Technical Documentation Manager

3 weeks ago

Kuala Lumpur, Malaysia Pharmeng Technology Inc Full time

**PharmEng Technology** is a global ISO certified Pharmaceutical Compliance Consulting Firm with projects around the world providing quality services to the manufacturers of pharmaceutical and health care products for over 25 years.

Our 300+ global consultants have expertise in Commissioning & Qualification, Validation, Quality Systems, Engineering, Medical Devices, Modular Cleanrooms, Thermal Mapping, Training, Toxicology and Regulatory Affairs.

**PharmEng Technology** is a cGMP compliant leader with international offices in Canada, Spain, France, Germany, Austria, Switzerland, Italy, Belgium, Singapore, Malaysia, Indonesia, Taiwan, Ireland, Denmark, Brazil and USA and maintains strategic partnerships for extended capabilities internationally.

**PharmEng Technology **is seeking full-time experienced Senior CQV in Madrid.

Job Overview:

- At least 5 years of experience in CQV within Pharmaceutical Companies is required.
- Strong Semi-conductor background Commissioning lead on Mechanical systems good to have
- Technical Documentation Manager to coach and co-ordinate Mechanical system handover documentation
- English
- Malaysian local language preferred, but not mandatory

**Responsibilities**:

- Commissioning, qualification, and requalification of new or existing manufacturing and laboratory equipment, facilities, services, and systems following regulatory guidelines such as GMPs, EMA, FDA, and Health Canada.
- Knowledge of semi-conductor equipment CQV good to have
- Technical Documentation Manager to coach and co-ordinate Mechanical system handover documentation
- Leading the corresponding qualification documents such as VP, IQ, OQ, PQ and PPQ protocols and reports, risk assessments, and development protocols.
- Providing support for the development of user requirements and functional specifications.
- Actively participating in all phases of validation projects in accordance with the client needed. Evaluating projects and providing technical information to others.
- Recommending to management as to the acceptance and release of qualified equipment/ facilities, services and/or systems.
- Supporting the generation and execution of all documentation related to demonstration batches, thermal studies, validation studies for equipment, engineering test runs, development studies.
- Reviewing technical and quality system documents such as SOPs, Change Control, Deviation Reports, and Batch Production Records, ensuring any document changes meet quality and validation requirements and are in full compliance with regulations, standards, and regulatory compliance issues.
- Providing technical assistance during investigations of process /equipment / cleaning / validation issues and aid in the resolution of validation deviations, protocol discrepancies and non-conformities.
- Providing effective solutions for the management of system deviations and non-conformities through the CAPA System.

**Qualifications**:

- Bachelor's degree in technical field (engineering, chemistry, or related field)
- At least 5 years of experience in CQV activities
- Generation of qualification documents and hands-on on execution like URS, SAT, System Risk Assessment, DQ, IQ, OQ, PQ, SOPs.
- Hands on commissioning, qualification and validation experience in the following disciplines is needed:

- Major qualification equipment
- Equipment qualification
- Firm understanding of cGMP validation requirements / guidelines and familiarity with EMA, FDA, and Health Canada regulatory requirements for the Pharmaceutical/biopharmaceutical industry.
- Proven capability to assess processes, equipment, and products for sources of variation, ability to analyse data and reach appropriate conclusions, and to perform and appropriately document deviations and investigations.
- Experience with Microsoft Office Suite.

**Skills**:

- Good communication skills.
- Team Leader.
- Team player.
- Problem Solving Ability.
- Self-driven
- Attention to detail.
- Analytical Thinking.
- Stakeholder Management in a matrixed environment.

What we offer
- Full-Time Position.
- Competitive Salary.
- Sponsorship if needed.
- Opportunities working for a global company.
- Continuous Professional Improvement including, but not limited to, courses or seminars.

At **PharmEng Technology**, we don’t just accept difference — we celebrate it, we support it, and we thrive on it for the benefit of our employees, our clients, and our community. **PharmEng Technology** is proud to be an equal opportunity workplace.

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