Job Description

Role & Responsibilities:

- Responsible for all QA activities and functions.
- Review & make necessary revisions in departmental IMS objectives, context, internal & external issues, Risk & opportunities related to QMS pertaining to quality departments.
- Coordinates and actively participates in the investigation of all customer complaints/dissatisfactions and provides written documentation including root cause and corrective and preventative action plans as required.
- Supervising the program of internal quality auditing and continual improvement to product or services.
- Coordinate and support Marketing Department for customer quality surveys and audits of facility and products when customer plans audits.
- Set up, organize and update the quality laboratories as per the needs of the organization and meet all legal compliance.
- Making sure the company is working as effectively as possible to keep up with competitors to meet the product quality norms, regulatory compliance, etc.
- Understanding the company mission, vision, policies, and objectives carefully, and communicating the same in simple language down the line. The role should ensure that people have understood the same and will be able to demonstrate it in their routine activities.
- Ensuring the integrity of the management system is maintained when changes are planned and implemented.
- Working closely with purchasing staff to establish supplier quality performance criteria and monitor supplier performance.
- Liaising with other managers and staff, particularly in areas such as R&D;, production and purchasing.
- Acting as key contact with customers' auditors and being responsible for ensuring the execution of corrective actions and ongoing compliance with customers' specifications.
- Liaise and co-operate with quality management and standards bodies (Bureau VERITAS, Indian Statistical Institute, Bureau of Indian Standards, FAFAI etc.).
- Should be able to take up the responsibility of MR/MA for IMS. Upgrade IMS system as per applicable standards.




- Review & recommend necessary revisions on departmental IMS objectives, context, internal & external issues, Risk & opportunities related to QMS.
- Change Control approvals.
- Internal audits - Resolving disputes arising in internal audits.
- External communication - G.M.QS having authority to communicate with customers in clarifying any quality, technical & regulatory queries & disputes.
- Take responsibility for the Quality Control D.P.P.M, ensuring that all procedures are relevant, current and implemented across the business and ensuring that product safety, quality and legality are not compromised.
- Ensure strict compliance of HSE guidelines by instructing executives/chemists and helper to use appropriate PPE while carrying out sampling of hazardous chemicals.
- Monitoring of Compliance of 21 CFR for GC software.
- Ensure implementation and compliance with QMS & GMP systems.
- Coordinate and handle regulatory audits (USFDA, WHO, EU and customer audits).
- Take responsibility for the implementation and compliance with QMS & GMP systems.
- Ensure to manage:
- Deviations
- CAPA
- Change Control
- Risk assessment
- Handling of Market complaints

- Ensure Review & approval of:

- SOPs
- BMR / BPR
- Validation protocols & reports

- Oversee Vendor qualification & audits.
- Load internal audits and compliance monitoring.
- Experience with electronic QMS systems (eQMS).
- Good understanding of analytical and manufacturing processes and FDA approved.
- Strong knowledge of:

- Validation (Process, cleaning, equipment)
- Qualification (IQ / OQ / PQ)
- Risk Management tools (FMEA, HACCP)

- Candidate should have solid knowledge and hands-on experience with:

- US Food and Drug Administration (USFDA) guidelines




- European Medicines Agency (EU GMP) requirements
- World Health Organization GMP Guidelines
- Good Manufacturing Practice (GMP) compliance
- ISO 9001 Quality Management Systems (QMS)
- ISO 14001 (if applicable)
- ISO 45001 (if applicable)
- SA8000 (Optional / Company – Specific)
- Data integrity principles (ALCOA+)
- Knowledge of ICH guidelines (Q7, Q8, Q9, Q10)
- Hands on experience in regulated environments (USFDA, EU, WHO etc)

- OH&S; Related:

- Execute the operational control for OHSAS/safety controls and their effectiveness study.
- Participate in the risk analysis in the initial stage & in case of any changes in material, machines, and method.

- Environment Related:

- Achieving environmental objectives, completing EMP’s.
- Ensuring product compliance wrt product specific-cum-country specific technical rules/regulations (e.g., Chemical Control regulations like REACH; Hazardous material regulations like GHS, DGRs; Food regulations, Pharma Law, Cosmetic Law, Fragrance standards, IPR, and other International/national /regional standard/law).
- Product Safety: Hazard & Safety communication including Preparation of Safety Data Sheets in accordance with Country-specific law.
- Responding / Communicating to Customers’ Queries / Questionnaires in the above areas.
- Assisting/Coordinating to help promote/enhance/implement Organization’s sustainability (e.g., SMETA) in view of the customers requirement/ Organization requirements.
- Assisting/Coordinating to help implement / maintain International Management Standards (e.g., GMP, HACCP, ISO 9001) and Product Testing from External Lab in accordance with International /national standard, in view of the customers requirement/ Organization requirements.

Behavioral Competencies

(Details to be specified by the organization)

Functional Competencies

(Details to be specified by the organization)

Role Challenges:

- To Ensure Effective Relationship with all external & Internal Stakeholders.
- To drive a Strong quality culture and be customer Centric.

📌 General Manager - Quality Assurance & Regulatory Compliance (India)
🏢 ABCD ASIA
📍 India