proactive approach to all aspects of Quality.
- Fluent in both written and spoken English.
- Good communicator, dealing directly and effectively with operational teams and site QA and lab colleagues routinely.
- Strong analytical and problem-solving abilities.
- Organized and logical in defining workload


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